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Researchers find candidates for new HIV drugs

Last Updated on Tuesday, 1 December 2009 11:26 Written by Editor Tuesday, 1 December 2009 11:26

While studying an HIV protein that plays an essential role in AIDS progression, researchers at the University of Pittsburgh School of Medicine have discovered compounds that show promise as novel treatments for the disease.

HIV drug discovery efforts have met with little success in finding compounds that interact with an important HIV virulence factor, called Nef, because it lacks biochemical activity that can be directly measured, explained Thomas E. Smithgall, Ph.D., William S. McEllroy Professor and Chair, Department of Microbiology and Molecular Genetics, and senior author of the paper, which was published last week in the early, online version of ACS Chemical Biology.

To get around that problem, Dr. Smithgall’s team developed an assay to measure Nef function indirectly by coupling it to another protein, called Hck, which Nef activates in HIV-infected cells. Because Hck activity can be easily measured, the investigators were able to use it as a reporter for Nef activity in an automated high-throughput screening process. In collaboration with the University of Pittsburgh Drug Discovery Institute, they screened a library of 10,000 chemical compounds against the coupled proteins to see which ones influenced Nef-induced activation of Hck.

After further testing, they confirmed that three compounds inhibited the activity of the Nef-Hck complex and, more importantly, all of them also interfered with HIV replication. One compound was so effective that it suppressed HIV replication to undetectable levels in cell culture experiments.

“So we now have a way to rapidly and efficiently screen for inhibitors of Nef signaling through Hck,” Dr. Smithgall said. “But the surprise was that some of those inhibitors also showed strong antiviral activity in cell culture models.”

There is evidence that people infected with HIV variants that have mutations in the Nef gene take substantially longer to develop disease symptoms or AIDS, he said. In animal models, disrupting the production of Nef from the virus or its interaction with Hck also delays or prevents disease symptoms. The next challenge for the researchers will be to determine whether these compounds also interfere with progression of AIDS-like disease in animal models by blocking Nef function.

“Most current therapies for HIV infection use drugs that interfere with the function of viral enzymes such as reverse transcriptase or with the interaction of the virus and the host cell,” Dr. Smithgall said. “Targeting Nef represents an entirely new approach that could be useful to deal with issues such as drug-resistant HIV strains, and may slow the progression to AIDS.”

He added that Nef is just one of several so-called “accessory proteins” encoded by HIV which are important virulence factors in AIDS. Inhibitory compounds against some of the others might be revealed using a similar coupled protein approach for high throughput screening.

Source: labspaces.net

Posted under Compound Screening, Discoveries, Innovations and Patents, Drug Development, HIV Research, HT Screening, New Drugs, Press Releases  |  Comments Off

AIDS Study Flushes Out Hidden Virus, Pointing to Possible Cure

Last Updated on Wednesday, 14 October 2009 10:02 Written by Editor Wednesday, 14 October 2009 10:02

Oct. 2 (Bloomberg) — Scientists, moving closer to a cure for AIDS, identified a way to find medicines that would help rid patients of the hardest-to-treat pockets of HIV.

Current anti-HIV drugs reduce the virus to undetectable levels without eradicating it. The virus survives by lying dormant in immune-system cells, where the medicines don’t reach them. Scientists from Johns Hopkins University and the Howard Hughes Medical Institute reported yesterday that they developed a way of luring out these cells in laboratory experiments, an achievement they said may lead to a cure if repeated in humans.

In 2007, about 2.7 million people were newly infected with HIV, the virus that causes AIDS, and 2 million died of the disease, making it the world’s deadliest infectious malady, according to the Geneva-based World Health Organization, an arm of the United Nations. Scientists looking to stop HIV have turned to attacking so-called latent reservoirs of the virus after efforts to prevent infection, such as vaccines and gels, largely failed.

“This is a way in which you could envision finding a drug that would, in conjunction with existing treatment, allow us to cure patients,” said Robert Siliciano, the professor who led the study at Johns Hopkins’s medical school in Baltimore. More research is needed, he said.

