Archive for the ‘Research Projects’ Category
Nine U.S. Health Research Centers to Receive $255 Million
Last Updated on Tuesday, 27 July 2010 03:01 Written by admin Thursday, 22 July 2010 03:51
Nine health research centers have received funds to develop ways to reduce the time it takes for clinical research to become treatments for patients. The funds were awarded as part of the Clinical and Translational Science Awards (CTSA) program which is led by the National Center for Research Resources (NCRR), part of the National Institutes of Health.
“A critical goal of biomedical research is to transform discoveries into preventions, treatments, and cures,” said NIH Director Francis S. Collins, M.D., Ph.D. By working together, CTSAs are removing barriers to research, training new generations of clinical and laboratory research teams, and providing them with the equipment and resources they need.
Now in its fourth year, the CTSA consortium has generated resources that transform the research and training environment to enhance the efficiency and quality of clinical and translational research. Examples include a Web-based national recruitment registry that connects researchers with volunteers interested in participating in clinical studies, establishing public-private partnerships, and a portal that connects researchers with potential investigational drugs that may be useful in new ways.
The 2010 CTSAs expand consortium representation in new areas including New Mexico, Virginia and the District of Columbia, growing the consortium to 55 member institutions. The nine new institutions are:
Children’s National Medical Center, Washington, D.C.
Georgetown University with Howard University, Washington, D.C.
Medical College of Wisconsin, Milwaukee
University of California, Irvine
University of California, San Diego
University of Massachusetts, Worcester
University of New Mexico Health Sciences Center, Albuquerque
University of Southern California, Los Angeles
Virginia Commonwealth University, Richmond
View descriptions of these CTSA awardees at www.ncrr.nih.gov/ctsa2010.
“The nine institutions that have received CTSAs this year extend the geographic reach of the consortium and bring additional talent and expertise in such areas as children’s health, outreach to underrepresented communities, and systems to share research information,” said NCRR Director Barbara Alving, M.D.
The CTSA consortium now includes awardees in 28 states and the District of Columbia. When the program is fully implemented in 2011, it will support approximately 60 CTSAs across the nation.
A sixth and final funding opportunity announcement for CTSAs is available, calling for the next round of applications to be submitted by Oct. 14, 2010, with the awards expected in July 2011. For more information about this funding announcement, see www.ncrr.nih.gov/crfunding.
For more information about the CTSA program, visit www.ncrr.nih.gov/ctsa. The CTSA consortium website, which provides information on the consortium, current members and new grantees, can be accessed at www.CTSAweb.org.
The National Center for Research Resources (NCRR), a part of NIH, provides laboratory scientists and clinical researchers with the resources and training they need to understand, detect, treat and prevent a wide range of diseases. NCRR supports all aspects of translational and clinical research, connecting researchers, patients and communities across the nation. For more information, visit www.ncrr.nih.gov.
The National Institutes of Health (NIH) The Nation’s Medical Research Agency includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
TimTec Launches Division of Organic Synthesis and Medicinal Chemistry Contract Research Services
Last Updated on Saturday, 24 July 2010 04:31 Written by admin Thursday, 8 July 2010 11:39
Newark, DE, July 8, 2010 Press Release – TimTec, LLC is pleased to announce the launching of the new Division that manages Organic Synthesis and Medicinal Chemistry Contract Research Services. The emergence of the division is an evolutionarily progression for TimTecs business development. The company has been known for its expertise in organic chemistry design and supply for drug discovery for 15 years. TimTec scientists have a proven track record of providing high quality services and showing outstanding integrity to their clients.
The Head of Contract Research Services, J. C. Pelletier, PhD., has over 20 years of research experience in the US pharmaceutical industry as a hands-on medicinal chemist and project Team Leader at large companies and smaller, start-up operations. The TimTec contract research team consists of experienced, bench level scientists who have access to state of the art synthesis, analytical and quality control facilities. TimTec specialists are keenly aware of all the intricate details and chemistry challenges that go into bench-top research before a qualified lead molecule emerges.
TimTec remains flexible in delivering practical chemistry solutions molded to custom research requirements and budgets. Contract research services include, but are not limited to, flexible contracts, program management, structure-activity relationship evaluation, lead optimization, property optimization for ADME and PK, metabolite synthesis, enabling technologies (parallel synthesis, multistep synthesis, analytical chemistry), mg to kg synthesis capacity, compound distribution, and patent application preparation assistance. The Contract Research Division puts great emphasis on speed, real-time feedback, ongoing communication, superior compound quality, and the protection of clients knowledge resources and interests. Dedication to service is matched by exceptionally competitive prices.
Contact Information:
TimTec LLC
Harmony Business Park A-301
Newark DE 19711
Tel 302 292 8500
Fax 302 292 8520
info@timtec.net
http://www.timtec.net/contract-research-services.html
About TimTec
TimTec LLC is a privately held company located in Newark Delaware, USA. It was founded in 1995 and began its work in the areas of acquisition and distribution of synthetic organic and natural compounds and collections, custom synthesis, and laboratory equipment to become a full service partner for drug discovery. TimTec has established a global network of thousands of scientists from research centers around the world. International customers include major pharmaceutical, biotech, agricultural, and educational companies and institutions, which use TimTec products for research and development programs.
Molecular Templates and ImClone Systems Form Oncology Drug Discovery and Translation Research Collaboration
Last Updated on Thursday, 8 July 2010 10:36 Written by admin Thursday, 8 July 2010 10:36
GEORGETOWN, Texas, Jul 06, 2010 (BUSINESS WIRE) — Molecular Templates announced today that it has entered into a collaborative oncology drug discovery and translation research agreement with ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company.
Under the terms of the agreement, Molecular Templates will identify Engineered Toxin Bodies (ETBs) against an undisclosed oncology target of interest selected by ImClone. ImClone will conduct preclinical studies utilizing the ETBs to evaluate their therapeutic potential in oncology. Upon completion of the evaluation of the ETBs, Molecular Templates and ImClone have the option to continue exclusive development of selected ETBs by ImClone for potential commercialization by Lilly. Molecular Templates will receive upfront, milestone and royalty payments if any of the ETBs are selected for further development and commercialization. Financial terms of the agreement were not disclosed.
“We are excited to partner with a premier biologics innovator like ImClone,” said Eric Poma, president and chief executive officer of Molecular Templates. “We look forward to collaborating with ImClone to identify novel oncology therapies by leveraging our ETB technology. Given ImClone’s depth in the oncology and biologics arena, we view this partnership as validation of our novel platform and its potential to be used to discover and develop the next generation of targeted biologic medicines.”
ETBs represent a new class of small biologic therapeutics derived from modified bacterial toxins that retain the potent direct cell-kill properties, internalization capabilities, and predictable pharmacokinetics of the parent toxins, but have significantly reduced immunogenicity. These features confer a host of advantages over traditional biologic and small molecule approaches and allow for discovery of therapeutic targets that may be uniquely accessible by ETBs. Molecular Templates has created a vast library (>10(15)) of ETBs, each with distinct binding affinities that can be directly screened for cell-kill ability to rapidly identify promising therapeutic candidates based on both specificity and efficacy to a given target.
About ImClone Systems
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, is committed to advancing oncology care by developing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. Additional information about ImClone is available at www.imclone.com.
About Molecular Templates
Molecular Templates is a private biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), a next generation targeted biologics platform. Using the Direct Select Platform (DSP), Molecular Templates has created ETBs libraries that can be screened in a high throughput manner to identify novel therapeutic targets and molecules for various disease states. Molecular Templates plans to identify and develop therapeutics through partnerships with select biopharmaceutical companies as well as on its own. The company completed a series A financing in 2009 led by Sante Ventures. For more information, visit www.moleculartemplates.com.
SOURCE: Molecular Templates
Posted under Collaborations, North America, Press Releases, Research Projects | No Comments
TimTec’s Contract Research Services
Last Updated on Thursday, 8 July 2010 10:18 Written by Editor Thursday, 8 July 2010 03:22
High Quality Organic Synthesis and Medicinal Chemistry Contract Research Services at an Outstanding Value
TimTec brings 15 years of expertise in organic chemistry design and supply for drug discovery closer to your supplemental bench-top requirements by launching The Organic Synthesis and Medicinal Chemistry Contract Research Services Division. TimTec scientists have a proven track record of providing high quality services and showing outstanding integrity to their clients.
TimTec remains flexible in delivering practical chemistry solutions molded to custom research requirements and budgets. All Contract Research Services are delivered with an emphasis on speed, real-time feedback, ongoing communication, superior compound quality, and the protection of our clients’ knowledge resources and interests. We are dedicated to providing these services at exceptionally competitive prices.
The Head of Contract Research Services has over 20 years of research experience in the US pharmaceutical industry as a hands-on medicinal chemist and project Team Leader at large companies and smaller, start-up operations. We are keenly aware of all the intricate details and chemistry challenges that go into bench-top research before a qualified lead molecule emerges. Your TimTec contract research team consists of experienced, bench level scientists who have access to state of the art synthesis, analytical and quality control facilities.
TimTec Contract Research Services Start with:
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Flexible Contracts
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Program Management
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State of the Art Facilities
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Structure-Activity Relationship Evaluation
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Lead Optimization
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Property Optimization for ADME and PK
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Metabolite Synthesis
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Enabling Technologies – Parallel synthesis, multistep synthesis, analytical chemistry
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Mg to Kg Capacity
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Compound Distribution – Solid or solution, vials or plates
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Patent Application Preparation Assistance
Supplemental Services and Products:
Custom Synthesis
Compound Acquisition
Weighting and Plating
HTS compounds and compound collections – ActiMol Line of products
Posted under ADMET Studies, Drug-Like Compounds, Medicinal Chemistry, New Products, North America, R & D, Research Projects | No Comments
SGX Pharmaceuticals Announces Strategic Collaboration To Develop And Commercialize BCR-ABL Inhibitor
Last Updated on Thursday, 13 May 2010 10:22 Written by Editor Thursday, 13 May 2010 10:22
Under the terms of the agreement, SGX will receive from Novartis $25 million in upfront payments and the purchase of SGX common stock. Along with success-based milestones, but excluding royalties, total payments to SGX could exceed $515 million, including a minimum of two years of research funding.
