Bio Screening Industry News

NOTTHINGHAM, England, May 31, 2005–One of Nottingham’s leading scientific experts is to address an international audience in Miami at the 32nd Annual Meeting of the Controlled Release Society from 18th-22nd June 2005.

Professor Ian Wilding, a founder and scientific adviser to early phase drug development success story Pharmaceutical Profiles, is very much in demand at this keynote conference. On the second day of the event, he will be presenting at a workshop entitled Using Scintigraphy to Visualize the in vivo Targeting Properties of Colonic Delivery Systems and giving a podium presentation focusing on University Spin-Out Companies - forget the lifestyle option and go for gold. Professor Wilding recently sold Pharmaceutical Profiles, a ’spin-out’ company from the University of Nottingham, for ? million, so has personal experience of translating academic excellence into commercial success. He is also chairing a conference session and on the last day of the conference is giving a keynote address Overcoming Developability Problems in Oral Drug Delivery Using Human Absorption and Scintigraphic Studies.

Prof. Wilding said: “The Controlled Release Society annual meeting is one of the first events we put in our corporate calendar - it is a must-attend event.”

“We are also taking part in the exhibition at CRS 2005 alongside my presentations in order to maximise the benefit of the event. It is an excellent opportunity to network with industry figures, learn about new drug delivery techniques and promote the unparalleled expertise Pharmaceutical Profiles has in early drug development.”

Pharmaceutical Profiles is a unique early phase contract research organization (CRO) which provides novel solutions in early clinical development. Since its inception in 1990, Pharmaceutical Profiles’ mission has been to improve the decision-making process by offering innovative services to the global pharmaceutical industry.

Around 30% of drug candidates fail to progress beyond Phase I healthy volunteer studies and these failures can be attributed mainly to inappropriate human biopharmaceutical properties. Human microdosing studies allow the administration of microgram quantities of drug candidates in man. This enables safer and more ethical screening studies in man prior to entering Phase I trials and the earlier selection of the optimal compound to advance in development. Human microdosing studies lead naturally into human drug absorption studies. Pharmaceutical Profiles utilizes the proprietary and patented Enterion(tm) capsule to effectively establish the optimal development strategy for today’s compounds with their complex oral biopharmaceutical properties.

Scientific expertise remains at the heart of Pharmaceutical Profiles. The company remains the world’s leading CRO resource for sophisticated medical imaging techniques, such as 2D gamma scintigraphy and 3D SPECT (Single Photon Emission Computed Tomography). These imaging modalities are incorporated into the oral scintigraphy and inhaled and nasal studies undertaken for the global pharmaceutical industry.

The company has its headquarters located in Ruddington near Nottingham, United Kingdom, and representative offices in the USA, and Japan. Further information on Pharmaceutical Profiles can be found at www.pharmprofiles.com

Researchers at the Burnham Institute found that a protein known for its role in gene regulation has another important function, that of initiating DNA repair.

The study has been published in Molecular Cell.

Ze’ev Ronai, director of the Institute’s Signal Transduction Program, and his colleagues found that the protein ATF2 ( Activating Transcription Factor-2 ) is activated by a protein kinase called ATM ( Ataxia-Telangiectasia Mutated ), which stimulates DNA repair.
ATF2’s role in regulating expression of proteins that control cell cycle and programmed cell death is well established.

The current study is the first to demonstrate ATF2’s role in DNA repair, an intracellular process that prevents formation of genetic mutations, including those that lead to cancer.

” This is the first time we’ve seen a protein which has been implicated in gene regulation possess an independent function–in DNA repair–while both functions are uncoupled from one another,” said Ronai.
Ronai’s laboratory has been studying ATF2 with the goal of understanding its role in regulation of cell cycle and programmed cell death.
These studies evolved from the finding that ATF2 has an important role in the development and progression of melanoma tumors.
Inhibition of ATF2 was found to sensitize melanoma to various treatments, both in tissue culture and in animal models.