For about 12 years, doctors have known that HIV, or human immunodeficiency virus, can lie dormant in immune-system cells called resting CD4s found in the lymph nodes, spleen and blood. There the virus stops replicating, avoiding the drugs designed to kill it.

Roaring Back

Studies have shown latent HIV comes roaring back when treatment is interrupted, condemning patients to a lifetime on drugs such as Abbott Laboratories’ Kaletra that can cause side effects including nausea, liver damage and fat buildup. Eliminating the last vestiges of the virus could cure patients of the disease, allowing them to stop treatment.

Siliciano’s team mimicked HIV latency in a lab dish using a gene called Bcl-2 to turn normal CD4s into resting cells capable of hosting the dormant form of HIV.

The researchers used the model to test 2,400 chemicals, finding 17 that coaxed the virus out of hiding, kick-starting its normal process of replication. In a human, that would make the virus susceptible to drugs. The best performer was a compound called 5HN found in the leaves, bark and roots of the black walnut tree.

‘Key Thing’

“They’ve found a way to find drugs — that’s the key thing,” said Stephen Kent, a professor of immunology at the University of Melbourne, in a telephone interview yesterday. “We’ve really just been guessing up to this point about ways to get at this. Having a system for screening drugs is a big advance over what we’ve had so far.”

The result was achieved without rousing non-infected CD4 cells, avoiding a potentially fatal scenario called a cytokine storm in which the body’s immune system overreacts.

The study has limitations, Siliciano said. First, 5HN may be too toxic for use in humans, he said by phone.

“It’s going to require additional research to find something that does the same thing but doesn’t have lots of other effects,” Siliciano said. “We’re pretty confident that we’ll find lots of compounds that work, but whether any of those will be sufficiently free of other effects — that’s not clear,” he said.

Second, recent studies have pointed to another reservoir of latent HIV that has yet to be identified, Siliciano said.

No Test

“We may have to find another drug to target that reservoir,” he said. “First we have to identify what it is.”

There’s no test for identifying whether a patient has latent HIV, meaning the only way to be sure a drug has polished off the virus is to cease treatment and see if it returns, the University of Melbourne’s Kent said.

The findings are an advance that may allow researchers to come up with a drug they could start testing in humans, Kent said.

“To get something like that into clinical trials is only a few short years — it’s not decades,” he said. “Then it’s got to work.”

The study was published yesterday in the Journal of Clinical Investigation, a peer-reviewed journal published by the American Society for Clinical Investigation, of Ann Arbor, Michigan.

The research was funded by the National Institutes of Health in Bethesda, Maryland; the Doris Duke Charitable Foundation in New York; and the Howard Hughes Medical Institute in Chevy Chase, Maryland.

To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net

Source: bloomberg.com

Posted under Discoveries, Innovations and Patents, HIV Research, New Drugs, Press Releases  |  Comments Off

Sirona Biochem Optimizes Key Test for Diabetes and Obesity Drug Development

Last Updated on Friday, 21 August 2009 01:26 Written by Editor Friday, 21 August 2009 01:26

VANCOUVER, BC — (Marketwire) — 07/16/09 — Sirona Biochem Corp. (TSX-V: SBM) announced today it is now ready to begin testing its novel new compounds to fight diabetes and obesity.

The completion of the company’s key SGLT biological assessment test and testing will be done under contract with Richmond, BC based SignalChem.

Sirona Biochem owns the worldwide rights to a library of potential new sodium glucose transporter (SGLT) inhibitors developed to treat diabetes and obesity. SGLT Inhibitors are a novel new drug class currently under development that block the reuptake of excess sugars from urine in the kidney which can then reduce high blood sugar to normal levels. Excess sugar in the blood is a primary medical challenge associated with treating diabetes and obesity.

