Biotech Calendar: Key Upcoming Trials
BOSTON (
) --I've put together an updated list of phase III clinical trials with results expected through the first quarter 2010. The companies included here are listed in alphabetical order.
Unlike U.S. Food and Drug Administration drug approvals, which are more precisely timed, the release dates for data from clinical trials is a bit fuzzier, so the timelines here are culled from company guidance when possible.
This list was compiled using company reports, sell-side research and the BioMedTracker service from Sagient Research, a subscription-based tool for keeping track of biotech and drug catalysts.
Company:
Alkermes
(ALKS) - Get Report
Drug/indication: Vivitrol for opioid dependence
Clinical trial event: Phase III top-line results
Timing: Fourth quarter 2009
Alkermes is seeking to expand the commercial market for Vivitrol beyond its current use as a treatment for alcohol dependence.
Company:
Bristol-Myers Squibb
(BMY) - Get Report
Drug/indication: ipilimumab for metastatic melanoma
Clinical trial event: Phase III top-line results
Timing: First quarter 2010
The phase III study enrolls patients with previously untreated metastatic melanoma and treats them with a combination of ipilimumab plus the chemotherapy dacarbazine or dacarbazine plus placebo.
Company:
Chelsea Therapeutics
(CHTP)
Drug/indication: Droxidopa for orthostatic hypotension
Timing: Fourth quarter 2009
Chelsea is hoping for better results from the second of two pivotal studies of droxidopa in patients with orthostatic hypotension, a condition in which blood pressure drops when a patient stands up, causing dizziness and other symptoms. The initial phase III study failed in September, although the drug did show some beneficial activity.
Company:
Genta
(GETA.OB)
Drug/indication: Genasense for metastatic melanoma
Timing: Fourth quarter 2009
Genta says it has finally found a subgroup of melanoma patients who will benefit from treatment with Genasense. The results of this study will tell the tale.
Company:
Gilead Sciences
(GILD) - Get Report
Drug/indication: Darusentan for resistant hypertension
Timing: Fourth quarter 2009
This is the second of two phase III studies of darusentan. Results from the first phase III study were
.
Company:
Human Genome Sciences
(HGSI)
Drug/indication: Benlysta for lupus
Timing: Nov. 2, 2009
Benlysta tries to make it two-for-two in phase III lupus studies.
Company:
ImmunoGen
(IMGN) - Get Report
and
Roche
Drug/indication: Trastuzumab-DM1 for metastatic breast cancer
Timing: Fourth quarter 2009
While technically a single-arm phase II study in third-line breast cancer patients, Roche plans to seek regulatory approval for T-DM1 if results are positive.
Company:
Optimer Pharmaceuticals
(OPTR)
Drug/indication: Fidaxomicin (OPT-80) for clostridium difficile infection
Clinical trial event: Phase III results
Timing: Fourth quarter 2009
In the first phase III study last year, fidaxomicin outperformed vancomycin, the current standard of care for patients infected with the clostridium difficile bacteria. Optimer is hoping that the second phase III study yields the same positive results, which will allow the company to seek the drug's marketing approval.
Company:
Poniard Pharmaceuticals
(PARD)
Drug/indication: Picoplatin for small cell lung cancer
Clinical trial event: Phase III results
Timing: Fourth quarter 2009 (November likely)
Poniard is developing picoplatin in a variety of cancer indications, but the data from the phase III study in small cell lung cancer, if positive, will form the basis of the company's initial approval filing with the FDA.
-- Reported by Adam Feuerstein in Boston
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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