regulatory milestones, plus additional undisclosed commercial milestone
-- Enrollment in CONNECTION, our confirmatory Phase 3 trial in
mild-to-moderate Alzheimer's disease, continues on track. All 30 of
our U.S. sites have been opened, and we expect the majority of our
ex-U.S. sites to be opened by the end of November. We expect to
complete enrollment of this trial in 2009.
-- Completed a randomized, double-blind safety and tolerability study of
combination therapy with Dimebon and donepezil (Aricept(R)) in patients
with Alzheimer's disease, which found the combination to be well
tolerated with no serious adverse events.
-- Plan to initiate new Phase 3 studies in 2009 to seek further
differentiation of Dimebon to include moderate-to-severe Alzheimer's
disease, adjunctive use with cholinesterase inhibitors, and
-- Received a Corporate Achievement Award from the Huntington's Disease
Society of America (HDSA) for exemplifying leadership in the fight
against Huntington's disease and other neurodegenerative diseases.
-- Plan to initiate the next Huntington's disease efficacy study in 2009.
MDV3100: Drug candidate to treat castration-resistant prostate cancer
-- Presented data at the 20th EORTC-NCI-AACR Symposium on "Molecular
Targets and Cancer Therapeutics" from an ongoing open-label,
dose-escalation, U.S.-based Phase 1-2 clinical trial in prostate cancer
patients who have failed standard hormonal therapies. Results showed
encouraging and durable anti-tumor activity in the three expanded dose
groups tested thus far, as measured by prostate specific antigen (PSA)
declines, radiographic findings, circulating tumor cell (CTC) changes,
and time on treatment. MDV
|SOURCE Medivation, Inc.|
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