Sirona has a research and development agreement with TFChem (Rouen, France), where a significant number of SGLT drug analogs are being prepared for first stage evaluation. Preliminary primary stage testing conducted earlier this year provided positive indications to support Sirona Biochem’s project and provided key insights to optimize the new test that is now ready for use to evaluate the next library set of molecules.

Mark Senner, President, explained, “SGLT inhibitors are a new and exciting class of compounds that have great promise to treat both diabetes and obesity which are now at epidemic levels worldwide. This new drug class is one considered to have extraordinary market potential in the fight against diabetes and obesity.

“Development of this new drug class however is challenging due to the fragile nature of these ‘sugar’ based molecules that render them unstable and difficult to develop for clinical use. Given this challenge, it is believed that the use of the patented GlycoMim® technology, licensed from TFChem to develop SGLT Inhibitors, will increase drug stability and, therefore, improve their overall clinical effectiveness. Potential licensing and development partners have expressed interest in our concept of improving molecules in this new drug class. We intend to develop ‘best in class’ SGLT Inhibitors through use of this technology.

“The key and critical first test has been developed and optimized for use by SignalChem under contract from Sirona Biochem. Through use of this proprietary test, the company will be able to determine which molecules have the desired potency and selectivity compared to a reference standard. Screening of the current library of compounds will generate key data for ongoing drug development and provide first stage proof of concept necessary to secure future partnering opportunities. Sirona’s scientific team aims to identify lead compounds by the end of 2009,” continued Senner.

“The results from our new optimized test will be critical to direct our ongoing development of novel new SGLT inhibitors. The development and optimization of this sophisticated test, completed by SignalChem, is a significant and key milestone achievement for us. We are very pleased with the progress that we are making on our SGLT drug development program,” commented Senner.

Upon selection of compounds with the desired potency and selectivity for the SGLT 2 carrier protein, further preclinical screening for cytotoxicity, ADME properties, pharmacokinetics and in vivo efficacy will need to be carried out to select compounds for future clinical development. The primary objective of this critical first stage development plan with SignalChem was to develop, qualify and optimize the key test required for the initial development of SGLT inhibitors.

Investors are invited to visit the Sirona Biochem website at: http://www.sironabiochem.com where we feature the most recent information about the company and its activities. Alternatively, investors are able to e-mail all questions and correspondence to info@sironabiochem.com where they can also request to be added to the investor e-mail list to receive all future press releases and updates or call John Dougherty, Corporate Development at 604-641-4466.

About the Company:

Sirona Biochem Corp. (TSX-V: SBM) is a emerging biotech company dedicated to the discovery and development of novel drug compounds. The current focus is on treatments for Type II Diabetes and Obesity. Sirona has entered into a license agreement with TFChem S.A.R.L., a Drug Discovery company based in Rouen, France. TFChem licenses its technology of fluorinated carbohydrate mimics: GlycoMim®, and products in development to biotech companies. The license agreement with TFChem provides for research and development of new compounds known as S.G.L.T. inhibitors. S.G.L.T. inhibitors are a new and exciting class of compounds that have great promise and potential to treat both diabetes and obesity.

About SignalChem:

SignalChem, based in Richmond, B.C., Canada is a biotechnology company focused on the research, development and production of innovative cell signaling products to advance basic research and drug discovery efforts, with specific emphasis on the production of highly purified biologically active human recombinant proteins. SignalChem is emerging as a leader and a key contender in the life science recombinant protein market place. SignalChem offers a comprehensive discovery service which includes: gene cloning & expression of therapeutic ‘targets,’ custom assay & antibody development and compound profiling for drug ‘potency’ & ‘selectivity.’