The success of Gleevec(TM) (imatinib), the first targeted therapy in Philadelphia Positive (Ph+CML) proven to inhibit BCR-ABL, has fundamentally changed the treatment of Ph+CML. However, a subset of patients develops resistance to Gleevec or cannot tolerate therapy. For these patients there are currently no other approved treatment options. Drug candidates from SGX’s lead series, developed from its FAST(TM) proprietary drug discovery platform, have exhibited activity against wild-type and drug resistant BCR-ABL mutants, including the most challenging T315I mutant.
“Novartis is the leader in developing novel targeted therapies to treat CML,†said Mike Grey, president and chief executive officer of SGX Pharmaceuticals. “With their extensive experience developing and commercializing Gleevec as well as development of the novel investigational compound, nilotinib/AMN107, we believe they are the ideal partner with whom to develop our series of next-generation BCR-ABL inhibitors. This is a tremendous validation of our FAST technology for generation of novel lead molecules for key therapeutic targets.â€
Background on the Agreement
SGX will be responsible for completing preclinical development of the lead candidate and submitting an Investigational New Drug application with the Food and Drug Administration. SGX will also be responsible for the completion of an initial phase I clinical study, after which time Novartis will be responsible for conducting further clinical development and commercialization of the compound.
In addition to the upfront and milestone payments, SGX will receive royalty payments upon successful commercialization of products developed under the collaboration. SGX retains an option to co-commercialize, in the U.S., oncology products developed under the agreement. If exercised, the option would enable SGX to reinforce the commercial presence in the North American hematology markets which the company plans to establish with the potential launch of Troxatyl(TM) in the second half of 2007, assuming the successful completion of the ongoing Phase II/III clinical trial for the treatment of third-line acute myelogenous leukemia and regulatory approval of Troxatyl for this initial indication in 2007.
Background on CML: Prognosis and Treatments
Chronic myelogenous leukemia is a malignant cancer of the bone marrow causing rapid and abnormal growth of white blood cells. According to the National Institutes of Health, approximately 4,600 new cases of CML are diagnosed annually, accounting for 7 to 20 percent of leukemia cases. CML is associated with a chromosome abnormality called the Philadelphia chromosome. Since its approval in 2001, Gleevec has become the standard of care for Ph+ CML. Results from the IRIS study (International Randomized Interferon versus STI571), the largest clinical trial to date for newly diagnosed adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, show that 90.3 percent of patients who were initially randomized to take Gleevec were still alive after 54 months.
The prevalence of CML has increased substantially because Gleevec therapy makes it possible for patients with CML to live with the disease much longer than possible with previously used treatments. Gleevec works directly on leukemic cells by inhibiting the action of BCR-ABL tyrosine kinase, the enzyme responsible for uncontrolled growth of leukemic cells. Despite this clinical success, resistance to Gleevec has emerged in a subset of patients. Once patients lose response to optimized doses of Gleevec, the only currently approved treatment is bone marrow transplantation preceded by high-dose chemotherapy and radiation, for which many CML patients are not eligible.
“We believe that a BCR-ABL inhibitor developed through this collaboration could have the potential to be used both as a monotherapy in second-line treatment of refractory or relapsed CML, and in combination with Gleevec or another agent in first-line treatment of CML,†added Dr. Stephen Burley, chief scientific officer of SGX Pharmaceuticals.
About: FAST, short for Fragments of Active Structures, is SGX’s proprietary fragment-based drug discovery platform for rapid identification of novel, potent and selective small molecule inhibitors of drug targets. FAST addresses many of the limitations of traditional approaches utilized by large pharmaceutical companies to find lead compounds, making it an attractive technology for targets that have not yielded promising leads from high-throughput screening.
FAST is based on a proprietary fragment library of approximately 1,000 structurally diverse, low molecular weight compounds. FAST integrates a series of technologies, including:
* A high-throughput capability to generate many different crystal structures of a target protein in parallel;
* The evaluation of the library of fragments and direct visualization of bound fragments utilizing X-ray crystallography; and
* The use of novel computational and structure-based design methods and iterative synthetic chemistry to optimize these fragments into drug candidates.
SGX believes these combined technologies generate an efficient platform for drug discovery that delivers lead compounds active against a wide range of targets, while accessing high chemical diversity and the potential for good drug-like properties.
About: SGX Pharmaceuticals is a biotechnology company focused on the discovery, development and commercialization of innovative cancer therapeutics. The Company’s lead product candidate, Troxatyl(TM), is currently being evaluated in a pivotal phase II/III trial for the treatment of third-line acute myelogenous leukemia, an indication for which there is currently no approved therapy or standard of care. SGX has developed a pipeline of oncology drug candidates based on its enabling, proprietary FAST(TM) drug discovery platform, including a portfolio of next generation BCR-ABL inhibitors. FAST allows for the rapid identification of novel, potent and selective small molecule compounds for well validated but challenging targets.
source: biotechconnection.com
Posted under Collaborations, Industry News, Press Releases, Research Projects | No Comments
Eli Lilly and GlaxoSmithKline: A Tale of Two Different Pharmas
Last Updated on Saturday, 24 July 2010 04:09 Written by Editor Wednesday, 12 May 2010 01:10
New models for drug development, especially in big pharma, are being experimented by different companies. Eli Lilly (LLY) and GlaxoSmithKline (GSK) have two different models. These models do not throw out the old ones – but do offer additional routes going forward.
Lilly has a Phenotypic Drug Discover Initiative, (or PD2), launched in 2009. Lilly solicits compounds from other companies so long as they are in certain therapeutic areas (oncology, diabetes, osteoporosis, and Alzheimer’s Disease). Compound structures are sent to Lilly electronically where they are evaluated using modeling and simulation. If the compound passes the screen, the physical compound is sent to Lilly for further testing. If the compound passes the physical test, the fun begins.
All testing by Lilly is free and IP remains with the originating company or institution. What Lilly gets in return is the first right to exclusively negotiate an agreement. If talks break down, the originator keeps all the data generated by Lilly.
Having had some personal experience through my biotechnology company (IMC Biotechnology), I think this is a very interesting approach. We submitted 9 compounds to Lilly and one of them went through the screening process. The software had some minor glitches but the Lilly representatives were very helpful in addressing those glitches.
I think this is a great way for Lilly to expand its repertoire of compounds beyond those invented by its chemists. Certainly one way of going beyond the NIH (not invented here) syndrome.
GSK has come up with an opposite approach where it is offering its library of compounds to researchers in a certain therapeutic area (under-served tropical diseases). For example, it is offering 13,500 compounds that appear to work in malaria. GSK will let other scientists try to develop malaria drugs — free from royalties or other payments to GSK. They were narrowed down from more than 2 million compounds.
More unusual is its open lab project. GSK plans to give up to 60 outside scientists from around the globe access to what it called the “Open Lab,” at an existing company research lab in Spain. Researchers from universities, foundations, etc will be able to use the facilities to try to develop new medicines for diseases plaguing poor countries.
GSK is to start a foundation to fund research and idea sharing, kicking in $8 million initially. It also plans to work with the Emory Institute for Drug Discovery. I have worked a bit with the Emory Institute of Drug Discovery and know they have an excellent drug development team, but have not learnt anything from them about what their exact role in this project is going to be.
While a small fraction of overall R&D efforts, it nevertheless is a significant departure from business as usual. And while GSK does not expect to get royalties, the halo effect, especially with health care reform in the spotlight, cannot be neglected. One could criticize GSK in pointing out that the company does not have much to lose by sharing data in neglected diseases – and that it is not doing so in the more lucrative markets such as oncology. But I doubt that the millions of patients suffering from malaria and TB will support such criticism. New models for drug development, especially in big pharma, are being experimented by different companies. Eli Lilly and GlaxoSmithKline have two different models. These models do not throw out the old ones – but do offer additional routes going forward.
So the two companies have differing strategies that actually could be quite synergistic. Maybe it is time to pay the ultimate compliment and copy each other.
source: seekingalpha.com
SCYNEXIS, Inc. Receives Milestone Payment From Collaboration With Merck & Co., Inc.
Last Updated on Wednesday, 5 May 2010 10:43 Written by Editor Wednesday, 5 May 2010 10:43
RESEARCH TRIANGLE PARK, NC — 12/17/09 — Drug discovery and development company SCYNEXIS, Inc. announced today that it has achieved a third milestone in its collaboration with Merck & Co., Inc. to develop novel antifungal agents. This latest milestone payment was triggered following the initiation of clinical development for a compound derived from the program.SCYNEXIS and Merck initiated the antifungal agent discovery and development program in 2002. SCYNEXIS contributed medicinal chemistry, computational chemistry, bioanalytical and ADMET support to this program. Merck is responsible for development once compounds are accepted as pre-clinical candidates. Under the terms of the collaboration, SCYNEXIS is eligible to receive additional milestone payments and up to double-digit percentage royalties on worldwide sales of any product resulting from the program.
“SCYNEXIS is pleased to reach this important clinical milestone in collaboration with our valued partner, Merck,” noted Yves Ribeill, Ph.D., President and Chief Executive Officer of SCYNEXIS. “This is the eleventh time in SCYNEXIS’ ten year history that a compound originating from our discovery platform has advanced into the clinic — an accomplishment we believe speaks strongly to the strength of our capabilities.”
About SCYNEXIS
SCYNEXIS is a premier drug discovery and development company headquartered in Research Triangle Park, N.C. SCYNEXIS’ mission is to be the leader in delivering effective and innovative drug pipeline solutions to its pharmaceutical partners.
SCYNEXIS research teams integrate medicinal chemistry, advanced biological screening, ADMET-PK, bioanalysis and analytical chemistry, process chemistry, cGMP API manufacturing, and use powerful, proprietary technologies such as the HEOS® Software Suite and MEDCHEM-FACTORY® to advance molecules to candidate selection. The fully integrated research and development teams at SCYNEXIS have been tailored to be especially effective in moving customer projects from the discovery phase to the clinic. www.scynexis.com
For further information, please contact:
SCYNEXIS, Inc.
Terry Marquardt
Executive Director, Market Development & Communications
Email Contact
Tel: +1-919-544-8603
SCYNEXIS Media Contacts:
Rick Rountree
Rick Rountree Communications, Inc.
