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Medivation Announces First Patient Dosed in Phase II Trial With Dimebon for Treating Alzheimer's Disease

Posted on: Friday, 9 September 2005, 06:00 CDT

Medivation, Inc. (OTCBB: MDVN) today announced that patient dosing in its Phase II Alzheimer's disease study with Dimebon began on September 8, 2005. This randomized, double-blinded, placebo-controlled study is being conducted at approximately 12 sites in Russia, and will enroll up to 166 patients. The study's clinical endpoints are the same ones used by the U.S. Food and Drug Administration to approve all of the presently marketed Alzheimer's disease drugs. Medivation estimates that patient dosing in this study will be completed by June 30, 2006.

David Hung, MD, President and Chief Executive Officer of Medivation, stated: "We are delighted to announce that we have reached this important corporate milestone. As we have previously stated, our goal was to begin patient dosing in our Phase II Alzheimer's disease study by September 30, 2005, and are pleased that we have done so on schedule."

Dimebon has been approved for use in Russia as an anti-histamine since 1983. More recently, Dimebon was shown to bind to both of the two presently validated targets for the treatment of Alzheimer's disease - cholinesterase and the NMDA receptor. In addition, Dimebon also blocks a third target which, while not yet validated for the treatment of Alzheimer's disease, has been linked to Alzheimer's disease in published literature. Dimebon has been shown to improve learning and memory in animal models of Alzheimer's disease and in an open-label 14-patient pilot clinical study in Alzheimer's disease patients. The novel findings in these studies enabled Medivation to obtain issued patents in the U.S. and Europe covering the use of Dimebon to treat Alzheimer's disease and other neurological diseases.

Lynn Seely, MD, Chief Medical Officer of Medivation, noted: "I am impressed with the caliber of the investigators participating in this study, and with their enthusiasm for this project. I have met with most of our principal investigators, and my colleagues and I will continue to work closely with them as we continue to enroll patients into this study."

Simultaneously with the Russian Phase II study, Medivation is conducting animal studies in the U.S. required to obtain FDA approval to begin U.S. clinical trials. The Company expects to file an IND with the FDA for Dimebon by June 30, 2006. Dimebon tablets already have been manufactured in compliance with U.S. good manufacturing practices (GMP) for use in the planned U.S. clinical studies.

Dr. Hung continued: "The initiation of our Russian Phase II study on schedule, as well as our continued progress in the U.S. toward our planned IND filing, keeps us on track to implement our strategic plan for Dimebon. Should the results of our studies be positive, by next summer we would have human proof-of-concept data in a large, high-quality clinical trial, FDA approval to initiate human clinical studies in the U.S., and GMP Dimebon tablets for use in those U.S. trials. We believe we would be in a strong position at that time to partner our Alzheimer's disease program with a pharmaceutical company or to sell it outright."

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 IP and safety data and hints of efficacy, that address large markets, 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 ROIs of at least 6-times 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. 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. The Company's second product candidate is the MDVN300 family of small molecules, which are in preclinical development for treatment of prostate cancer that has become resistant to standard hormonal therapies. For further information regarding Medivation and our development programs, please refer to our Annual Report on Form 10-KSB for the year ended December 31, 2004 and our Quarterly Report on Form 10-QSB for the quarters ended March 31, 2005 and June 30, 2005, as filed with the Securities and Exchange Commission.

Forward-Looking Statements

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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