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Biotech / Medical : Alexion Pharmaceuticals, Inc. (ALXN)
ALXN 182.500.0%Jul 28 5:00 PM EST

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To: keokalani'nui who wrote (243)11/7/2002 7:53:21 PM
From: Miljenko Zuanic  Read Replies (1) of 824
 
OT, (this should be discussed at MLNM tread):

WE,

<<My notes say trial originally planned for 74 but was expanded to 202 so there should be more than 54 coming.>.

I think this was for second PII trial.

Originally (first press release for PII) it was planned ~200 pts. Also, as I remember, they announce enrollment completion before deadline for AHS abstract submission, but maybe they didn't have end of treatment data. In addition, they started PIII trial (second line therapy against DEX) before full data on "first relapse PII" were known. So, maybe they have early signal that there is no significant additional benefit with DEX, or that best way to penetrate market is to show superiority over DEX (which I think is reasonable approach).

<<...something like "70% population achieves reduction in tumor burden of 30% with V." From 7/16 oncology day CC.>>

Is this after adding DEX, or based on V monotherapy? I think that they are holding results for ASH presentation.

Words in abstract indicate (gut filing) that there is additional benefit by adding DEX for (at least) pts with stable paraprotein level.

They have to differentiate V from CELG thalidomid analogue, if they want to be major player for MM.

Miljenko
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