Email Contact
Tel. +1 919-878-1144
Sarah Cavanaugh
MacDougall Biomedical Communications
Email Contact
Tel. +1 781-235-3060
Source: earthtimes.org
Posted under Press Releases, Research Projects | No Comments
Karwar scientist’s theory to ‘weed’ out CO2
Last Updated on Thursday, 28 January 2010 06:05 Written by Editor Thursday, 28 January 2010 06:05
KARWAR: While representatives of 192 countries are engaged in climate change debates at Copenhagen, Dr Ullas Naik, a marine scientist at the department of marine biology, at Karnatak University’s PG Centre, here has suggested the unassuming sea weed as a possible cure to the planet’s ills.Calling for the scientific culture of algae, commonly known as sea weed and its conservation and protection, Naik points out that these algae provide much of the earth’s oxygen. They absorb carbon dioxide from the environment and carry out photosynthesis to enhance the productivity.Naik, who presented a paper on his findings at a seminar at the university recently, says the discovery has shown that these marine weeds have a remarkable ability to detoxify serious organic pollutants such as TNT or polycyclic aromatic hydrocarbons.According to him, these algae have an intrinsic ability to detoxify TNT 5-10 times faster than any known terrestrial plant.Since some of the marine organisms, particularly marine invertebrates like clamps, shrimp, oyster or crab, the staple food for many, tend to accumulate toxins, growth of sea weeds will have important implications for sea food safety, he asserts.Marine algae contain protein (5- 10%), fat (0.5-1.5%), ash (10-18%), fibre (3-6%) and carbohydrates (40-60%). He says they are rich in minerals and vitamins and can be used as food.The bioactive compound found in seaweeds have variety of applications in pharmaceutical field. Naik says attempts should be made for screening pharmaceutically active compounds from seaweeds. In fact, seaweeds will be the medicinal food of this century, Naik opines.Cautioning that these “wonderful marine species’’ should be explored scientifically, he says they can be used as manure and fodder.
Posted under Press Releases, Reports, Research Projects | No Comments
Aeolus Drug Protects the Gastrointestinal Tract in Acute Radiation Syndrome Studies Sponsored by the National Institutes of Health`s National Institute for Allergy and Infectious Diseases
Last Updated on Wednesday, 2 December 2009 12:12 Written by Editor Wednesday, 2 December 2009 12:12
* AEOL 10150 Effectively Increases Regeneration of GI Stem Cells and Reduces the
Severity and Duration of Diarrhea
* Drug Improves Survival When Administered 24 Hours after Total Body
Irradiation
MISSION VIEJO, Calif.--(Business Wire)--
Aeolus Pharmaceuticals, Inc. (OTCBB: AOLS) announced today that recent
experiments in preclinical models conducted by the National Institutes of
Health`s (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
Radiation/Nuclear Medical Countermeasure Development program have shown that
AEOL 10150 can effectively increase regeneration of gastro-intestinal (GI) stem
cells, reduce the severity and duration of diarrhea and improve survival when
administered at 24 hours after doses of total-body irradiation that produce the
lethal GI syndrome. There are no published studies of agents that accomplish
this enhanced stem cell regenerative effect while maintaining GI function and
improving survival when administered post irradiation.
"The Aeolus drug AEOL 10150 passed our first phase of rigorous testing and
showed definitive effects on crypt stem cells and other secondary parameters
used to assess drug efficacy in ameliorating the acute GI syndrome," stated
Catherine Booth, Ph.D., Managing Director, Contract Research Services at
Epistem, Ltd. "This is one of few drugs shown to affect 'both' stem cell crypt
regeneration and survival in a syndrome that heretofore has been resistant to
mitigation with drugs administered at 24 hours post lethal exposure."
NIAID has a contract with the University of Maryland to provide product
development support services for the development of countermeasures against
radiation exposure. These studies are being conducted by Epistem, a
subcontractor of the University of Maryland, in compliance with criteria of the
FDA that are a pre-requisite for movement of the Aeolus drug along the pathway
for FDA licensure to treat lethally irradiated persons in the event of a
terrorist nuclear act. Epistem operates a major contract research organization
and provides services to identify novel drugs that can protect or improve the
repair of the gastrointestinal (GI) tract following exposure to irradiation and
performed these studies as part of its US NIH`s program for the screening of a
novel agents for bio-defense applications.
The NIH NIAID Radiation/Nuclear Medical Countermeasure Development program leads
the U.S. effort to develop treatments for radiation sickness following a nuclear
terrorist attack. GI-ARS is a massive, currently untreatable, problem following
high-dose, potentially lethal radiation exposure. Agents that mitigate these
effects would reduce sickness and hopefully prevent fatalities. The tests
performed by NIH/NIAID are also likely to identify agents with oncology
supportive care applications - agents that will reduce the severe ulceration and
diarrhea (mucositis) experienced by patients during radio- and chemo-therapy.
Risk of injury to the intestine is dose-limiting during abdominal and pelvic
radiation therapy-interventions that limit post-irradiation intestinal
dysfunction would have significant impact in large number of patients, estimated
to be between 1.5 to 2 million cancer survivors with post-irradiation intestinal
dysfunction. AEOL 10150 has previously demonstrated protective effects in
protecting healthy normal cells from damage occurring due to cancer radiation
therapy in preclinical models.
Radiation Damage to the GI Tract
The intestinal epithelium, a single layer of cells lining the surface of the GI
lumen, is responsible for vital functions of nutrient absorption, maintaining
fluid and electrolyte balance and protection of the body from bacteria,
bacterial toxins and non absorbed materials. The functional integrity of the GI
system is maintained via incessant production of epithelial cells from
specialized stem cells located in crypts at the base of the epithelium.
High-dose, total-body irradiation can result in a lethal GI syndrome that
results in significant morbidity and mortality within days consequent to killing
of the crypt stem cells and loss of the protective and absorptive epithelial
barrier. There are no FDA-approved drugs or biologics to treat the acute GI
syndrome.
About AEOL 10150
AEOL 10150 is a small molecule that catalytically consumes reactive oxygen and
nitrogen species (free radicals). The compound is a manganoporphyrin that
contains a positively-charged manganese metal ion that is able to accept and
give electrons to and from reactive oxygen species ("ROS") and reactive nitrogen
species ("RNS"). Research has shown that ROS and RNS have important cell
signaling roles, and through its interaction with RNS and ROS, AEOL 10150
appears to have multiple mechanisms of action including anti-oxidant,
anti-inflammatory and anti-angiogenic activities. In preclinical studies AEOL
10150 has demonstrated reductions in the markers for tissue hypoxia,
angiogenesis, inflammation and oxidative stress. Specifically, AEOL 10150 is
able to down-regulate oxidative stress and severe inflammation, which is
responsible for much of the tissue destruction that occurs as a result of
radiation exposure.
AEOL 10150 offers several unique advantages as a countermeasure for the
treatment of ARS, mustard gas and chlorine gas for civilian and military
populations. These include:
-- Flexible Treatment Paradigm - AEOL 10150 is intended for the treatment of
patients post-exposure, even in those who are already exhibiting symptoms,
eliminating the need for immediate administration in a predefined treatment
window. This approach has the added benefit of not requiring biodosimetry (a
means of laboratory analysis of the blood to determine the level of radiation
exposure).
-- Advanced Development Stage - AEOL 10150 has demonstrated safety in three
human clinical trials, and has an extensive pre-clinical safety and toxicology
package completed. The product also has an established stability profile that
permits long-term storage.
-- Large scale manufacturing - Aeolus has contract capacity with a large
manufacturing site to mass produce large quantities of AEOL 10150 under GMP
conditions.
-- Multiple Applications - AEOL 10150 has demonstrated protective effects
against radiation and mustard gas exposure, and within these indications has
shown the ability to treat multiple organ systems.
-- Commercial Application - Additionally, AEOL 10150 is being developed for use
as an adjunct to cancer radiation therapy, and preclinical data suggest that the
compound protects healthy normal cells from the effects of radiation without
compromising the efficacy of the radiation in killing tumor cells.
Potential for AEOL 10150 as a Countermeasure Against Multiple Terrorist Threats
AEOL 10150 has shown significant protective effects against radiation and
mustard gas in preclinical models. Additionally, based on its mechanism, it is
believed that the compound may potentially protect against exposure to chlorine
gas. Studies have been initiated to further explore AEOL 10150`s ability to
protect the lungs from damage due to exposure to mustard gas and chlorine gas. A
compound with the potential to protect against multiple threats would be of
significant benefit in both the military and civilian efforts to protect
citizens against potential threats. The FDA has a special rule under which
compounds may be approved for use against chemical and nuclear threats on the
strength of preclinical efficacy studies, which allows the potential for an
accelerated approval path versus conventional pharmaceutical applications.
About Aeolus Pharmaceuticals
Aeolus is developing a variety of therapeutic agents based on its proprietary
small molecule catalytic antioxidants, with AEOL 10150 being the first to enter
human clinical evaluation. AEOL 10150 is a patented, small molecule catalytic
antioxidant that mimics and thereby amplifies the body`s natural enzymatic
systems for eliminating reactive oxygen species, or free radicals. Studies
funded by the National Institutes for Health are currently underway evaluating
AEOL 10150 as a treatment for exposure to radiation, mustard gas and chlorine
gas. Additionally, the Company has funded mouse and non-human primate studies
necessary to seek approval of the compound as a treatment to protect and/or
mitigate radiation-induced damage to the lungs for which there are no
FDA-approved drugs. Radiation-induced pneumonits and/or fibrosis are potentially
lethal delayed effects of acute radiation exposure. The ability to control these
delayed consequences will also translate into the clinic and further emphasize
the dual utility of AEOL 10150.
About Epistem, Ltd.
Epistem is a biotechnology company commercializing its expertise in epithelial
stem cells in the areas of oncology, gastrointestinal diseases and
dermatological applications. Epistem develops innovative therapeutics and
biomarkers and provides contract research services to drug development
companies. The Group`s expertise is focused on the regulation of adult stem
cells located in epithelial tissue, which includes the gastrointestinal tract,
skin, hair follicles, breast and prostate. Epistem does not conduct research in
the areas of embryonic stem cells or stem cell transplantation. Epistem operates
three distinct business divisions, Contract Research Services, Novel Therapies
and Biomarkers.
