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Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?

To: John McCarthy who wrote (838)	10/12/1998 8:39:00 PM
From: John McCarthy	Read Replies (1) \| Respond to of 887

Note to myself: What the FDA said back then ... <<DepoCyt™ (cytarabine lipid-particle injection, DepoTech Corporation): On the afternoon of December 18, 1997, a new drug application for DepoCyt was considered for the indication of “intrathecal treatment of neoplastic meningitis of patients with solid tumors, lymphoma, or leukemia.” The application was based on data from 3 small trials in patients with carcinomatous meningitis from solid tumors only; 61 patients in a Phase III randomized study, 4 patients in a pharmacokinetic study and 9 patients in a Phase I study. A response was defined as a cytologic response without clinical progression. When the results of all patients with solid tumors receiving DepoCyt were pooled, responses were observed in 14/44 (32%). In the randomized trial comparing intrathecal therapy with DepoCyt to intrathecal therapy with methotrexate, the response rate was 26% (8/31) for DepoCyt and 20% (6/30) for methotrexate (p = 0.76). The median duration of clinical response was 39 days for DepoCyt vs. 26 days for methotrexate (p = 0.95). The median time to clinical progression was 167 days for DepoCyt vs. 67 days for methotrexate (p = 0.03), the median time to cytologic progression was 51 vs. 84 days (p = 0.49), and the median survival was 421 vs. 133 days (p = 0.19). Chemical arachnoiditis with DepoCyt occurred in 64% (38/59) of patients and 28% (59/208) of cycles and was serious and definitely or possibly related in 29% (11/38) of patients and 6% (13/208) of cycles. Because of the small number of patients, the committee voted that the studies could not be considered adequate and well controlled. The committee was evenly split on the question of whether cytologic responses in patients with carcinomatous meningitis from solid tumors in the absence of clinical progression was a surrogate endpoint that predicted clinical benefit. Although the time to clinical progression was significantly longer for DepoCyt in the randomized trial and there was evidence of cytologic responses in the 3 small trials, the committee did not feel that there was substantial evidence of clinical efficacy in solid tumor patients.>> ascobeta.infostreet.com