Mark Senner
President and Director

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Sirona Biochem
950-789 West Pender Street
Vancouver, B.C., V6C 1H2
Direct: 604-641-4466
Fax: 604-608-5471
info@sironabiochem.com

Source: www.sys-con.com

Posted under Compound Screening, New Drugs, North America, Press Releases, USA and Canada  |  Comments Off

CytRx Unveils Clinical Development Plan for Pipeline Assets

Last Updated on Friday, 12 December 2008 02:47 Written by Editor Friday, 12 December 2008 02:47

Names World-Renowned Cancer Drug Expert Dr. Joseph Rubinfeld as Chief Scientific Advisor

LOS ANGELES–(BUSINESS WIRE)–CytRx Corporation (NASDAQ: CYTR) today unveiled its corporate strategy to focus its internal resources on the clinical development of oncology drug candidates tamibarotene and INNO-206, which the Company believes offer the greatest mix of near-term and medium-term revenue potential among its clinical assets. CytRx will pursue partnerships to advance the clinical development of INNO-406 (bafetinib) and its clinical molecular chaperone portfolio, where it continues to see significant future revenue potential. The Company further intends to use its proprietary high-throughput, high-content drug screening Master Chaperone Regulator Assay (MaCRA) platform to discover additional molecular chaperone drug candidates, including those that may inhibit cancer growth, which will support internal efforts to build an oncology drug franchise or future out-licensing possibilities.

CytRx also announced that Board of Directors’ member Dr. Joseph Rubinfeld has accepted the additional responsibility of Chief Scientific Advisor, and will consult on all aspects of the Company’s oncology development programs while serving as an important interface between the Company and investors, clinicians and industry thought leaders. Dr. Rubinfeld brings substantial expertise in oncology and drug development through his distinguished career. Dr. Rubinfeld was employed at Bristol-Myers Company International Division as Vice President and Director of Research and Development. While at Bristol-Myers, Dr. Rubinfeld was instrumental in licensing the original anticancer line of products, including Mitomycin and Bleomycin. Among other accomplishments, he was among the four co-founders of Amgen, Inc., and founded SuperGen, Inc., where he previously served as CEO, President and Chief Scientific Officer. In his career he has been instrumental in the development of several blockbuster cancer drugs including cisplatinum, etoposide, erythropoietin, decibitene and pentostatin, and the antibiotics amoxicillin and cefadroxil.

Steven A. Kriegsman, CytRx President and CEO said, “We feel that our stockholders are best served by a focus on potential therapeutics for cancer. We believe tamibarotene has strong potential as a revenue generator with a high likelihood for rapid U.S. approval as a third-line treatment for acute promyelocytic leukemia (APL). Our view is based on the substantial clinical history of tamibarotene as an approved treatment of relapsed APL, in Japan and the existing special protocol assessment (SPA) in place with the U.S. Food and Drug Administration (FDA) for our ongoing U.S. registration clinical trial. We are accelerating enrollment in this clinical trial, with the expectation of filing an NDA with the FDA as early as 2010. We are also taking steps to move into a Phase 2 clinical trial with INNO-206, our highly promising targetable pro-drug for the commonly prescribed chemotherapeutic doxorubicin. We believe that INNO-206 could be effective in a wide variety of cancers, including small cell lung cancer, sarcoma, breast and ovarian cancer and Non-Hodgkins Lymphoma.

“Importantly, we expect that we have ample financial resources with our current cash position and investment in RXi Pharmaceuticals Corporation to support this strategy,” according to Mr. Kriegsman. “We have strong oncology expertise within CytRx and are delighted that Dr. Joseph Rubinfeld, our long-time board member who has enjoyed an illustrious career developing cancer drugs, will be taking a leadership role in our oncology programs.”

Dr. Rubinfeld said, “Having reviewed the extensive data on tamibarotene and INNO-206, I am excited about the potential for these two cancer drug candidates and look forward to working closely with the CytRx management team to advance their clinical development to potential commercialization. I am also encouraged by the Phase 1 data we announced earlier this month with INNO-406, now known as bafetinib, which demonstrated positive, clinical responses in 35% of patients with refractory chronic myeloid leukemia. I believe these results will be instrumental in our search for a partnership for bafetinib.”

