Medivation (AMEX:MDV)
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Medivation, Inc. (AMEX:MDV) today announced that on May
8, 2006 it received a letter from the U.S. Food and Drug
Administration (FDA) regarding its investigational new drug (IND)
application to begin human testing of Dimebon for Huntington's
disease. The letter confirmed the information initially communicated
by the FDA in a February 28, 2006 telephone call that additional rat
toxicology data are required before human clinical trials can begin.
The FDA expressed the concern that the dose levels of Dimebon used in
one of Medivation's rat toxicology studies did not result in
sufficient toxicity to define a maximum tolerated dose. This
information might provide additional guidance to physicians regarding
the potential toxicities of Dimebon in humans.
To address the FDA's concern, in March 2006 Medivation initiated
additional rat toxicology studies to evaluate Dimebon at higher doses
than those used in the prior study. Medivation expects to have
sufficient data in the third quarter of 2006 to request the FDA to
allow initiation of the proposed Phase 1-2a clinical study of Dimebon
in patients with Huntington's disease.
About Medivation
Medivation, Inc. acquires promising pharmaceutical and medical
device technologies in the late preclinical development phase, and
develops those technologies quickly and cost-effectively through human
first proof-of-efficacy studies (generally the end of Phase 2 clinical
trials). Depending on the indication, Medivation will either seek to
sell or partner successful programs with larger pharmaceutical,
biotechnology and medical device companies for late-stage clinical
studies and commercialization, or alternatively conduct those
activities internally. The Company intends to build and maintain a
portfolio of 4 to 6 development programs at all times.
Medivation's current portfolio consists of small molecule drugs in
development to treat 3 large, unmet medical needs -- Alzheimer's
disease, Huntington's disease and hormone-refractory prostate cancer,
the last two of which are likely Orphan Drug indications. Dimebon(TM),
with a 20-year record of human use and demonstrated efficacy in animal
studies of both Alzheimer's disease (AD) and Huntington's disease (HD)
and in a pilot clinical study of AD, is in a randomized, double-blind,
placebo-controlled Phase 2 study in AD patients in Russia, the results
of which are expected to be available in Q3 2006. Medivation also
expects to initiate a Phase 1-2a study of Dimebon in HD patients in
2006, and a Phase 1-2a study of the lead MDV300 series compound in
hormone-refractory prostate cancer patients in the first half of 2007.
Further information about Medivation can be found on its website
(www.medivation.com).
Safe Harbor Statement
This press release contains forward-looking statements, including
statements regarding the anticipated timing of regulatory and clinical
milestones on the Company's Alzheimer's disease, Huntington's disease
and hormone-refractory prostate cancer programs, 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, 2005, include more information about
factors that could affect our financial and operating results.