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Biotech / Medical : Corcept Therapeutics Incorporated (CORT)

CORT 74.20

+1.0%

3:59 PM EST

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To: Clarksterh who wrote (23)	9/26/2005 10:16:05 PM
From: tuck	Read Replies (1) of 32

Now delays in delay in enrollment, forcing the trial to be halved, and with with insufficient power for statistical significance. I would expect that many AD trials could suffer from this issue: >>MENLO PARK, Calif., Sept. 26 /PRNewswire-FirstCall/ -- Corcept Therapeutics Incorporated (Nasdaq: CORT - News) today announced that it plans to close enrollment in its clinical study evaluating the safety and efficacy of CORLUX® to improve cognition in patients with mild to moderate Alzheimer's disease. Ongoing review of blinded safety data has not revealed any serious safety findings. Patients in this trial were dosed with an acetylcholinesterase inhibitor, medications that are routinely prescribed for patients with Alzheimer's disease, and CORLUX or placebo. The study protocol prohibited the concomitant use of Namenda (memantine), a recently approved treatment for Alzheimer's disease which was commercialized after the Corcept trial was initiated. Because a majority of Alzheimer's disease patients are now treated with the combination of Namenda and an acetylcholinesterase inhibitor, enrollment in the Corcept study slowed significantly. The study has enrolled 80 patients to date. It was designed to enroll 160. "Although this study is not powered to show statistically significant results with only 80 patients, we will analyze the data and see what we can learn," said Joseph K. Belanoff, M.D., Chief Executive Officer of Corcept. "We expect to report the results of this trial in the First Quarter of 2006."<< snip Cheers, Tuck

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