Epistem`s Contract Research Services division provides scientific expertise and
preclinical research models to the NIH`s research programme on Radiation/Nuclear
Medical Countermeasure Development. This research programme, funded by the
National Institute of Allergy and Infectious Diseases through a contract with
the University of Maryland School of Medicine, tests drugs from early screening
through advanced development for the prevention and treatment of radiation
sickness following exposure to high dose radiation following a nuclear terrorist
attack. Epistem has developed its proprietary models to provide a unique insight
into the mechanisms of intestinal damage and repair following radiation
exposure. Epistem`s models evaluate the efficacy, mechanism of action, optimal
drug dosing and scheduling of potential new treatments. Epistem has an
eight-year track record of providing testing services to over 130 international
company clients in the United States, Europe, and Japan.
The statements in this press release that are not purely statements of
historical fact are forward-looking statements. Such statements include, but are
not limited to, those relating to Aeolus` product candidates, as well as its
proprietary technologies and research programs. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors that may cause
Aeolus` actual results to be materially different from historical results or
from any results expressed or implied by such forward-looking statements.
Important factors that could cause results to differ include risks associated
with uncertainties of progress and timing of clinical trials, scientific
research and product development activities, difficulties or delays in
development, testing, obtaining regulatory approval, the need to obtain funding
for pre-clinical and clinical trials and operations, the scope and validity of
intellectual property protection for Aeolus` product candidates, proprietary
technologies and their uses, and competition from other biopharmaceutical
companies. Certain of these factors and others are more fully described in
Aeolus` filings with the Securities and Exchange Commission, including, but not
limited to, Aeolus` Annual Report on Form 10-K for the year ended September 30,
2008. Readers are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof.
Aeolus Pharmaceuticals, Inc.
John L. McManus
President and Chief Executive Officer
1-949-481-9825
Source: reuters.com
Copyright Business Wire 2009
Scripps research scientists take step in stem cell work
Last Updated on Tuesday, 1 December 2009 12:59 Written by Editor Tuesday, 1 December 2009 12:59
A team led by scientists from The Scripps Research Institute has developed a method that dramatically improves the efficiency of creating stem cells from human adult tissue, without the use of embryonic cells. The research makes great strides in addressing a major practical challenge in the development of stem-cell-based medicine.
The findings were published in an advance, online issue of the journal Nature Methods on Sunday.
The new technique, which uses three small drug-like chemicals, is 200 times more efficient and twice as fast as conventional methods for transforming adult human cells into stem cells (in this case called “induced pluripotent stem cells” or “iPS cells”).
“Both in terms of speed and efficiency, we achieved major improvements over conventional conditions,” said Scripps Research Associate Professor Sheng Ding, Ph.D., who led the study. “This is the first example in human cells of how reprogramming speed can be accelerated. I believe that the field will quickly adopt this method, accelerating iPS cell research significantly.”
In addition to its significant practical advantages, the development of the technique deepens the understanding of the biology behind the transformation of adult human cells into stem cells.
The hope of most researchers in the field is that one day it will be possible to use stem cells – which possess the ability to develop into many other distinct cell types, such as nerve, heart, or lung cells – to repair damaged tissue from any number of diseases, from Type 1 diabetes to Parkinson’s disease, as well as from injuries. The creation of iPS cells from adult cells sidesteps ethical concerns associated with the use of embryonic stem cells, and allows the generation of stem cells matched to a patient’s own immune system, avoiding the problem of tissue rejection.
The creation of human iPS cells was first announced in December 2007 by two labs, one in Japan and another in Wisconsin. In both cases, the teams used viruses to insert multiple copies of four genes (eg. c-Myc, Oct4, Sox2, Klf4) into the genome of skin cells. These four genes then produced transcription factors turning on and off other genes, and pushing the cell to “dedifferentiate” into stem cells.
While the work was a major breakthrough, it left two major challenges for the field to solve before iPS cell therapy could be considered of any potential practical use. The first involved safety, since the technique relied on potentially harmful genetic manipulation, and worse yet, the insertion of two known cancer-causing genes (c-Myc and Oct4). The second problem was the length and inefficiency of the iPS cell process, which had a success rate of roughly one in 10,000 cells and took about four weeks from start to finish.
Ding and colleagues essentially solved the first problem, the reliance on genetic manipulation, earlier this year in a paper published in Cell Stem Cell (Volume 4, Issue 5, May 8, 2009). In the paper, the researchers demonstrated that they could use purified proteins to transform adult cells all the way back to the most primitive embryonic-like cells, avoiding the problems associated with inserting genes.
In the current paper, the team makes major strides in solving the second problem, efficiency.
In developing the improved method, Ding drew on his knowledge of biology. He decided he would focus his efforts on manipulating a naturally occurring process in cells, in particular in a type of adult cell called fibroblasts, which give rise to connective tissue.
This naturally occurring process – called MET (mesenchymal to ephithelial cell transition) – pushes fibroblasts closer to a stem-cell-like state. If he could manipulate such a fundamental process to encourage MET and the formation of stem cells, Ding reasoned, such a method would be both safer and more direct than hijacking other aspects of biology, for example those directly involved in cancer.
“People have studied this mechanism for 10 to 20 years,” said Ding. “It is a fundamental mechanism.”
Ding and colleagues tested a number of drug-like molecules, looking for those that inhibited the TGFï¢ (transforming growth factor beta) and the MEK (mitogen-activated protein kinase) pathways, which are known to be involved in the MET process. The researchers identified the most active compounds, then looked at their effects on stem cell creation when used singly and in combination.
The researchers found two chemicals – ALK5 inhibitor SB43142 and MEK inhibitor PD0325901 – used in combination were highly effective in promoting the transformation of fibroblasts into stem cells.
“This method is the first in human cells that is mechanism-specific for the reprogramming process,” said Ding.
And the two-chemical technique bested the efficiency of the classic genetic method by 100 times.
Efficient, Fast, Safe
But the researchers thought they might be able to do even better.
Attempting to increase the efficiency of the process even further, the team decided to enlist another natural pathway, the cell survival pathway. After screening a library of compounds targeting this pathway, the team focused on a novel compound called Thiazovivin.
The researchers found that a technique using Thiazovivin in combination with the two previously selected chemicals, SB43142 and PD0325901, beat the efficiency of the classic method by 200 times.
In addition, while the classic method required four weeks to complete, the new method took two weeks.
In addition to its virtues of speed and efficiency, Ding emphasizes that the safety profile of the new method is highly promising. Not only is the method based on natural biological processes, he said, but also the type of molecules used have all been tested in humans.
In addition to Ding, the article, “A Chemical Platform for Improved Induction of Human iPS Cells,” was authored by Tongxiang Lin (first author), Rajesh Ambasudhan, Xu Yuan1, Wenlin Li, Simon Hilcove, Ramzey Abujarour, Xiangyi Lin, and Heung Sik Hahm of Scripps Research, and Ergeng Hao and Alberto Hayek of The Whittier Institute for Diabetes, University of California San Diego.
The research was supported by the National Institutes of Health and Fate Therapeutics.
Source: lajollalight.com
Posted under Press Releases, Research Projects, Stem Cell Research | No Comments
High-Content Screening Surges Ahead
Last Updated on Tuesday, 1 December 2009 11:33 Written by Editor Tuesday, 1 December 2009 11:33
High-content screening (HCS) and the technology to do it faster, on more compounds in a shorter period of time, and to generate quantitative, multiparametric data took center stage at CHI’s “High Content East†meeting held in Boston last month. Presenters described how they are implementing enhanced screening systems, image-analysis methods, and data-management strategies to achieve daily HCS runs on tens of thousands of wells and screening campaigns totaling 200,000 to 3 million wells.
High throughput HCS—albeit not yet reaching the numbers common for conventional high-throughput screening (HTS) and with lingering limitations and challenges related to live-cell imaging over time—is making its mark and being used to probe the biological basis of disease and to detect even subtle phenotypic changes in response to experimental compounds.
Determining whether a cell looks like a cancer cell, for example, typically requires being able to detect subtle morphological changes, such as small alterations in size or structure, changes in the connections a cell makes with neighboring cells, or variations in the texture of staining. These have, historically, been mainly qualitative parameters detected by studying and comparing images of cells.
In her talk at the conference, Anne Carpenter, Ph.D., director of the imaging platform at the Broad Institute of Harvard University and MIT, presented her group’s work using HCS and image analysis to quantify difficult phenotypes and differentiate disease states such as leukemia.
Not only do HCS systems and image-analysis software automate the screening process, enabling theanalysis of many more cells in less time and increasing the chances of detecting even small numbers of altered cells, they can also utilize algorithms that evaluate defined combinations of parameters in a quantifiable manner and apply techniques to distinguish between clumping or closely juxtaposed cells. Relying on computer-based image analysis also standardizes the process, eliminating factors such as variability in human expertise and experience, consistency, and fatigue.
Dr. Carpenter’s group uses machine-learning methods to train image-analysis software to identify subtle phenotypic changes. Biologists work with the software in an iterative fashion in a process called supervised machine learning. They teach and correct the computers on a series of test images, refining the system’s knowledge base in a process that typically takes less than a day. The group developed the algorithms used by the biologists and has made them available as open-source software.
A recent paper published in PNAS by T. R. Jones, et al., documents the use of a trained image-analysis system to discriminate 15 different cellular phenotypes. Other projects involve teaching the software to discriminate leukemic from normal cells, to identify liver cells that are growing normally in culture—to aid in the development of physiologic models of liver function for use in drug testing—and training computers to detect subtle changes that signal the initiation of cell division for studying cell-cycle regulation in cancer.
Neil Carragher, Ph.D., senior scientist in the advanced science and technology laboratory at AstraZeneca, described how the company is applying high-content and live-cell imaging techniques and integrating the results with data derived from in vivo imaging and proteomic studies to improve clinical predictability.
Dr. Carragher’s group combines the results of high-content in vitro and in vivo assays to generate mechanistic information about phenotypic responses on candidate therapeutic compounds. The goal is to create a multiparametric fingerprint of a phenotype from images generated by HCS and to use this knowledge to enhance predictions of efficacy and toxicity early in drug discovery and reduce attrition later in development.
The phenotypic signatures are based on measurements of approximately 150 different parameters per cell for each assay. Data from multiple assays is collated for every test compound and compared with data obtained using well-characterized reference compounds to generate mechanistic hypotheses.
