Biotech Calendar: More Key Clinical Trial Dates

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

This is the second of two phase III studies of JZP-6 in patients with fibromyalgia. Results from the first study were announced in last November and then presented at a medical meeting last week. JZP-6 contains the same active ingredient as in Xyrem, a drug marketed by Jazz for the treatment of excessive daytime sleepiness.

Company: Orexigen Therapeutics ( OREX)
Drug/indication: Contrave for obesity
Clinical trial event: Phase III top-line results
Timing: third quarter

Three phase III studies treating obese patients with Contrave or placebo for one year will report results in the third quarter. Orexigen reported data from a previous phase III study in January.

Company: Vivus ( VVUS)
Drug/indication: Qnexa for obesity
Clinical trial event: phase III top-line results
Timing: third quarter

Two phase III studies treating obese patients with Qnexa or placebo for one year will report results in the third quarter.

Company: Alkermes ( ALKS)
Drug/indication: Vivitrol for opioid dependence
Clinical trial event: phase III top-line results
Timing: fourth quarter

Alkermes is seeking to expand the commercial market for Vivitrol beyond its current use as a treatment for alcohol dependence.

Company: Celgene ( CELG)
Drug/indication: Apremilast for psoriatic arthritis
Clinical trial event: phase II results
Timing: mid 2009

Apremilast is a drug designed to treat psoriasis and other inflammatory diseases.

Company: Poniard Pharmaceuticals ( PARD)
Drug/indication: Picoplatin for small cell lung cancer
Clinical trial event: phase III results
Timing: third quarter

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.

Company: Medarex ( MEDX) and Bristol-Myers Squibb ( BMY)
Drug/indication: ipilimumab for metastatic melanoma
Clinical trial event: phase III top-line results
Timing: end of 2009

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.

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; click here to send him an email.

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