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发帖数: 714 | 1 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.
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)
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. |
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