Only recently has open-source and commercial software become available “that allows you to quantitate more complex phenotypes, subtle changes, and heterogeneous responses from images,†Dr. Carragher said.
His group is employing two main approaches—each with different advantages and limitations. The first strategy relies on Definiens’ Cognition Network Technology™ software that allows users to develop algorithms that capture, computationally, what researchers can see visually. “It is very much context-based†and identifies objects based on how they are related to others in the image, rather than as individual pixels, explained Dr. Carragher. The in-house algorithm-development process depends on iterative programming steps. The other approach involves machine-learning tools using software such as the CellProfiler developed at the Broad Institute.
Redirecting Approved Drugs
| Identifying new applications for FDA-approved drugs using HCS and image-based systems biology is the focus of work being done by Stephen Wong, Ph.D., founding director of the bioinformatics and biomedical engineering program and the cellular and tissue microscopy core at the Methodist Hospital Research Institute and professor of radiology and neurosciences at Weill Cornell Medical College.
Dr. Wong gave examples of screening campaigns to decipher targets in the pathways responsible for the metastasis of breast cancer to the brain in his talk. He specifically described the computational tools his group is developing for high-content and network analysis, and the animal-imaging techniques being used to evaluate combinations of small molecule chemotherapeutic agents for their ability to cross the blood-brain barrier and to have an effect against central nervous system metastases in breast cancer. Dr. Wong’s group has also developed a series of quantitative image-analysis tools, including zebrafish image quantifier (ZFIQ), as well as software for studying neuronal spines (NeuronIQ), neurites (Neurite IQ), and time-lapse mitotic events in cells (DCellIQ). Dr. Wong’s HCS/systems biology research is funded by the NCI, NIA, and NLM. Because the compounds being studied are already approved drugs, Phase I trials are not needed. The quantitative data generated from HCS provides the evidence necessary for moving into Phase II studies, shortening the drug-development cycle to a year or less. The types of studies essential to Dr. Wong’s efforts, such as assays to monitor cell-cycle regulation or dendritic spine dynamics, require time-lapse, live-cell imaging. Looking at fixed cells provides only an artificial snapshot of where cells are at a particular point in time, explained Dr. Wong. “We want to look at a 384-well plate of continuously growing cells over five to six days,†he said, and in his view none of the instrument manufacturers competing in the HCS market has yet to provide a robust, incubator-based, environmentally controlled system that can achieve this. Vendors have tended to view HCS as just another type of high-throughput screening, but live-cell imaging done in as natural an environment as possible has quite different requirements, contended Dr. Wong. “Vendors are going in the wrong direction. The power of HCS is in the ability to visualize things in action and to extract lots more quantitative information from the images. If you, instead, retrofit HCS to HTS, you are losing its advantages,†such as the ability to see cells or spines change over time, to visualize cell-cell interactions, and to sync cell populations and study cell-cycle events in time-lapse, said Dr. Wong. In any experiment, “if you generate enough data you will get hits, but how many will be real hits versus false positives?†asked Dr. Wong. “We need to push the quality upfront on the biology side†and screen out, earlier in the discovery process, compounds that are destined to fail. Researchers at Pfizer are using HCS to study the genetic variation and physiologic interactions that underlie hepatic insulin resistance in type 2 diabetes and the prediabetic state. Diabetes is a complex, multigenic disease, and while advances in genomic and SNP-based technologies have led to the identification of at least 30 genes that contribute to the diabetic phenotype, much work remains to understand their role in cell biology and disease and how they interact. “If you are careful about the cell models you choose, you can use HCS to characterize these genes and monitor their effects on biochemical pathways,†said Steven Haney, Ph.D., associate fellow in biological profiling at Pfizer’s biotherapeutics and bioinnovation center. The company has invested heavily in developing cell models that are representative of human physiology, including hepatocytes that faithfully mimic liver function when grown in culture. The other main aspect of this research effort involves identifying changes that affect the diabetic phenotype, specifically glucose storage and utilization pathways, and distinguishing between effects that involve the insulin-signaling pathway from more general phenomena related to activation of toxicologic or stress pathways. “HCS can alert us to things we don’t necessarily know to look for, in a mechanism-independent way,†said Dr. Haney. “The increasing throughput of HCS allows us to look at a lot of cells and determine whether subtle phenotypic changes are significant or spurious.†Vendors Roll Out Image-Analysis SolutionsVersatility across application areas, from microscope-based imaging for detecting intracellular phenomena to high-speed scans at the cellular level to whole organism screening, is the focal point of instrument development at MDS Analytical Technologies. “With the options in our Complete Solution and the right infrastructure, you can use image-based assays for primary screening. We have tackled all the common bottlenecks,†said Michael Sjaastad, Ph.D., director of marketing for cellular imaging at MDS. The IsoCyte® DL laser-scanning cytometer complements the company’s ImageXpress® instrument platform as part of its overall HCS solution. MDS offers a high-throughput option that can screen and do image analysis on a 1,536-well plate in two to five minutes, according to Dr. Sjaastad. The instrument can image whole wells for accurate cell counting in cell-viability measurements, scan a microscope slide, or produce and analyze images of organisms such as zebrafish or worms when used in conjunction with the MetaXpress image-analysis software. For now, current systems “have the image resolution and acquisition speed researchers need,†and in Dr. Sjaastad’s view, future improvements will focus on “streamlining the data-analysis workflow and bringing the costs down per data point.†In a workshop at the meeting, Oliver Leven, Ph.D., head of screener professional services at Genedata, identified several ongoing challenges in HCS, including managing the volume and complexity of the data, improving the efficiency of data analysis, and creating an audit trail of results interpretation. As the throughput and scale of HCS increases, so too, do the difficulty and scope of these challenges. As researchers scale up an assay for high-throughput HCS, they need to select a defined set of parameters that represent the phenotype of interest and that allow them to assess the quality of both the assay and the data output. They also need to identify threshold values above or below which a result signifies a change in phenotype. The typical HCS image-analysis software that drives HCS systems routinely quantifies the cell images to yield a numerical description of the phenotypes. For large experiments, however, Dr. Leven described the researcher’s need to go back and view an image associated with an interesting or suspicious measurement as a persistent bottleneck. “The image is the experiment,†said Dr. Leven. A hit should signify a change in the cells, but it could also be an anecdotal finding or the result of an image out of focus. Distinguishing true hits from false positive results remains a challenge. Dr. Leven recounted the HCS projects that Genedata has performed for its pharma customers emphasizing the ability of the company’s High Content Analyzer—a new addition to the Genedata Screener® enterprise solution—to retrieve immediately any desired image. The high-throughput HCS projects described by Dr. Leven were able to analyze 40,000 compounds on a daily basis, for a total campaign of more than two million compounds, generating multifeatured data sets for each well. PerkinElmer’s high-content screening portfolio includes the Opera confocal microplate image reader and Acapellaâ„¢ image-analysis software, the compact Operetta HCS system, driven by Harmonyâ„¢ software, and the Columbusâ„¢ data-management system and new Columbus 2.0 for use with the Opera platform. Gabriele Gradl, Ph.D., global product leader for HCS at PerkinElmer Cellular Technologies, emphasized the complexity involved in deriving robust, quantitative data from cellular measurements derived on image analysis of high-content screens. Whereas, fluorescence-based analysis typically relies on identifying objects in cells and measuring their fluorescence intensities, PerkinElmer has developed a computational strategy that is independent of absolute fluorescence intensity. It relies on texture analysis and quantitative pattern analysis for data generation. Texture-analysis tools can detect patterns and effects that would not be apparent on routine visual analysis, according to Dr. Gradl. Threshold adjacency statistics is one example of such a tool. It searches for differences in fluorescence intensity values between adjacent pixels over a defined distance. Dr. Gradl described the particular advantages of applying texture analysis for detecting subtle morphologic changes associated with cell viability or toxicity assays and in stem cell research. It can detect differences not visible to the eye and identify changes that the user might not even have known to look for in the data. She presented, as an example, the use of texture analysis to assess mitochondrial integrity, as loss of mitochondrial activity and enhanced mitochondrial biogenesis are early markers of cytotoxicity. Dr. Gradl also described the use of texture analysis in brightfield imaging and the ability to assess segmentation based on granularity, enabling label-free proliferation assays and analysis of cell differentiation in real time. The algorithms developed by PerkinElmer can apply texture analysis to whole cells or to specific intracellular compartments depending on the design of the assay. The company is exploring a range of applications for its texture-analysis software tools, including stem cell differentiation analysis, quality control of stem cells produced for therapeutic use, live-cell imaging over time, and 3-D tissue sample analysis. Earlier this year, GE Healthcare introduced the IN Cell Analyzer 2000 cell-imaging system, which incorporates several new features: preview scoring of a selected area of a sample before an acquisition run; a large chip CCD camera coupled with a widefield illumination source for twice the brightness of a conventional xenon lamp, according to GE; whole-well imaging; an objectives range from 2x–100x; six imaging restoration modes; and a manual microscope mode. Fred Koller, Ph.D., president and CEO of Cyntellect, launched the company’s new Celigoâ„¢ cytometer at the “High Content East†meeting, emphasizing the system’s ability to image “every cell in every well,â€Â from edge to edge without edge effects using both brightfield and fluorescence imaging. Cyntellect’s optical technology achieves high-quality large field imaging using a set of mirrors to capture each well in its entirety without moving the plate and without the need to refocus, allowing for rapid, full-plate imaging. Celigo provides “uniform illumination with no gradient across the well,†said Dr. Koller, and allows for a combination of label-free imaging and three-color fluorescence. He described the instrument’s capabilities for performing cell-counting assays, cell growth tracking, and confluency studies, for example, and for noninvasive imaging of stem cell cultures without disrupting their three-dimensional colony structures. Celigo can switch from single-cell to colony-counting mode. The company has also developed a secretion assay for use on the Celigo that measures the amount of protein secreted by individual cells. The assay can distinguish between high and low secretors and is useful for detecting heterogeneity and instability in cell cultures early in process development, such as for antibody manufacturing. The Cellular Imaging and Analysis group at Thermo Fisher Scientific introduced the Cellomics iDevâ„¢ intelligent assay development workflow for HCS image analysis at “High Content Eastâ€. Users work training image sets of positive and negative biology, applying imaging and analytical algorithms that allow for real-time interaction with the images. The software employs the biological data generated to optimize assay protocols. Source: genengnews.com |
Posted under Compound Screening, Drug Development, HT Screening, Press Releases, Research Projects | No Comments
Evotec, Ono Extend Drug Discovery Services Pact
Last Updated on Tuesday, 1 December 2009 11:29 Written by Editor Tuesday, 1 December 2009 11:29
The companies began their drug target collaboration in March 2008.