” Melanoma is usually resistant to chemotherapy, but we found that by inhibiting ATF2, it became more sensitive to treatment,” Ronai said. Consequently, his laboratory developed a small peptide that interferes with ATF2 function, efficiently blocking melanoma growth in mouse models.

Ongoing studies are devoted to screening for compounds that mimic the peptide’s actions and to allow for further development of the peptide toward clinical assessment.

” Until our recent studies, we were certain that the mechanism by which ATF2 affects melanoma growth was primarily through its established function in the regulation of proteins important in cell cycle and cell death control. We were therefore most surprised to find an uncoupled function for the same protein,” said Ronai.

The finding of ATF2’s novel function in DNA repair was serendipitous.
As Shoichi Takahashi, a postgraduate researcher, was testing for the changes in ATF2 in human cancers, he ” lost the signal ” for ATF2. ” Later,” Ronai said, ” we did experiments that showed the signal was lost because a protein kinase, ATM, modified ATF2 enough to interfere with detection of the ATF2 signal.
Soon, work performed by Anindita Bhoumik confirmed that ATF2 is regulated by ATM and that this regulation is central to the cell’s ability to initiate DNA repair processes following ionizing irradiation or other exposures that cause breaks in DNA.
A likely way in which ATF2 works is to halt the cell’s cycle to allow repair of damaged DNA before such damage becomes permanent.”

Ronai and his colleagues are now determining how molecules like ATF2 can balance their dual roles. “High doses of radiation, as well as changes that take place in cancer and pathologic situations, can activate both functions of ATF2, which is expected to disturb the otherwise conserved balance between its role in gene regulation and the DNA damage response. We need to find out which of the two functions is more dominant under these circumstances in order to devise ways to regain the proper balance,” he said.

Source: Burnham Institute, 2005

A Burnham Institute study has found that a protein known for its role in gene regulation has another important function, that of initiating DNA repair. The study, published in the May 27th edition of Molecular Cell, points to new targets for treatment of cancer.

Ze’ev Ronai, Ph.D., Director of the Institute’s Signal Transduction Program, and his colleagues found that the protein ATF2 (”Activating Transcription Factor-2″) is activated by a protein kinase called ATM (”Ataxia-Telangiectasia Mutated), which stimulates DNA repair. ATF2’s role in regulating expression of proteins that control cell cycle and programmed cell death is well established. The current study is the first to demonstrate ATF2’s role in DNA repair, an intracellular process that prevents formation of genetic mutations, including those that lead to cancer.

“This is the first time we’ve seen a protein which has been implicated in gene regulation possess an independent function–in DNA repair–while both functions are uncoupled from one another,” said Ronai. Dr. Ronai’s laboratory has been studying ATF2 with the goal of understanding its role in regulation of cell cycle and programmed cell death. These studies evolved from the finding that ATF2 has an important role in the development and progression of melanoma tumors. Inhibition of ATF2 was found to sensitize melanoma to various treatments, both in tissue culture and in animal models.

“Melanoma is usually resistant to chemotherapy, but we found that by inhibiting ATF2, it became more sensitive to treatment,” Ronai said. Consequently, his laboratory developed a small peptide that interferes with ATF2 function, efficiently blocking melanoma growth in mouse models. Ongoing studies are devoted to screening for compounds that mimic the peptide’s actions and to allow for further development of the peptide toward clinical assessment.

“Until our recent studies, we were certain that the mechanism by which ATF2 affects melanoma growth was primarily through its established function in the regulation of proteins important in cell cycle and cell death control. We were therefore most surprised to find an uncoupled function for the same protein,” said Ronai.

The finding of ATF2’s novel function in DNA repair was serendipitous. As Shoichi Takahashi, a postgraduate researcher, was testing for the changes in ATF2 in human cancers, he “lost the signal” for ATF2. “Later,” Dr. Ronai said, “we did experiments that showed the signal was lost because a protein kinase, ATM, modified ATF2 enough to interfere with detection of the ATF2 signal. Soon, work performed by Anindita Bhoumik confirmed that ATF2 is regulated by ATM and that this regulation is central to the cell’s ability to initiate DNA repair processes following ionizing irradiation or other exposures that cause breaks in DNA. A likely way in which ATF2 works is to halt the cell’s cycle to allow repair of damaged DNA before such damage becomes permanent.”

