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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (2318)	2/20/2005 12:45:37 PM
From: Ian@SI	Read Replies (1) \| Respond to of 3044

Part 3: VELCADE(R) (bortezomib) for Injection in combination with docetaxel in patients with advanced androgen independent prostate cancer A phase I/II study of VELCADE in combination with docetaxel, being led by Robert Dreicer, M.D., at the Cleveland Clinic Foundation, Cleveland, OH, examined the dose-limiting toxicities, maximum tolerated dose, and the effects on PSA levels of VELCADE and docetaxel, both given weekly for two out of three weeks, in patients with advanced androgen-independent prostate cancer. Two dose levels were expanded into phase II cohorts, one with VELCADE 1.3mg/m2 and docetaxel 40 mg/m2, the second with VELCADE 1.6mg/m2 and docetaxel 40 mg/m2. Anti-tumor responses in patients with measurable disease were evaluated based on the RECIST criteria and confirmed four to six weeks after the first documentation of a complete or partial response. In addition, anti-tumor activity was evaluated based on a sustained PSA decline of more than 50 percent confirmed by two separate measurements at least four weeks apart. Investigators reported the following results: * In the cohort in which patients were treated with VELCADE 1.3mg/m2 and docetaxel 40 mg/m2: -- Of 25 evaluable patients, six patients (24 percent) achieved a confirmed PSA decline of more than 50 percent of which four patients achieved a confirmed PSA decline of at least 90 percent; and -- 100 percent of the 13 patients with measurable disease achieved either partial remission or stable disease, specifically three achieved partial remission. * In the cohort in which patients were treated with VELCADE 1.6mg/m2 and docetaxel 40 mg/m2: -- Of 28 evaluable patients, 10 (36 percent) had a PSA decline of more than 50 percent; -- 78 percent of 18 patients with measurable disease achieved partial remission or stable disease, specifically two patients achieved partial remission. * Adverse events observed included fatigue, gastrointestinal events, neuropathy, and hematologic toxicities.