Under the agreements, Evotec will provide high-throughput screening, in vitro pharmacology, protein crystallography, and medicinal chemistry services to discover small molecular weight compounds that will be used against an ion channel target. The aim of the collaboration is to move Ono’s compound towards clinical development.
For its research services, Evotec will receive research funding and milestone payments, the Hamburg-based company said.
“We anticipate the collaboration will result in identifying a novel drug candidate with a high potential,” Ono’s Managing Director, Kazuhito Kawabata, said in a statement.
Specific financial terms of the agreement were not released.
Posted under Collaborations, Compound Screening, Drug Development, Press Releases, Research Projects | No Comments
Agilux Laboratories Hires New Associate Director to Lead In Vitro ADMET Services Division
Last Updated on Thursday, 8 October 2009 12:22 Written by Editor Thursday, 8 October 2009 12:22
- Adrian Sheldon, Ph.D., Positions Contract Research Organization for Growth - WORCESTER, Mass.--(Business Wire)-- Agilux Laboratories, Inc., a Contract Research Organization (CRO) that provides bioanalytical and in vitro Absorption Distribution Metabolism Excretion Toxicology (ADMET) services for the biotechnology and pharmaceutical industries, has appointed Dr. Adrian Sheldon as associate director of In Vitro ADMET Services. In this role, Dr. Sheldon will build the In Vitro ADMET Services division offering testing services that allow biotechnology and pharmaceutical companies to screen drug candidates for desirable ADMET properties. Dr. Sheldon will leverage more than 17 years of industry experience, including establishing new business units for In Vitro ADMET and Immunochemistry within an established CRO. He will extend Agilux`s emphasis on customer service, rapid turnaround and exceptional data quality to the company`s newly formed In Vitro ADMET Services Testing Division. "We are excited to have someone with Adrian`s expertise, successful track record and demonstrated abilities at Agilux," said Jim Jersey, president and CEO at Agilux. "Adrian brings the right balance of scientific expertise and customer focus, which is consistent with Agilux`s mission of delivering high quality data at unprecedented speeds. We are confident that both the Agilux team and our clients will benefit from his unique skill set." Prior to Agilux, Dr. Sheldon served as associate director of In Vitro ADMET at Charles River Laboratories. Prior to Charles River Laboratories, Dr. Sheldon was group leader in Assay Development/HTS/In Vitro ADMET at ArQule where he co-managed a team responsible for screening compounds generated by the industry-leading combinatorial chemistry laboratory. He received his Ph.D. from Boston University and his A.B. from Harvard University. Dr. Sheldon has authored numerous scientific publications and holds two patents. "I am very pleased about joining the team at Agilux," stated Dr. Sheldon. "We have an incredible opportunity to change the way early stage development services are delivered and I am confident that I will be able to contribute to Agilux`s continuing success." About Agilux Laboratories, Inc. Agilux Laboratories, Inc. is a privately held contract research organization (CRO) focused on bioanlaytical and PK/PD testing services for the biotech and pharmaceutical industries. Leveraging industry and contract research experience of its management team, the company delivers high quality bioanlaytical chemistry and PK/PD data more rapidly. Agilux helps clients make better decisions during drug discovery and development by providing quality data earlier in the research process by using technologies and systems that increase turnaround speed well beyond industry standards. Founded in 2007 by industry experts Jim Jersey, Steve Guyan and Peter Glick, Agilux is headquartered in Worcester, MA and is funded by private equity firm, Ampersand Ventures. For more information, call 508-753-5000 or email sguyan@agiliuxlabs.com. Online at www.agiluxlabs.com. Agilux Laboratories, Inc. Steve Guyan Vice President, Sales and Marketing 508-762-4402 sguyan@agiluxlabs.com
Source: Reuters
Ore Pharmaceuticals Announces Upcoming Publication of Research Study on ORE1001
Last Updated on Thursday, 8 October 2009 12:19 Written by Editor Thursday, 8 October 2009 12:19
Ore Pharmaceuticals Inc. (Nasdaq:ORXE), announced today the publication of an article in the online version of the journal Inflammation Research titled, "Effects of the ACE2 inhibitor GL1001 on acute dextran sodium sulfate-induced colitis in mice." This article discussed the efficacy of Ore`s lead drug candidate, ORE1001 (formerly GL1001), in the dextran sodium sulfate animal screening model for inflammatory bowel disease drugs. The results show that treatment with ORE1001 displayed efficacy on par with that of the oral standard, sulphasalazine. ORE1001 improved common measures of the extent of damage, such as histopathology, in a dose-related and statistically significant manner. Moreover, ORE1001 markedly decreased tissue myeloperoxidase activity, a well-known marker of inflammation. The findings, when considered along with other studies of ORE1001, support further development of the compound in gastrointestinal inflammatory conditions. ORE1001 has progressed through multiple dose clinical phase I testing in the U.S. and is on track to commence a Phase Ib/IIa trial in ulcerative colitis, one of the two main disorders that comprise inflammatory bowel disease (IBD), in the second half of 2009. It is estimated that up to one million Americans are affected by IBD. With typical onset in childhood or early adulthood, these disorders cause many decades of pain and suffering and result in significant lost productivity, in addition to the direct costs of medical and surgical care. The burden on the U.S. healthcare system alone is significant; IBD is associated with health care costs estimated at more than $1.7 billion. Ore believes that ORE1001, if approved, could represent a significant enhancement to current therapies for treating this debilitating disease. The print article is expected to be published in an upcoming issue of Inflammation Research. The full text article is currently available online at: http://www.springer.com/birkhauser/biosciences/journal/11. Ore Pharmaceuticals Overview Ore Pharmaceuticals Inc. (the "Company") is a pharmaceutical asset management company. The Company acquires interests in pharmaceutical assets whose value, it believes, it can significantly enhance through targeted development, with the goal of then monetizing these assets through a sale or out-licensing. Initially, the Company will focus on developing and monetizing its current portfolio, which includes four clinical-stage compounds in-licensed from major pharmaceutical companies. The Company`s four compounds in its development portfolio are: ORE1001, its lead compound, ORE10002, ORE5002 (tiapamil) and ORE5007 (romazarit). Safe Harbor Statement This press release contains "forward-looking statements," as such term is used in the Securities Exchange Act of 1934, as amended. Such forward-looking statements include our ability to identify strategies for making its businesses successful and the impact of such strategies on our business and financial performance and on shareholder value. Forward-looking statements typically include the words "expect," "anticipate," "believe," "estimate," "intend," "may," "will," and similar expressions as they relate to Ore Pharmaceuticals or its management. Forward-looking statements are based on our current expectations and assumptions, which are subject to risks and uncertainties. They are not guarantees of our future performance or results. Our actual performance and results could differ materially from what we project in forward-looking statements for a variety of reasons and circumstances, including particularly risks and uncertainties that may affect the Company`s operations, financial condition and financial results and that are discussed in detail in the our Annual Report on Form 10-K and our other subsequent filings with the Securities and Exchange Commission. They include, but are not limited to: whether the compounds we develop will be commercially viable; whether we will be able to begin to generate sufficient new revenue from licensing or other transactions early enough to support our operations and continuing compound development; whether there will be valid claims for indemnification from the buyers of our Genomics Assets; whether there will be claims from the landlords of the leased properties we have assigned, the buyer of our Preclinical Division or the assignee of our Cambridge facility lease, that we would be required to pay as guarantors of such leases; whether we will be able to collect amounts due under the terms of promissory notes from the buyers of our Genomics Assets and molecular diagnostic business; whether we will be able to manage our existing cash adequately and whether we will have access to financing on sufficiently favorable terms to maintain our businesses and effect our strategies; whether we will be able to maintain our NASDAQ listing; whether we will be able to attract and retain qualified personnel for our business; and potential negative effects on our operations and financial results from workforce reductions and the transformation of our business. Ore Pharmaceuticals Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Ore Pharmaceuticals Inc. Benjamin L. Palleiko SVP & CFO 617-649-2001 bpalleiko@orepharma.com
Source: Reuters
Evotec Announces Research Agreement With Biogen Idec
Last Updated on Thursday, 8 October 2009 12:14 Written by Editor Thursday, 8 October 2009 12:14
HAMBURG, Germany and OXFORD, UK, Sept. 9, 2009 (GLOBE NEWSWIRE) -- Evotec AG (Frankfurt:EVT) (Nasdaq:EVTC), a leading provider in the discovery and development of novel small molecule drugs, today announced that it has entered into a research agreement with Biogen Idec (Nasdaq:BIIB), a leading biopharmaceutical company headquartered in Cambridge, Mass., USA. Evotec will use its expertise and technologies in protein production, assay development and high throughput screening to identify hit molecules for Biogen Idec. Under the research agreement Evotec will screen a target selected by Biogen Idec with the option to add further targets as agreed. Evotec will provide Biogen Idec with access to its full range of screening technologies and diverse library of high quality compounds and will use its expertise in protein production and assay development to develop new assays for the target. Dr. Mark Ashton, Evotec's EVP, Business Development commented: "We believe that the quality of future drug candidates is very much dependent on the identification of high quality starting points. To this end we have established a platform of screening technologies that have been proven to identify high-class hit molecules. We are looking forward to working with Biogen Idec and identifying interesting hit compounds for them." Evotec has built a comprehensive platform of hit finding technologies that allow it to screen challenging targets and identify new classes of hit compounds that can be progressed towards new treatments for various diseases. These proven screening technologies coupled with Evotec's high quality screening library have been shown to unlock numerous biological targets and identify excellent start points for subsequent optimization. No financial details are disclosed. About Evotec AG Evotec is a leader in the discovery and development of novel small molecule drugs. The Company has built substantial drug discovery expertise and an industrialized platform that can drive new innovative small molecule compounds into the clinic. In addition, Evotec has built a deep internal knowledge base in the treatment of diseases related to neuroscience, pain, and inflammation. Leveraging these skills and expertise the Company intends to develop best-in-class differentiated therapeutics and deliver superior science-driven discovery alliances with pharmaceutical and biotechnology companies. Evotec has long-term discovery alliances with partners including Boehringer Ingelheim, CHDI, Novartis, Ono Pharmaceutical and Roche. The Company has a P2X7 antagonist for the treatment of inflammatory diseases in clinical development and a series of preclinical compounds and development partnerships, including a strategic alliance with Roche for EVT 101, a subtype selective NMDA receptor antagonist, for use in treatment-resistant depression. For additional information please go to www.evotec.com Forward-looking statements Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. Such forward-looking statements include, but are not limited to, statements about our expectations and assumptions concerning regulatory, clinical and business strategies, the progress of our clinical development programs and timing of the results of our clinical trials, strategic collaborations and management's plans, objectives and strategies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things: risks that the Company may be unable to reduce its cash burn through recent restructuring and cost containment measures and may not recognize the results of such measures within the expected timeframe; risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured; the risk that we will not achieve the anticipated benefits of our collaborations, partnerships and acquisitions in the timeframes expected, or at all; risks relating to our ability to advance the development of product candidates currently in the pipeline or in clinical trials; our inability to further identify, develop and achieve commercial success for new products and technologies; the risk that competing products may be more successful; our inability to interest potential partners in our technologies and products; our inability to achieve commercial success for our products and technologies; our inability to protect our intellectual property and the cost of enforcing or defending our intellectual property rights; our failure to comply with regulations relating to our products and product candidates, including FDA requirements; the risk that the FDA may interpret the results of our studies differently than we have; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully secure regulatory approval of and market our drug candidates; and risks of new, changing and competitive technologies and regulations in the U.S. and internationally. The list of risks above is not exhaustive. Our most recent Annual Report on Form 20-F, filed with the Securities and Exchange Commission, and other documents filed with, or furnished to the Securities and Exchange Commission, contain additional factors that could impact our businesses and financial performance. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstance on which any such statement is based.
