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Biotech Calendar: Key Upcoming Trials

Your quick-and-dirty guide to upcoming phase III clinical trials.



) --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.



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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.


Bristol-Myers Squibb

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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.


Chelsea Therapeutics


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.




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.


Gilead Sciences

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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

reported last May



Human Genome Sciences


Drug/indication: Benlysta for lupus

Timing: Nov. 2, 2009

Benlysta tries to make it two-for-two in phase III lupus studies.



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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.


Optimer Pharmaceuticals


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.


Poniard Pharmaceuticals


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 In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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