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Biotech / Medical : Biotech failure, 2002 -- Ignore unavailable to you. Want to Upgrade?

To: mopgcw who wrote (105)	9/16/2002 7:13:51 PM
From: Miljenko Zuanic	Read Replies (2) \| Respond to of 130

This is BAD for MLNM. Not as much as failure as it is BS report! Press Release Source: Millennium Pharmaceuticals, Inc. Millennium Announces Phase II Data for MLN02 in Crohn's Disease Monday September 16, 8:04 am ET CAMBRIDGE, Mass., Sept. 16 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced the results of a randomized, placebo-controlled phase II trial of MLN02 (formerly known as LDP-02) in patients with Crohn's disease. The study found that the primary endpoint of the trial, a decrease of greater than 70 points on the Crohn's Disease Activity Index (CDAI), was not achieved in either of the two MLN02 treatment groups. However, the clinically important secondary endpoint of the trial, disease remission, was achieved in the 2.0 mg/kg dose group. Overall, MLN02 appeared to be well tolerated in the study. (Photo: newscom.com ) In the 180 day study, a total of 185 patients with mild-to-moderate active Crohn's disease were randomized to receive either a 0.5 mg/kg, dose of MLN02, 2.0 mg/kg dose of MLN02 or placebo at days one and 29. At 57 days, neither treatment group showed a statistically significant difference from placebo in achieving response rates as defined by a decrease of greater than 70 points on the CDAI, a validated scale used to evaluate the severity of symptoms associated with Crohn's disease. There was a statistically significant difference seen between the 2.0 mg/kg (36.9%) and placebo (20.7%) groups in achieving remission (p<.05), and there was a trend towards dose response. Remission was defined as a score of <150 on the CDAI and correlates with the resolution of symptoms present during an active flare of the disease. No patients discontinued treatment in the trial due to drug-related adverse events. The adverse events that were more frequent in the MLN02 treatment groups over placebo were nausea and nasopharyngitis. There were no reported infusion or antibody-related reactions in this study.