Mr. Kriegsman added, “We also stand behind our view that our orally administered molecular chaperone drug candidates, arimoclomol and iroxanadine, provide enormous potential in addressing large, underserved markets and are convinced that the prudent course to maximize stockholder value in this economic climate is to pursue pharmaceutical partners to share additional development costs for these longer-term programs. We intend to complete our ongoing arimoclomol animal toxicology studies and work aggressively toward lifting the current clinical hold in order to enable this drug candidate to move back into the clinic. At that point, we will seek partners for further development of arimoclomol as a therapeutic treatment for both ALS and stroke recovery. Additionally, iroxanadine has shown significant potential as a therapeutic treatment for diabetic foot ulcers and other diabetic complications, and based on Phase 2 data, we will pursue potential partnerships in cardiovascular conditions.”

CytRx’s drug portfolio includes the following:

Oncology Drug Candidates:

Tamibarotene: CytRx holds the North American and European rights to tamibarotene, a rationally designed, synthetic retinoid compound designed to potentially avoid toxic side effects of the current first-line APL treatment trans-retinoic acid (ATRA). CytRx is actively enrolling patients in a Phase 2 registration clinical trial, known as STAR-1, with tamibarotene to evaluate its efficacy and safety as a third-line treatment for APL. The registration study is being conducted under a Special Protocol Assessment. The FDA has granted Orphan Drug Designation and Fast Track Designation for the use of tamibarotene in patients with relapsed or refractory APL following treatment with ATRA and arsenic trioxide.

There are currently no approved third-line treatment options for refractory APL patients. CytRx estimates the U.S. market opportunity for tamibarotene in refractory APL at approximately $20 million annually. CytRx scientists are also evaluating clinical strategies for developing tamibarotene as a first-line or second-line APL therapy. The estimated annual market potential in the U.S. and Europe for an expanded label including refractory, maintenance and front-line therapy is $150 million. CytRx also retains an option to expand its licenses for the use of tamibarotene in other cancers including multiple myeloma, myelodysplastic syndrome and certain solid tumors in the U.S., and multiple myeloma, myelodysplastic syndrome and solid tumors, other than hepatocellular carcinoma, in Europe.

INNO-206: This pro-drug derivative of the commonly prescribed chemotherapeutic agent doxorubicin is designed to reduce adverse events by controlling drug release and preferentially targeting the tumor. In a Phase 1 study, INNO-206 was administered in doses at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. Objective clinical responses were seen in patients with sarcoma, breast and lung cancers. The Company plans to evaluate further clinical development of INNO-206 in a wide variety of cancers, including sarcomas, breast and ovarian cancer, and Non-Hodgkins Lymphoma.

INNO-406 (bafetinib): INNO-406 (bafetinib), a potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor, is being evaluated for the treatment of patients with chronic myeloid leukemia (CML) and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to imatinib (Gleevec®) and second-line tyrosine kinase inhibitors (i.e. dasatinib (Sprycel®) and nilotinib (Tasigna®)). In November 2008, CytRx announced that bafetinib demonstrated positive, clinical responses in 35% of patients with CML in Phase 1 clinical testing. The Phase 1 clinical trial was used to determine the optimal dose prior to Phase 2 clinical efficacy testing.

CML is a type of cancer that starts in blood-forming cells of the bone marrow and invades the blood. In 2007, the American Cancer Society estimated that approximately 4,600 new cases of CML were diagnosed in the U.S. and that the number will increase as the population ages. Current estimates are that worldwide CML prevalence will increase by 10,000 patients a year, reaching a population of 110,000 in 2010. The global market will grow to an estimated $5.5 billion by 2012.

Molecular Chaperone Regulation

CytRx is a leader in molecular chaperone regulation technology. The Company currently has two orally administered, clinical-stage, drug candidates and recently discovered a series of additional compounds that may provide a pipeline for additional drug candidates. The Company’s drug candidates are believed to function by regulating a normal cellular protein repair pathway through the activation or inhibition of “molecular chaperones.” Because damaged proteins are thought to play a role in many diseases, activation of molecular chaperones that help to reduce the accumulation of misfolded proteins may have therapeutic efficacy in a broad range of disease states. Similarly, CytRx believes that the inhibition of molecular chaperones that normally help protect cancer cells from toxic misfolded proteins may result in the selective destruction of cancer cells.