Ronai and his colleagues are now determining how molecules like ATF2 can balance their dual roles. “High doses of radiation, as well as changes that take place in cancer and pathologic situations, can activate both functions of ATF2, which is expected to disturb the otherwise conserved balance between its role in gene regulation and the DNA damage response. We need to find out which of the two functions is more dominant under these circumstances in order to devise ways to regain the proper balance,” he said.

The Ronai lab’s work on ATF2 was started at Mount Sinai School of Medicine in New York City, from which Dr Ronai and his colleagues recently relocated to the Burnham Institute. This study was carried out in collaboration with Wolfgang Breitweiser and Nic Jones of the Paterson Institute for Cancer Research, Manchester, England, and Yosef Shiloh, of Tel Aviv University, Israel. The study was supported by a grant from the National Institutes of Health.

http://www.burnham.org

GRONINGEN and OSS, The Netherlands, May 25 /PRNewswire/ — Kiadis BV and
NV Organon announced today that both companies have entered into an
evaluation agreement centered around the use of Kiadis’ core on-line
screening technology, the BioSelact(TM), for the Reproductive Medicine
discovery program at Organon.
Under the terms of the collaboration, Organon will supply Kiadis with a
proprietary target. Financial details of the collaboration are not disclosed.
Kiadis will deliver Organon with novel active compounds against the target
utilizing its BioSelact(TM) technology. Organon is particularly interested in
the ability of Kiadis’ BioSelact(TM) technology to efficiently characterize
bioactive compounds present in complex chemical mixtures.
Ton Rijnders, Vice President Research Oss at Organon, said: “Organon has
selected the BioSelact(TM) technology because it may accelerate the discovery
programs by rapid on-line confirmation of new novel active compounds. This is
a great opportunity for Organon to evaluate the potential of the Kiadis
technology to identify new leads.”
Manja Bouman CEO of Kiadis, commented: “We are very pleased to start this
project together with Organon. We are excited and encouraged by the
confidence that Organon has shown by entering into this evaluation of
BioSelact(TM). This collaboration can be seen as a further validation of the
successful commercialization strategy of Kiadis and value of Kiadis’
technology.”
About Kiadis
Kiadis has developed the unique and proprietary BioSelact(TM) platform
technology, allowing for a revolutionary drug discovery approach which
greatly enhances lead discovery and optimization programs. The BioSelact(TM)
platform allows the highly efficient screening of every Compound source of
synthetic or natural origin on virtually all pharmaceutical target classes.
Kiadis has successfully applied its technology to pharmaceutical and
nutraceutical discovery programs.
About Organon
Organon - with shared head offices in Roseland, NJ, USA and Oss, The
Netherlands - creates, manufactures and markets prescription medicines that
improve the health and quality of human life. Through a combination of
independent growth and business partnerships, Organon strives to remain or
become one of the leading pharmaceutical companies in each of its core
therapeutic fields: reproductive medicine, psychiatry and anesthesia.
Organon products are sold in over 100 countries, of which more than 60
have an Organon subsidiary. Organon is the human health care business unit of
Akzo Nobel.
http://www.kiadis.com
http://www.organon.com

SOURCE Kiadis BV

By John Hallock
Bio-IT World

(05/24/05)—With the costs of populating drug pipelines rising sharply, drug companies are exploring new in vivo animal models to guide early pre-clinical drug development. Despite a plethora of available technologies to discern biological mechanisms, the relevance of such technologies is only as good as the physiological models to which they are applied. A complete picture of the biological interactions occurring in drug action and toxicity requires the examination of intact multicellular organisms.