Source: Reuters
BioLeap Wins GlaxoSmithKline Contract to Design Novel Lead Compounds for Previously Intractable Targets for Important Unmet Medical Needs.
Last Updated on Wednesday, 9 September 2009 10:34 Written by Editor Wednesday, 9 September 2009 10:34
BioLeap and GSK have entered into an agreement whereby BioLeap will design novel lead compounds for "difficult" drug targets. The targets (not disclosed) are ones for which conventional approaches, like high throughput screening, have failed to yield a viable chemical starting point. Typically these are in areas of high unmet medical need. BioLeap will use its computational fragment-based drug design platform to conceive compounds de novo that are molecularly tailored to bind to the target. GSK will synthesize and test the compounds in biochemical and cellular assays. The process will iterate until GSK selects a Lead Candidate. The terms of the agreement for services were not disclosed. David Pompliano, PhD, CEO of BioLeap said, "We are very pleased to be working with GSK to accelerate the discovery of truly novel medicines. BioLeap`s platform reliably predicts the effect of compound modifications on target affinity, thus minimizing unproductive guesswork during drug discovery, and producing a better drug candidate more quickly." About BioLeap BioLeap is a leader in computational fragment-based drug design. The company`s proprietary design technology and process successfully addresses one of the biggest problems in pre-clinical drug discovery: the limitation of drug like and patentable leads for important biological targets. BioLeap is using its completely "in-silico" platform to quickly and accurately predict fragment-protein binding information that provides drug designers new insights that enable them to efficiently create new and improved drug molecule candidates. The BioLeap computational approach addresses the time, cost, and low probability of success limitations imposed by traditional library screening and lead optimization methods. BioLeap is utilizing its capabilities to advance its own internal preclinical stage programs while collaboratively enabling non-competing programs with numerous pharmaceutical partners.
Source: reuters.com
New Method Takes Aim At Aggressive Cancer Cells
Last Updated on Wednesday, 9 September 2009 10:32 Written by Editor Wednesday, 9 September 2009 10:32
A multi-institutional team of Boston-area researchers has discovered a chemical that works in mice to kill the rare but aggressive cells within breast cancers that have the ability to seed new tumors.
These cells, known as cancer stem cells, are thought to enable cancers to spread — and to reemerge after seemingly successful treatment. Although further work is needed to determine whether this specific chemical holds therapeutic promise for humans, the study shows that it is possible to find chemicals that selectively kill cancer
stem cells. The scientists’ findings appear in the August 13 advance online issue of Cell.
“Evidence is accumulating rapidly that cancer
stem cells are responsible for the aggressive powers of many
tumors,†says Robert Weinberg, a Member of Whitehead Institute for Biomedical Research and one of the authors of the study. “The ability to generate such cells in the laboratory, together with the powerful techniques available at the Broad Institute, made it possible to identify this chemical. There surely will be dozens of others with similar properties found over the next several years.â€
“Many therapies kill the bulk of a tumor only to see it regrow,†says Eric Lander, Director of the Broad Institute of MIT and Harvard, and an author of the Cell paper. “This raises the prospect of new kinds of anti-cancer therapies.â€
An emerging idea in cancer biology is that
tumors (breast, prostate, colon, lung, etc.) harbor a group of cells with the unique ability to regenerate cancers. In addition to promoting tumor growth, these so-called cancer
stem cells are largely resistant to current cancer therapies. If it were possible to identify chemicals that selectively kill cancer
stem cells, such chemicals might become critical candidates for future drug development.
However, researchers have struggled to study cancer
stem cells directly in the laboratory. The cells’ relative scarcity compared to other tumor cells, combined with a tendency to lose their stem cell-like properties when grown outside of the body, have severely limited the amount of material available for analysis.
To overcome these hurdles, Broad and Whitehead Institute researchers drew upon recent findings from Weinberg and his colleagues that suggested a way to generate in the laboratory large numbers of cancer cells with stem cell-like qualities. The technique works by coaxing adult cells to undergo a critical change (known as an “epithelial-to-mesenchymal transitionâ€) that alters their shape and motility. At the same time, the cells also adopt similar properties as
stem cells.
“A critical aspect of our work was to generate relatively homogenous and stable populations of cancer stem-like cells that could then be used for screening,†says Tamer Onder, a former graduate student in Weinberg’s lab and co-first author of the study. (Onder is now a postdoctoral
research fellow at Children’s Hospital in Boston.) “We were able to achieve this by inducing the cancer cells into an epithelial-to-mesenchymal transition using novel reagents that we had developed in the lab.â€
With an ample number of
stem cells in hand, the Broad-Whitehead team undertook a large-scale analysis of thousands of chemical compounds, applying automated methods to search for ones with activity against breast cancer
stem cells. From a pool of more than 30 promising candidates, the researchers identified a compound with surprising potency.
The compound, called
salinomycin, kills not only laboratory-created cancer
stem cells, but also naturally occurring ones. Compared to a common chemotherapeutic drug prescribed for breast cancer (known as paclitaxel),
salinomycin reduced the number of cancer
stem cells by more than 100-fold. It also diminished breast tumor growth in mice.
To further dissect the function of
salinomycin, the researchers also examined its genetic effects. Previous studies of
tumors from breast cancer patients have revealed groups of genes that are highly active in cancer
stem cells. Many of these same genes are linked with particularly aggressive
tumors and poor patient prognoses. The researchers’ studies show that salinomycin (but not paclitaxel) treatment can decrease the activity of these genes, revealing a possible molecular basis for the chemical’s biological effects.
“Our work reveals the biological effects of targeting cancer
stem cells,†says co-first author Piyush Gupta, a researcher at the Broad Institute. “Moreover, it suggests a general approach to finding novel anti-cancer therapies that can be applied to any solid tumor maintained by cancer
stem cells.â€
Although the new findings signal a noteworthy scientific milestone, it is still too early to know whether cancer patients will reap benefits from it. Additional
research is needed to determine exactly how
salinomycin works to kill cancer
stem cells and if it can wield the same tumor-reducing power in humans as it does in mice. These types of analyses generally take several years to complete.
But even with such tempered enthusiasm, there is also cause for optimism. In the current study, just 16,000 chemical compounds were tested, of which a small subset showed toxicity against cancer
stem cells. Therefore, deeper investigations of these compounds as well additional tests of broader collections of chemicals may yield other potential additions to the anti-cancer arsenal.
The path to new antibiotics
Last Updated on Monday, 31 August 2009 03:30 Written by Editor Monday, 31 August 2009 03:30
LA JOLLA, Calif., August 27, 2009 — Researchers at Burnham Institute for Medical Research (Burnham), University of Texas Southwestern Medical Center and University of Maryland have demonstrated that an enzyme that is essential to many bacteria can be targeted to kill dangerous pathogens. In addition, investigators discovered chemical compounds that can inhibit this enzyme and suppress the growth of pathogenic bacteria. These findings are essential to develop new broad-spectrum antibacterial agents to overcome multidrug resistance. The research was published in the Cell journal Chemistry & Biology on August 27.
Andrei Osterman, Ph.D., an associate professor in Burnham’s Bioinformatics and Systems Biology program, and colleagues, targeted the bacterial nicotinate mononucleotide adenylyltransferase (NadD), an essential enzyme for nicotinamide adenine dinculeotide (NAD) biosynthesis. NAD has many crucial functions in nearly all important pathogens and the bacterial NadD differs significantly from the human enzyme.
“It’s clear that because of bacterial resistance, we need new, wide-spectrum antibiotics,” said Dr. Osterman. “This enzyme is indispensable in many pathogens, so finding ways to inhibit it could give us new options against infection.”
According to the National Institutes of Health, drug resistance is making many diseases increasingly difficult — and sometimes impossible — to treat. They point to tuberculosis and methicillin-resistant Staphylococcus aureus (MRSA) as two pathogens that pose a serious threat to human health.
Using a structure-based approach, the team searched for low-molecular-weight compounds that would selectively inhibit bacterial NadD, but not the human equivalent, by screening, in silico, more than a million compounds. Experimental testing of the best predicted compounds against Escherichia coli and Bacillus anthracis (anthrax) led them to a handful of versatile inhibitory chemotypes, which they explored in detail. Using protein crystallography, a 3D structure of the enzyme in complex with one of the inhibitors was solved providing guidelines for further drug improvement.
