As promised, I'm back this week with another clinical trials list covering experimental drugs currently undergoing testing in phase II and phase III studies by drug and biotech companies. This list serves as a companion to my June 10 column. Unlike U.S. Food and Drug Administration drug approvals, which are more precisely timed, the release dates for data from clinical trials is bit fuzzier, so the timelines here are culled from company guidance when possible. The working list of clinical trials expected to complete in 2009 is fairly long, so expect more information on clinical trials to watch in the coming weeks. I put this calendar together 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: GTx ( GTXI)
Drug/indication: Acapodene for precancerous prostate lesions (high-grade PIN)
Clinical trial event: phase III top-line results
Timing: late summer The phase III study will determine if treatment with Acapodene can reduce the occurrence of prostate cancer in men with high-grade PIN -- precancerous prostate lesions that place men at higher risk for prostate cancer. Company: Incyte ( INCY)
Drug/indication: INCB18424 for psoriasis
Clinical trial event: phase II results
Timing: late summer Incyte recently announced agreement with the FDA on endpoints for a phase III study of oral '8424 in patients with myelofibrosis. But the company is also developing a topical form of the drug for the treatment of mild to moderate psoriasis. Company: Jazz Pharmaceuticals ( JAZZ)
Drug/indication: JZP-6 for fibromyalgia
Clinical trial event: phase III top-line results
Timing: mid-2009