One scientist leading the charge for emerging surrogate in vivo models in drug development is Randall Peterson, assistant professor of medicine at Massachusetts General Hospital and Harvard Medical School. After obtaining his Ph.D. from Harvard University in the laboratory of Stuart Schreiber, where he first demonstrated the feasibility of small-molecule screens in zebrafish, Peterson joined the lab of Mark Fishman (now the president of NIBR). Peterson is on the Scientific Advisory Board of Montigen Pharmaceuticals, and is a founder of Teleome Labs.

Peterson’s group is currently using zebrafish for an entirely new application: pre-clinical drug development. This zebrafish model is allowing phenotype-based discovery of lead compounds that can suppress disease phenotypes (see Nature Biotechnology, May 2004), as well as new approaches for testing compound safety. Bio-IT World contributor John Hallock spoke with Peterson about the key issues surrounding the use of in vivo surrogate models in drug development and drug safety.

more…

WALTHAM, Mass. (AP) — Praecis Pharmaceuticals Inc. said Friday it is cutting 60 percent of its 182-person work force and halting U.S. promotion of a prostate cancer treatment and development of a medication for Alzheimer’s disease.

The moves are part of a cost-cutting campaign that Praecis said will refocus its efforts “on its most promising assets.” Those include development of an oral compound for treatment of cancer and autoimmune diseases, and technology to aid drug discovery.

Praecis said it will reduce its work force to 75 employees, with about 100 workers losing their jobs immediately and a smaller number leaving in the coming months. The company said it will also consider relocating from its headquarters and research building in Waltham to a smaller facility.

The company said it is suspending U.S. promotion of its prostate cancer therapy Plenaxis and will work with the Food and Drug Administration to make the drug available to patients already on the therapy. Praecis will continue seeking approval to market the drug in Europe.

In December, Praecis said it was having continuing problems persuading U.S. doctors to prescribe Plenaxis, in part because of concerns about insurance reimbursement.

The company also said Friday it is suspending clinical trials for its Alzheimer’s treatment, called Apan.

“We believe that through these actions we have positioned the company for future success,” said Kevin McLaughlin, Praecis’ president and chief executive officer.

The company’s stock traded around $6 a share last spring but has since steadily declined.

Praecis shares rose 5 cents, or 7 percent, to close at 76 cents in Friday trading on the Nasdaq Stock Market, near the bottom of the stock’s 52-week range of 63 cents to $5.27.

OTTAWA, May 17 /CNW Telbec/ - PharmaGap Inc. (TSX-V: GAP) (”PharmaGap” or
“the Company”) today announced the formal completion of acute toxicity testing
in mice for its lead cancer drug, PhG alpha 1. Testing took place in Ottawa at
accredited facilities operated by the Institute of Biological Sciences, part
of the National Research Council of Canada, under the supervision of an
independent veterinarian. The drug was delivered to test groups of mice by
intravenous injection, orally and by direct application to the skin.
PharmaGap’s novel lead cancer drug, PhG alpha 1, is designed to
selectively target and inhibit the activity of Protein Kinase C alpha (PKC
alpha) in cancer cells. As verified by numerous researchers worldwide, there
is a clear link between the over-expression of PKC alpha and certain solid
tumours. In bench studies (in vitro) undertaken by PharmaGap researchers, PhG
alpha 1 has demonstrated effectiveness in controlling growth and killing
cancer cells that have aberrant levels of PKC alpha, including non-small cell
lung cancer, breast cancer (HER+) and neuroblastoma (a children’s cancer). The
drug also has shown effectiveness in reducing the effect of multi-drug
resistance arising from chemotherapy treatment on colon cancer cells.
Dr. Jennifer Arnold, the senior research scientist at PharmaGap
responsible for the tests, commented that: “We are very pleased with the
outcome of the acute toxicity studies. We were able to establish the toxic
dose and the efficacy dose maximum. The efficacy dose maximum is completely
lacking in deleterious side effects on behaviour and body weight and will
provide us with a broad and safe range for future efficacy studies”.
Robert McInnis, President and C.E.O. commented that: “These results
provide PharmaGap researchers with the necessary data to design the next
series of in vivo testing in mice, which will be to test for the effectiveness
of PhG alpha 1 in human cancer cells grown in mice. These efficacy studies are
anticipated to take place over the course of the summer. Completion of these
efficacy studies, along with the toxicity studies just completed, are a key
step in our discussions with large pharmaceutical companies who are
prospective licensees for PharmaGap compounds.”