  • Arimoclomol: This molecular chaperone regulator drug candidate is being considered as a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) and stroke recovery. Arimoclomol has been studied in seven Phase 1 and two Phase 2 clinical trials without any significant adverse events. CytRx’s Phase 2b clinical trial with arimoclomol as a treatment for ALS was placed on clinical hold by the FDA in January 2008, unrelated to any data generated by human studies, and additional preclinical toxicology studies are underway to resolve this issue.
  • Iroxanadine: CytRx believes that this orally available small molecule compound represents a potentially powerful breakthrough in the treatment of vascular diseases that are caused in part by damage to “vascular endothelium” that lines the inside of blood vessels. CytRx believes that endothelial dysfunction plays a key role in the development of various vascular diseases or their complications including diabetic ulcers, thrombosis, retinopathy, and peripheral artery disease. Preclinical and clinical studies with iroxanadine indicate that it has therapeutic potential for the treatment of cardiovascular atherosclerosis. According to the National Heart, Lung & Blood Institute, atherosclerosis is a leading cause of illness and death in the U.S. and affects approximately 4.6 million people annually.

CytRx San Diego Laboratory: The CytRx San Diego Laboratory is using the Company’s proprietary Master Chaperone Regulator Assay (MaCRA), a cell image-based screening tool that enables the rapid and quantifiable screening of large numbers of small molecule compounds. This technology is used to identify potential drug candidates that modify the activity of a protein known as heat shock transcription factor 1 (Hsf1) and consequently control entire groups of molecular chaperone proteins that repair or degrade toxic misfolded proteins present in diseased cells. Evaluation of the compounds identified in the screen has shown that they exhibit cytoprotective properties in cell culture models of disease. This platform has broad applicability to a range of therapeutic areas, through its ability to identify drug candidates that can either inhibit or amplify molecular chaperone activity. Information related to the development of MaCRA for compound screening was published in the November 2008 issue of the peer-reviewed Journal of Biomolecular Screening.

CytRx Oncology Expertise

Collectively, CytRx’s management and its Board of Directors have brought numerous cancer drugs to market. In addition to Dr. Rubinfeld, the senior managers and directors of CytRx who hold significant oncology experience include: Max Link, Ph.D., Chairman of the Company’s Board of Directors since 1996, who served for a number of years as Chairman and CEO of Sandoz Pharma as well as a director of Alexion Pharmaceuticals, Inc., Celsion Corporation and Discovery Laboratories, Inc.; Jack R. Barber, Ph.D., Chief Scientific Officer, who has significant R&D experience in oncology at Immusol and Viagene, where he most recently served as Head of Oncology; and Shi Chung Ng, Ph.D., Senior Vice President of Research and Development, who has substantial R&D experience at companies such as Abbott and ArQule, Inc., and most recently served as Vice President of Molecular Oncology at Ligand Pharmaceuticals.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx drug development pipeline includes programs in clinical development for cancer indications, including tamibarotene in a registration study for the treatment of acute promyelocytic leukemia (APL). CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. The Company owns and operates a research and development facility in San Diego. CytRx also maintains a 45% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ: RXII). For more information on the Company, visit www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome or results of any pre-clinical or clinical testing of CytRx’s potential oncology or molecular chaperone drug candidates, including tamibarotene as a third-line treatment for APL, risks related to CytRx’s ability to enter into partnerships to advance the clinical development of INNO-406 and its clinical molecular chaperone portfolio, uncertainties related to the impact of the FDA’s clinical hold on the Company’s arimoclomol clinical trial for ALS on the timing and ability to resume clinical testing at the desired dosage of arimoclomol, the risk that any requirements imposed on the Company’s planned clinical trial designs for ALS or stroke recovery by the FDA as a result of the concerns expressed in their clinical hold of the Company’s ALS program might adversely affect the Company’s ability to demonstrate that arimoclomol is efficacious in treating ALS or stroke patients or cause the Company to cancel one or both of those trials, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, risks related to the future market value of CytRx’s investment in RXi and the liquidity of that investment, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Posted under Cancer Research, Clinical Trials, Compound Screening, Discoveries, Innovations and Patents, Drug Development, FDA News, Medicinal Chemistry, New Drugs, New Products, North America, Oncology Research, Press Releases, R & D, Research Projects, USA and Canada  |  Comments Off

