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Medivation Acquires Novel Compounds to Treat Hormone-Refractory Prostate Cancer

Posted on: Monday, 19 September 2005, 06:00 CDT

Medivation, Inc. (OTCBB: MDVN) today announced the acquisition of a series of novel small molecule compounds (the MDVN 300 series of compounds) targeting hormone-refractory prostate cancer (HRPC). These compounds are based on a key discovery in the field of prostate cancer by Charles Sawyers, M.D., Peter Bing Professor and a Howard Hughes Medical Investigator at the University of California, Los Angeles, and recipient of the 2005 Karnofsky Memorial Award from the American Society of Clinical Oncology. Medivation intends to begin clinical development with these compounds by the end of 2006.

"The MDVN 300 compounds hold potential to help HRPC patients who currently face largely ineffective treatment options. These compounds were identified through Dr. Sawyers' pioneering work to learn the reasons prostate cancer patients become resistant to hormone therapy, and we are quite enthusiastic about the preclinical data Dr. Sawyers has generated with them," said David Hung, M.D., President and Chief Executive Officer of Medivation.

"Medivation seeks to build a portfolio of technologies that address large, unmet clinical needs, have strong intellectual property positions and can enter clinical development within 12 to 18 months after acquisition," he added. "This promising new HRPC treatment technology meets all strategic objectives of our business model."

The current standard of care for treating metastatic prostate cancer includes drugs that block the ability of testosterone to fuel the growth of prostate cancer cells. However, after an average of 2-3 years of treatment, virtually all metastatic prostate cancer becomes resistant to hormone therapy. This stage is known as hormone-refractory prostate cancer, which has very limited treatment options. Chemotherapy is often used but extends survival modestly, typically by only a few months.

Dr. Sawyers discovered that one of the important mechanisms by which resistance develops is over-expression of the androgen receptor. This finding, which was published in the journal Nature Medicine in 2004, was important in guiding the design of potential new therapeutic agents to treat HRPC.

Based on this key discovery, Dr. Sawyers in collaboration with Michael Jung, Ph.D., in UCLA's Department of Chemistry and Biochemistry, rationally designed a series of more than 160 novel small molecule compounds to bind to and block the androgen receptor in a manner designed to treat HRPC. Their tests of the compounds in human HRPC cells found that several of the compounds appeared to inhibit the growth of those cells better than Casodex(R), a leading hormonal therapy that generated more than $1 billion in global sales in 2004.

Dr. David Hung concluded, "The prostate cancer indication is particularly interesting because we can use prostate-specific antigen (PSA), a widely used serum marker of prostate cancer growth, to follow tumor responses to get an early indication of efficacy. We believe this may facilitate the timely selection of an optimal dose of our lead molecule for a pivotal efficacy study, which could shorten timelines and lower the risk of this program."

About Medivation

Medivation, Inc. acquires and develops drug and medical device product candidates with a focus on early clinical development only (no discovery or Phase III trials). The Company seeks development candidates that have strong intellectual property positions that address large unmet medical needs and that have the potential to be in clinical development within 12-18 months of acquisition. Development activities are largely outsourced to contract research organizations to minimize infrastructure and overhead. The Company targets development candidates with the potential to generate returns on investment of at least 6-fold in 3 years by sale to or partnership with established drug or device companies.

The Company's first product candidate is Dimebon(TM) for Alzheimer's disease (AD). Dimebon is a small molecule that has a 20-year record of human use, targets the same mechanisms as other AD therapeutics approved by the U.S. Food and Drug Administration, has demonstrated improvement in cognition/memory in a pilot AD clinical trial and has demonstrated preclinical evidence of anti-aging properties. Dimebon currently is in a randomized, double-blind, placebo-controlled Phase II study in up to 166 Alzheimer's disease patients in Russia. The Company's second product candidate is the MDVN300 family of small molecules, which is scheduled to enter clinical development for treatment of hormone-refractory prostate cancer by the end of 2006.

Safe Harbor

This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties that could cause actual results to differ significantly from those projected. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-KSB for the year ended December 31, 2004 and our Quarterly Reports on Form 10-QSB for the quarters ended March 31, 2005 and June 30, 2005, include more information about factors that could affect our financial and operating results.

Source: Business Wire

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