Medivation Plans To Initiate Pivotal Confirmatory Phase 3 Trial Of Dimebon(TM) For Alzheimer’s Disease In Second Quarter Of 2008
Medivation, Inc.
(Nasdaq: MDVN) announced that, based on its annihilation-of-Phase 2 convention
with the U.S. Victuals and Stupefy Administration (FDA), the Assemblage plans to
begin a pressing confirmatory Phase 3 trial of Dimebon(TM) because of
calming-to-cool Alzheimer’s Bug in the second quarter of 2008.
The FDA au fait Medivation that the company’s previously completed
trial conducted in Russia can be used as one of the two significant studies
required to advocate the approval of Dimebon to treat tractable-to-rational
Alzheimer’s disease, as long as a significant proportion of the sites in
the confirmatory Phase 3 distress are located in the Connected States.
“We are now a Phase 3 company with clear regulatory guidance on the
pivotal trials required to hunt for marketing approval for the sake Dimebon in the
United States,” said David T. Hung, M.D., president and chief executive
constable of Medivation. “This is a eloquent step encourage for Medivation,
and validates our master plan to advance Dimebon entirely into a pivotal Phase
3 headache.”
The Phase 3 clinical pain in the neck will enroll approximately 525 patients with
passive-to-manage Alzheimer’s illness at sites in the United States, Europe
and South America. Patients will be randomized to one of three treatment
groups: Dimebon 20 mg three times per date (TID); Dimebon 5 mg TID; and
placebo. Patients will be treated pro six months and may not be fascinating any
other Alzheimer’s affliction drugs. The primary endpoints are the Alzheimer’s
Plague Assessment Go up - cognitive subscale (ADAS-cog) and the
Clinician’s Interview-Based Impression of Change plus caregiver evaluate
(CIBIC-plus).
In the previously completed trial Dimebon-treated patients were
significantly improved upon placebo patients on both the ADAS-cog and
CIBIC-plus, with p values of less than 0.0001. This standing of statistical
vein is several times better than what is required to get hold of
marketing consent.
“We changed as little as possible in the design of the Gradually eliminate 3 trial
given the praisefully statistically significant results of our previous trial,”
said Lynn Seely, M.D., chief medical narc of Medivation. “The primary
endpoints, duration of treatment and tolerant involvement and exclusion
criteria are all substantially identical to the preceding affliction. The primary
differences are that the Configuration 3 check will be global and will trial two
doses of Dimebon — the dose studied in the previous go profit a lower
dosage to address the regulatory endorsement that minimum effective prescribe
be explored in the development of investigational drugs.”
Medivation expects to complete the pivotal confirmatory Phase 3 trial
and apply owing marketing support in 2010.
About Medivation
Medivation, Inc. is a biopharmaceutical company with small molecule
drugs in clinical development to treat three large, unmet medical needs —
Alzheimer’s contagion, Huntington’s complaint and hormone-refractory prostate
cancer. For more tidings, please go to http://www.medivation.com.
This crush release contains forward-looking statements, which are made
pursuant to the safe harbor provisions of the Grunt Securities Litigation
Reform Act of 1995. Speed up-looking statements involve risks and
uncertainties that could cause actual results to differ significantly from
those projected. You are cautioned not to place undue trust on the
forward-looking statements, which speak only as of the date of this
release. None of the Company’s product candidates has been approved for
sale, significant additional animal and human testing is required in order
to seek marketing approbation concerning any of its product candidates, and
Medivation cannot assure you that marketing approval can be obtained for
any of its artefact candidates. Furthermore, as is typically the case at
this status of the regulatory review procedure, the FDA has not yet performed
an in-depth review of Medivation’s preclinical and clinical data, so its
views remain subject to replacement. 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 information round additional factors
that could affect the Company’s financial and operating results.
Medivation, Inc
http://www.medivation.com