MorphoSys and Galapagos Enter Alliance to Co-develop Novel Therapeutic Antibodies in Bone and Joint Disease

Last Updated on Monday, 1 December 2008 12:59 Written by Editor Monday, 1 December 2008 12:59


Combination of Proprietary Drug Targets and Unique Technologies to Create Range of New Therapeutic Antibodies

MUNICH, GERMANY — (Marketwire) — 11/26/08 — MorphoSys AG (FSE: MOR; Prime StandardSegment, TecDAX) and Galapagos NV (Euronext: GLPG) announced today the launch of a long term co-development alliance aimed at discovering and developing antibody therapies based on novel modes of action in bone and joint disease, including rheumatoid arthritis, osteoporosis and osteoarthritis.

The alliance spans all activities from target discovery through to completion of proof of concept clinical trials of novel therapeutic antibodies. Both companies will contribute their core technologies and expertise to the alliance. Galapagos will provide antibody targetsimplicated in bone and joint disease in addition to its adenoviral target discovery platform to discover further targets for antibody development.MorphoSys will contribute its HuCAL antibody technologies to generate fully human antibodies directed against these targets. The initial goal is to further validate the targets through disease-specific in vitro and in vivotesting of the antibodies. After successful validation, the alliance will select antibody programs for pre-clinical and clinical development.Following proof of concept in human clinical trials, programs will be partnered for subsequent development, approval and marketing.

Under the terms of the agreement, Galapagos and MorphoSys will share the research and development costs, as well as all future revenues equally.Decisions will be made by a Joint Steering Committee comprising members of both companies. An initial set of three targets implicated in bone and joint disease has been selected for the collaboration, and Galapagos isalready commencing with production of these proteins for the alliance.Generation of antibodies directed against these targets will start in2009. More targets will be selected using Galapagos’ target discovery platform to fuel the alliance in the coming years. If successful, the first antibody programs based on these novel targets could enter the clinic within four to five years.

“With this alliance, we are adding a biologics strategy to our small molecule drug discovery. Galapagos is the world leader in discovery ofnovel targets, and this alliance with MorphoSys enables us to explore the potential of proprietary antibody targets. Antibody approaches have provento be successful in developing new therapies for major diseases, including rheumatoid arthritis. Having both approaches, small molecules andantibodies, to fill our product pipeline in bone and joint disease willfurther establish Galapagos as the leader in this field,” said Onno van deStolpe, Chief Executive Officer of Galapagos. “With our cash position and revenue streams from both BioFocus DPI and our pharma alliances, we are in a good financial position to enter into this alliance to create value for our shareholders.”

“This alliance represents a major step in our efforts to gain access to novel antibody targets for proprietary drug development in disease areas with a high unmet medical need. The partnership with Galapagos combines both the scientific and financial strength of two leading companies in their space,” said Dr. Simon Moroney, Chief Executive Officer of MorphoSys. “We are excited to combine our broad antibody expertise with Galapagos’ target discovery capabilities and disease know-how to form a successful partnership. The access to novel disease-related target molecules from a renowned partner accelerates the expansion of our proprietary antibody pipeline. This alliance also complements our development efforts in the field of inflammation and arthritis includingour lead program MOR103.”

