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February 26, 2007
Medivation's MDV3100 Shown to Be Effective in a Preclinical Model of Hormone-Refractory
Prostate Cancer
- Data Presented in Oral and Poster Presentations at ASCO's Prostate Cancer Symposium SAN FRANCISCO, Feb 26, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Medivation, Inc. (AMEX: MDV) today
announced that results from a preclinical study suggest that MDV3100, the Company's lead development candidate for
hormone-refractory prostate cancer, is effective in a model of the disease. The data were presented by Charles L. Sawyers,
M.D., in an oral presentation (abstract #48) at the American Society of Clinical Oncology's (ASCO) Prostate Cancer Symposium
in Orlando, Fla. during a session entitled "Imaging and Novel Therapeutics."
"All men who die of metastatic prostate cancer die from hormone-refractory disease," said Dr. Sawyers, chairman of the Human
Oncology and Pathogenesis Program at Memorial Sloan-Kettering Cancer Center in New York. "While prostate cancer growth
is driven by androgens like testosterone, current anti- androgen therapies do not stop the growth of hormone-refractory
prostate tumors. These preclinical findings with MDV3100 are extremely promising because MDV3100 not only dramatically
inhibited the growth of otherwise refractory human prostate tumors, but in half of the cases the tumors regressed. I am unaware
of any other therapies that show similar effects in hormone-refractory prostate cancer."
Results of the research showed that MDV3100 treatment was associated with a significant dose-dependent reduction in tumor
volume (p<0.05) in human hormone-refractory prostate tumors grown in SCID mice. When left untreated, these human tumors
approximately doubled in volume over a 28-day period. By contrast, treatment with MDV3100 over the same period caused
these tumors to shrink. Most notably, in the high-dose group, tumor volume was reduced to non-measurable levels in three of
seven animals.
"We are very encouraged by these preclinical results and are planning to initiate a U.S. Phase 1-2a trial in patients with
hormone-refractory prostate cancer in the first half of this year," said David Hung, M.D., president and chief executive officer of
Medivation. "If that trial shows MDV3100 to be tolerated and to inhibit serum prostate-specific antigen levels, we expect to
proceed directly to Phase 3 clinical trials in hormone-refractory prostate cancer."
About MDV3100
MDV3100 is the lead development candidate from a library of approximately 170 small molecules licensed by Medivation.
These molecules were rationally designed to treat hormone-refractory prostate cancer by inhibiting the androgen receptor (AR)
in a different manner from currently approved AR antagonist drugs, which are ineffective in treating prostate cancers that have
become hormone-refractory.
About Prostate Cancer
Prostate cancer is the most common type of cancer in men in the United States, apart from skin cancer, and kills more than
27,000 men each year in the U.S., making it the second leading cause of cancer death in men. Prostate tumors that have
stopped responding to or are growing despite the use of active hormone treatment strategies are characterized as hormonerefractory.
About Medivation
Medivation, Inc. is a biopharmaceutical company that acquires promising technologies in the late preclinical development phase
and develops them quickly and cost-effectively. Medivation's current portfolio consists of small molecule drugs in development
to treat three large, unmet medical needs -- Alzheimer's disease, Huntington's disease and hormone-refractory prostate
cancer. The Company intends to build and maintain a portfolio of four to six development programs at all times. For more
information, please go to www.medivation.com.
This press release contains forward-looking statements, including statements regarding anticipated clinical development
strategies and clinical trial dates, 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 that the Company has not yet received approval from the U.S. Food and
Drug Administration, or any foreign regulatory body, to begin clinical studies of MDV3100, and that Medivation cannot assure
you that it will be able to obtain such approval on reasonable conditions or at all. Medivation's filings with the Securities and
Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2006, include more
information about factors that could affect the Company's financial and operating results.
SOURCE Medivation, Inc.
Patrick Machado, Chief Financial Officer of Medivation, Inc., +1-415-543-3470,
ext.201; or Jani Bergan of WeissComm Partners, +1-415-946-1064
http://www.medivation.com/
Copyright (C) 2007 PR Newswire. All rights reserved
News Provided by COMTEX