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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM)

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To: Icebrg who wrote (2271)11/16/2004 12:55:13 PM
From: Icebrg  Read Replies (3) of 3044
 
Velcade in solid tumors - part II

Boronate @ Yahoo! reports from the R&D day (which webcast I have not been able to access).

R&D
by: boronate 11/16/04 11:26 am
Msg: 56077 of 56081

Just heard the R&D day presentation on BAC, a subtype of NSCL (~20%). There are some "dramatic responses" in this subtype and Mlnm will initiate a Phase II of this trial in the 1H of 2005.

Decision point on current PII Velcade or Velcade plus Taxotere by the end of this year.

The SWOG frontline trial with cisplatin and gemcitabine, initiated soon after ASCO, has nearly completed its enrollment. I will expect data as early as ASCO next year.

Re: R&D
by: boronate 11/16/04 12:45 pm
Msg: 56081 of 56081

The importance of BAC cannot be overstated. It may represent the majority of the responses seen in the current lung trials and may explain why the response rate vary so much among the small investigator-initiated trials. It is certainly a subtype that can lead to FDA approval. The new trial is a single agent trial so the response will be unmistakeble. Judging from the case presented today and a similar one shown in ASCO 2003, major responses and remission can be obtained with Velcade as a single agent. The trial can accure patients rapidly and certainly can be completed within a year from initiation. So we are looking at 2006 for an NDA. While solid tumor trials are never easy, when one sees single agent activity that falls into the major response category and a drug is apready safe in human, the bet is quite, or even extremely, good. cheers.
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