With this strategic alliance, MorphoSys gains access to a proven target discovery engine as well as to Galapagos’ expertise in bone and joint disease, to support its therapeutic antibody pipeline expansion. The threemain indications of bone and joint disease – rheumatoid arthritis,osteoporosis and osteoarthritis – all represent very significant marketopportunities with several million people affected worldwide and combinedsales of drug treatments of more than US$ 15 billion in 2006.

Through the alliance with MorphoSys, Galapagos enters the rapidly growingmarket for therapeutic antibodies. In 2007, total sales for the 20antibody drugs on the market amounted to more than US$ 25 billion andantibody sales are forecast to increase to approximately US$ 50 billion in 2013. Fully human antibodies are recognized as the next generation and the majority of therapeutic antibodies currently in development are humanized or fully human. The average industry timescale from discovery to pre-clinical development of antibody therapies is only two to three years, considerably shorter than the average six years for small molecules.Antibodies also incur lower attrition rates than small molecules.

Galapagos and MorphoSys will conduct a conference call and live audio webcast today at 02:00 p.m. CET (8:00 a.m EST) to provide detailed information on the alliance.Dial-in number for the Conference Call (listen-only):Germany & U.K. residents: +32 2 401 53 06For U.S. residents: +1 866 931 1567 Please dial in 10 minutes before the beginning of the conference.Approximately two hours after the press conference, the archived webcast will be available for replay of the conference on http://www.morphosys.comand http://www.glpg.com.

For further information please contact: Dr. Claudia Gutjahr-Löser, Head ofCorporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-122, gutjahr-loeser@morphosys.com or Mario Brkulj, Manager CorporateCommunications & Investor Relations, Tel: +49 (0) 89 / 899 27-454,brkulj@morphosys.com

About Galapagos:

Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA; OTC: GLPYY)is a drug discovery company with pre-clinical programs in bone and jointdiseases and bone metastasis. Its BioFocus DPI division offers a fullsuite of target-to-drug discovery products and services to pharmaceuticaland biotech companies, encompassing target discovery and validation,screening and drug discovery through to delivery of pre-clinicalcandidates. BioFocus DPI also provides adenoviral reagents for rapididentification and validation of novel drug targets, compound libraries fordrug screening as well as chemogenomics and ADMET database products toselect targets and compounds. Galapagos currently employs about 450 peopleand operates facilities in six countries, with global headquarters inMechelen, Belgium. More information about Galapagos and BioFocus DPI canbe found at www.glpg.com and www.biofocusdpi.com.

About Galapagos’ target discovery technology:

Galapagos’ target discovery engine is based on adenoviruses thatefficiently introduce human gene sequences into a wide variety of humancells to knock-down specific proteins. High-throughput assays thatrepresent a selected human disease state are then used to functionallyselect for those proteins that have a causative effect in those models ofhuman disease. After rigorous validation of these protein targets, theyform the basis for the development of novel drugs.

About MorphoSys:

MorphoSys is a publicly traded biotechnology company focused on thegeneration of fully human antibodies as a means to discover and developinnovative antibody-based drugs against life-threatening diseases.MorphoSys’s goal is to establish HuCAL as the technology of choice forantibody generation in research, diagnostics and therapeutic applications.The Company currently has therapeutic and research alliances with themajority of the world’s largest pharmaceutical companies includingBoehringer Ingelheim, Centocor/Johnson & Johnson, Novartis, Pfizer andRoche. Within these partnerships, more than 50 therapeutic antibodyprograms are ongoing in which MorphoSys participates through exclusivelicense and milestones payments as well as royalties on any end products.Additionally, MorphoSys is active in the antibody research market throughits AbD Serotec business unit. The business unit has operations in Germany(Munich), the U.S. (Raleigh, NC) and U.K. (Oxford). For further informationplease visit http://www.morphosys.com/

HuCAL® and HuCAL GOLD® are registered trademarks of MorphoSys AG

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