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Biotech / Medical : Depotech(depo)

DEPO 7.300

+1.7%

Aug 14 5:00 PM EST

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To: John McCarthy who wrote (560)	12/18/1997 8:51:00 PM
From: Andrew H	Read Replies (2) of 887

John--I took the following passage from an older post by Tom D. Theseresults are similar to those in the article you quoted and do NOTappear to be the same results that the FDA saw. There is a strange discrepancy here, which may results in a lawsuit: >>The phase III study was a multicenter, controlled, nonblinded trial of 61 patients with neoplastic meningitis arising from solid tumors. They were randomized to treatment with either intrathecal DepoCyt every two weeks, or twice-weekly intrathecal methotrexate. 54 of the 61 patients were evaluable (more on this later). 36% of the 25 DepoCyt patients and 17% of the 29 methotrexate patients achieved the primary endpoint, a complete response. A complete response is two consecutive cerebrospinal fluid examinations which are free of cancer cells and no progression of abnormalities on neurologic exam. A secondary endpoint was median survival rate. This was 168 days in the DepoCyt group and 87 days in the methotrexate group. Another secondary endpoint was the mean time to disease progression which was 108 days with Depocyt and 48 days with methotrexate. <<

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