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Strategies & Market Trends : Biotechnology Cancer Cures

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To: Phil Cressman who wrote (92)	8/15/1999 7:24:00 PM
From: chirodoc	of 226

phil, i took this from yhoo P3 Trial Size & Timeframe by: Interludes_Palace (40/M/Florida) 7154 of 7171 I forgot who asked about the P3 trial size...but I did find something interesting. I know that the same company that oversaw the Herceptin trial is working with Biomira on their trial. The Herceptin trial was 900 patients...heh...probably not a coincidence. To give everyone an idea of timeframes... Herceptin first data set was released on 12/97 Herceptin fast tracked 3/31/98 Herceptin approved for marketing 8/98 This is interesting considering the Herceptin results: - Herceptin only works at all on 30% of women with breast cancer - Herceptin w/ chemo improved tumor shrinkage 15% - Herceptin alone had a 16% response - Herceptin had adverse side-effects about 27% of the time - Total life expectancy was raised about 3 months Everyone has to remember that the criteria for approval of a cancer treatment is a lot different than most other diseases because of the level of fatality. All of the data I've seen for Theratope is quite a bit better than Herceptin. With the new formulation, the bridging study showed 96% of patients responded after only two weeks, with 30% of those achieving a higher rate of response than maximum seen in the [phase 2] formulation. Also remember that the seperate stem cell study witht the OLD formula showed a doubling of life expectancy. We are well above efficacy levels required for approval, imho. IP

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