About PharmaGap Inc.
——————–
PharmaGap Inc. (TSX-V: GAP), based in Ottawa, ON, a spin-off of the
National Research Council of Canada, is a biotechnology company with a core
focus developing novel therapeutic compounds for the treatment of cancer.
PharmaGap’s research platform targets the modulation of gap junction-mediated
intercellular communication by signaling pathways such as those controlled by
the Protein Kinase C isoforms. Based on its expertise in cell to cell
communication the Company has also developed innovative cell-based assays and
models designed for compound screening for drug development (ADMET) and for
immune-system profiling in animals and humans, and has developed an animal-
free skin cell growth medium.

SAN RAMON, Calif., May 17 /PRNewswire/ — Odyssey Thera, Inc. announced today an expanded agreement with Pfizer Inc. to profile compounds across Odyssey Thera’s panel of cell-based assays in order to characterize mechanism of action and pathway activity in human cells.

Odyssey Thera’s patented Protein-fragment Complementation Assay (PCA) technology measures pathway activity within living cells and is applied across signaling pathways relevant to drug discovery in key therapeutic areas. Odyssey Thera probes the intricate biochemical networks of living cells to identify on-target and off-pathway activities of drugs and lead compounds. The company has validated this approach in its Known and Unknown Drug Optimization Strategy (KUDOS) program, which analyzed the mechanism of action of known drugs and known toxicants across distinct signaling nodes in human cells.

The project with Pfizer will focus on 500 compounds from multiple therapeutic areas. “By screening compounds across our panel of assays, we can identify and eliminate unanticipated activity much earlier in the drug discovery and development process, before significant resources are invested in pre-clinical and clinical activities,” says Dr. John Westwick, Odyssey Thera’s Chief Scientific Officer. Financial terms of the agreement were not disclosed.

About Odyssey Thera

Odyssey Thera, Inc. is a privately held biotechnology company that utilizes a pathway-based approach to drug discovery in order to greatly improve the effectiveness and productivity of the drug development process. With an initial focus on anti-cancer agents, Odyssey Thera uses its proprietary Protein-fragment Complementation Assay (PCA) process and high throughput systems biology to improve the quality of information available about targets and lead compounds early in drug discovery and development. PCA combined with the use of living human cells instead of isolated proteins strengthens the predictive value of preclinical screening, significantly reducing the number of failures in drug discovery and improving pipelines and treatments for cancer and other diseases. For more information, please visit the company website at www.odysseythera.com.

Chelmsford’s Magellan Biosciences has acquired TekCel, a Hopkinton-based maker of sample-management and assay-automation systems for biomedical research. Terms of the transaction were not disclosed.

TekCel employs approximately 35 people, all of whom are expected to remain with the company, according to Magellan.

According to Robert J. Rosenthal, president and chief executive officer of Magellan, the acquisition of TekCel and its product line will allow the company to reach a market beyond the smaller enterprises.

Founded in 1998, TekCel’s modular, scalable family of products includes sample-management automation, liquid handling, software, and proprietary consumables addressing the researchers’ needs from archive compound storage through screening result.

Magellan Biosciences develops advanced instruments, automated systems, point-of-care products, and consumables for biomedical research and clinical diagnostics.

Boston Mass High Tech, MA

NAPLES, FL, May 12, 2005 - BioSpace, the leading online information source for the biotechnology and pharmaceutical industries, unveiled last night the 5th edition of the BioCapital Hotbed Campaign during a special reception at PharmaDiscovery 2005 Conference & Exhibition at the Washington, D.C. Convention Center.

