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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: Maurice Winn who wrote (1429)1/16/1998 12:42:00 PM
From: Pseudo Biologist  Read Replies (2) of 1762
 
Maurice, here is the (only?) easy answer; the URL is ex2.excerptamedica.com It's not the most user friendly in the world. It helps to know some important author names such as Grillo-Lopez from IDEC and Kaminski from Michigan, funded by Coulter.

Now to the speculation - everyone is welcome to correct, support, make fun of, destroy, enhance, etc.

- I see CD20 presence as a necessary but not sufficient factor for Rituxan to be effective. If the cancer is growing too quickly (and this MAY depend on whether it is follicular/low-grade/high-grade or other such "medieval" characterization), the killing/cytostatic effects of Rituxan MAY not represent a sufficient "punch." I say this based on experience with OTHER anti-tumor marker "naked" Abs. Adding radioactivity as in Bexxar or in Y2B8 MAY help, but of course, you do worsen the side effect profile. By how much that would happen, I leave to the CLTR/IDPH/TCLN/etc bulls/bears to resolve.

- your opinion on point of intervention vs. clinical trials may be valid, but if you go back to Scott's posts on the strategy companies follow in order to assure FDA approval, you may see the issue differently. In other words, the clinical strategy that minimizes time to market may differ drastically from the ideal way in which a drug may ultimately find wide use. Also, for low-grade at least, the survival expectation after initial diagnosis is measured in years (5 or more?) because CHOP or related treatments are effective for a while. I can therefore understand the hesitance of FDA or other medical authorities, back when Rituxan was beginning to be tested, to encourage "front-line" use. The situation today may be different and, as discussed here recently, pretty much up to the attending physician.

PB
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