“This is proof-of-concept that NadD is a good target to create antibacterial agents,” said Dr Osterman. “This knowledge will be useful for both biodefense and public health. The next step is to find better inhibitors. We do not have a silver bullet yet, but we are certainly hitting a golden target.”
This research was supported by a grant from the National Institute of Allergy and Infectious Diseases.
About Burnham Institute for Medical Research
Burnham Institute for Medical Research is dedicated to discovering the fundamental molecular causes of disease and devising the innovative therapies of tomorrow. Burnham, with operations in California and Florida, is one of the fastest-growing research institutes in the country. The institute ranks among the top four institutions nationally for NIH grant funding and among the top 25 organizations worldwide for its research impact. For the past decade (1999-2009), Burnham ranked first worldwide in the fields of biology and biochemistry for the impact of its research publications (defined by citations per publication), according to the Institute for Scientific Information.
Burnham utilizes a unique, collaborative approach to medical research and has established major research programs in cancer, neurodegeneration, diabetes, and infectious, inflammatory, and childhood diseases. The Institute is especially known for its world-class capabilities in stem cell research and drug discovery technologies. Burnham is a nonprofit public benefit corporation. For more information, please visit www.burnham.org.
Southern Research to Play Key Role in the Federal Government’s Search for New Cancer Therapies
Last Updated on Tuesday, 25 August 2009 03:29 Written by Editor Tuesday, 25 August 2009 03:29
National Cancer Institute Chemical Biology Consortium to coordinate academic, private and government cancer drug discovery efforts
BIRMINGHAM, Ala., Aug. 20 /PRNewswire-USNewswire/ — Southern Research Institute today announced that it has been selected as one of 11 organizations to help establish the National Cancer Institute’s (NCI) Chemical Biology Consortium (CBC)–a program meant to coordinate and accelerate the discovery and development of new therapeutic agents to treat cancer patients. Southern Research will establish one of NCI’s five Comprehensive Chemical Biology Centers at its Birmingham campus.
“We are very pleased that Southern Research was selected to participate in this new program to expedite and coordinate the discovery and development of new cancer therapies,” said W. Blaine Knight, Ph.D., vice president of Drug Discovery and Principal Investigator of this effort at Southern Research. “Cancer accounts for nearly one out of every four deaths in this country and the National Institutes of Health estimate that the overall costs of cancer last year were more than $228 billion for health expenses and lost productivity. The search for newer and better drugs is never-ending, and something cancer patients and their families depend upon.”
Southern Research has a remarkable cancer-fighting track record having already discovered six FDA-approved drugs currently used in the treatment of cancer–amifostine, fludarabine, dacarbazine, lomustine, carmustine and clofarabine–with seven additional drugs in late stage preclinical and early clinical trials. Scientists at Southern Research have also evaluated approximately 50 percent of all FDA-approved cancer drugs currently available for patients.
“Our experience in cancer research and our track record in drug discovery were clearly recognized by our selection as a Comprehensive Center in the CBC consortium,” said John A. Secrist III, Ph.D., president and CEO of Southern Research. “We look forward to partnering with the federal government as it accelerates cancer drug discovery.”
As a Comprehensive Chemical Biology Center, Southern Research will focus on numerous aspects of preclinical drug research from target discovery, assay development, high throughput screening, structural/computational chemistry, and biology, through lead optimization and preclinical development. In addition Southern Research has an extensive compound library that will be made available for the CBC effort.
Dr. Knight says that work is expected to begin immediately.
This project has been funded in whole or in part with Federal Funds from the National Cancer Institute, National Institutes of Health, under Contract No. NO1-CO-12400. The content of this publication does not necessarily reflect the views or policies of the Dept. of Health and Human Services, nor does the mention of trade names, commercial products or organizations imply endorsement by the U.S. Government.
About the Chemical Biology Consortium
The CBC will establish an integrated network of chemical biologists, molecular oncologists, and compound screening centers from government, academia, and eventually from industry. The drug discovery strategy of the CBC is to expand current NCI programs by providing a coordinated focus on therapeutic opportunities in high-risk, under-represented areas, significantly advancing the discovery of novel compounds active against specific molecular and genetic cancer targets. CBC efforts will include recruiting extramural investigators with specialized expertise in novel discovery platforms as well as medicinal chemistry, chemical biology, molecular oncology, and other areas of drug discovery and development. The CBC will be centrally managed to coordinate the selection of targets and screening for agents that interact with these targets, and will then use an iterative development process to design and optimize drug “hits” into “leads.” The CBC will benefit from access to the NCI’s late-stage drug development resources and expertise.
The program is being developed by NCI’s Division of Cancer Treatment and Diagnosis (DCTD), in conjunction with NCI’s Center for Cancer Research (CCR) and the NCI Director’s Office, with guidance from external advisory panels. This effort will be managed by the NCI’s Experimental Therapeutics (NExT) Program. SAIC-Frederick, Inc. (SAIC-F) will provide support for the key operational and technical aspects. It is envisioned that this Consortium will provide cutting-edge chemical tools for probing complex biochemical signaling pathways and will serve as the starting point for the elaboration of first-in-class targeted therapies. The long-term vision of the CBC is to bridge the gap between basic scientific findings and NCI-supported clinical research to facilitate the discovery and development of new agents to treat patients with cancer.
Participants will have an unparalleled opportunity to participate in a highly collaborative drug discovery partnership with the National Cancer Institute (NCI). Using state-of-the-art communication, data-sharing and project management tools, the CBC will effect a paradigm shift in the use of public-private partnerships to translate knowledge from leading academic institutions into ground-breaking new drug candidates for patients with cancer.
About Southern Research Institute
Southern Research Institute is a nonprofit 501(c)3 scientific research organization that conducts preclinical drug discovery and development, and advanced engineering research in materials, systems development, environment and energy. Our more than 550 scientific and engineering team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental and energy industries. Southern Research is headquartered in Birmingham, Ala., with facilities in Wilsonville, Ala., Anniston, Ala., Frederick, Md., and Durham, NC and offices in New Orleans, La., Washington, DC and Kiev, Ukraine. For more information about Southern Research and its capabilities and accomplishments, visit www.SouthernResearch.org.
Posted under Cancer Research, Grants and Awards, Press Releases, Research Projects | No Comments
Vanderbilt Joins National Consortium to Develop New Cancer Therapies
Last Updated on Tuesday, 25 August 2009 03:27 Written by Editor Tuesday, 25 August 2009 03:27
Vanderbilt University has been selected as one of 10 centers in the nation to participate in the Chemical Biology Consortium (CBC), a major new initiative to facilitate the discovery and development of new agents to treat cancer.
As one of four Chemical Diversity Centers, Vanderbilt’s role in the consortium will be to synthesize and optimize new compounds as potential cancer therapeutics.
“This is a real tribute to our growth in cancer chemistry and the leverage between the Vanderbilt Institute of Chemical Biology (VICB) and the Vanderbilt-Ingram Cancer Center (VICC),†said Lawrence Marnett, Ph.D., the Mary Geddes Stahlman Professor of Cancer Research and director of the VICB.
Alex Waterson, Ph.D., research assistant professor of Pharmacology and director of the VICB’s Chemical Synthesis Core, will lead efforts developing small molecule drug candidates. Gary Sulikowski, Ph.D., Stevenson Professor of Chemistry and a co-director of the core, will direct projects involving natural products.
Designed to accelerate the discovery and development of effective, first-in-class targeted therapies, the CBC will choose high-risk targets that are of low interest to the pharmaceutical industry. The CBC is a National Cancer Institute initiative administered by contractor SAIC-Frederick, Inc.
“It’s exciting in the sense that, right off the bat, (the NCI) said that the goal of this program is to develop drugs for cancer treatment,†said Sulikowski. “They’re looking for unique targets, unique approaches, and they think that academia may offer that.â€
“Oftentimes pharmaceutical companies will not go after targets that are not expected to be huge blockbusters,†said Waterson, who came to Vanderbilt in 2008 from GlaxoSmithKline where he had worked for seven years on oncology drug development projects. “So an effort like this can fill in a niche that industry is not taking on at the moment.â€
One particular area of interest is in screening and developing natural products as potential drug candidates.
This “is something that pharmaceutical industry has de-emphasized just because of the way things have evolved,†said Sulikowski. “And that’s one of our advantages, in that we have expertise in natural products as well as medicinal chemistry.â€
Cancer drug development poses many challenges – but also unique opportunities.
“There is a difficulty in that cancer is not a single disease; it’s a family of loosely related diseases,†said Waterson. “There’s an opportunity for a whole myriad of different treatments that are pretty much only tailored to a small subset of people, where your treatment addresses their specific need.â€
A unique aspect of the CBC is the NCI’s efforts to establish intellectual property rights for investigators and institutions that develop assays or drug candidates.
“The hope is that by recognizing establishment of intellectual property as one of the goals, they will attract people with the best ideas, things that really might be able to become a drug,†said Waterson.
Vanderbilt’s involvement with the CBC, along with the recent arrival of Stephen Fesik, Ph.D., who previously led cancer drug discovery efforts at Abbott Laboratories, will make Vanderbilt “one of the best academic institutions doing cancer drug discovery in the country,†Marnett said.
Other Vanderbilt investigators involved in this effort include:
• Brian Bachmann, Ph.D., assistant professor of Chemistry and Biochemistry
• Jeffrey Johnston, Ph.D., professor of Chemistry
• Jens Meiler, Ph.D., assistant professor of Chemistry, Pharmacology and Biomedical Informatics
• Craig Lindsley, Ph.D., associate professor of Pharmacology and Chemistry, and director of Medicinal Chemistry
Other sites participating in the CBC are:
• The Burnham Institute for Medical Research, in La Jolla, Calif.;
• Southern Research Institute in Birmingham, Ala.;
• University of North Carolina at Chapel Hill;
• Georgetown University in Washington, D.C.;
• University of Minnesota;
• University of Pittsburgh;
• University of Pittsburgh, Drug Discovery Institute;
• University of California, San Francisco;
• SRI International in Menlo Park, Calif.; and
• Emory University in Atlanta
This project has been funded in whole or in part with Federal Funds from the National Cancer Institute, National Institutes of Health, under Contract No. NO1-CO-12400. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.
Source:Â vanderbilt.edu
Posted under Cancer Research, Grants and Awards, Industry News, Press Releases, Research Projects | No Comments
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