2005 BioCapital Hotbed Map
http://www.biospace.com/hotbed/9/biocapital_map.cfm

2005 BioCapital Hotbed Homepage:
http://www.biospace.com/hotbed.cfm?RegionID=9

In addition to PharmaDiscovery 2005, BioSpace partnered with Maryland Biotechnology Association (MdBio), Northern Virginia Technology Council (NVTC), Technology Council of Maryland (TCM) and Virginia Biotechnology Association (VaBio) to promote and highlight the rich life science industry in the states of Delaware, Maryland, Virginia and Washington, D.C.

“We are pleased to be supporting BioSpace’s mission and the BioCapital campaign. BioCapital’s partnerships with professionals from within the biotechnology and pharmaceutical industries and PharmaDiscovery’s strong focus on the vital challenges affecting drug discovery productivity in those industries, makes for a unique and mutually beneficial relationship,” said Kevin Richards, Vice President, Life Sciences, Reed Exhibitions.

The 5th edition of BioCapital showcases a variety of biopharmaceutical companies located within the Mid-Atlantic region including AstraZeneca, Celera, Gene Logic and Wyeth. Other companies participating in the campaign include technology service providers PPD Development and Medifacts International. The BioCapital Hotbed map also highlights research institutes, non-profit organizations and universities within the area.

“BioSpace is grateful for all of the support we have received from the various organizations and members of the Mid-Atlantic life science community. We would also like to thank the participants of the 2005 campaign, especially PharmaDiscovery, who have made the 5th edition of BioCapital a huge success,” said Brian Vacanti, Division Manager, BioSpace.

The campaign features a BioCapital Hotbed Map, created by BioSpace’s professional artist, which displays the corporate logos and facilities of participating organizations. Copies of the map are available through BioSpace. The map is further enhanced through the integration of many functional components including a BioCapital Hotbed Homepage, on BioSpace’s industry leading Website, BioSpace.com.

The original 1985 Biotech Bay™ Map for the San Francisco Bay Area hangs on permanent display in the Smithsonian Institution’s National Museum of American History. BioCapital was first launched in 1996.

About BioSpace

BioSpace is globally recognized as the leading provider of web-based resources and information to the life science industry. For 20 years BioSpace has helped to accelerate communication and discovery among business and scientific leaders in the biopharmaceutical market. With a well-established site infrastructure and loyal online audience of over 1.5 million unique monthly visitors, BioSpace.com offers an unparalleled distribution channel for recruitment, investment, product, event and other life science industry messages.

BioSpace promotes and adds online functionality to distinct regional clusters of bioscience industry through their world renowned Hotbed Campaigns. Current campaigns include BioCorridor™, Biotech Bay™, BioGarden™, Pharm Country™ and others. Additionally, BioSpace offers an online life science career center, live career events and a clinical trials database, CCIS™.

BioSpace, a Career Innovations company, is headquartered in Naples, FL.

Related companies:

Accelovance, American Type Culture Collection, American University, Arkios BioDevelopment International, AstraZeneca Pharmaceuticals LP, Australian Trade Commission (Austrade), Baxter BioScience Corporation MD, BioSpace, Celera Genomics Group-an Applera Corp. Business, Delaware State University, EMINENT, Services Corporation, EntreMed Inc., Gene Logic Inc., George Washington University, Georgetown University, Human Genome Sciences Inc., Johns Hopkins University, Kforce Professional Staffing, MdBio Inc., Medifacts, International, MedImmune Inc., Montgomery College, New Jersey Biotechnology and Life Sciences Coalition, Northern Virginia Technology Council (NVTC), Otsuka America Pharmaceutical Inc., PPD Piedmont Research, Center, Quest Pharmaceutical Services, Reed Exhibition Companies, SAIC-Frederick Inc., Southern Research Institute, Tech Council of Maryland, Timtec Inc., Towson University, University of Baltimore, University of Delaware, University of Maryland, University of Virginia, Virginia Biotechnology Association, Virginia State University, Virginia Tech, Wyeth (Richmond VA)