IDPH--Positive preliminary results for pivotal trial of ID Message Board

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

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To: I. Luttichuys who wrote (253)	12/19/1996 7:50:00 PM
From: Brad C. Dunlap	of 1762

Hi Bennett, today there was an interesting press release from Coulter Pharm. The article confirmed that the first patients were treated in its pivotal phase II/III trial for nhl . They also updated thier previous study of which 40 patients with low- grade or transformed low-grade nhl patients were treated with their iodine-131 monoclonal antibody. Of these 82% showed an overall response and 45% showed a complete response. They did not comment on toxicities. Results of the previous mentioned study were reported in the July issue of the Journal of Clinical Oncology and there appears to be some changes in their efficacy with the addition of more patients. These earlier results showed 28 patients given a radioimmunotherapeutic dose 79% achieved a complete or partial response and 50% achieved a complete response. Of 34 patients that they intended to treat 6 developed hama response. All or 100% of the13 low grade patients achieved a partial or complete response and 10 achieved complete response. As stated before this is very impressive and old news. However, today's release stated that 40 patients with low grade or transformed low-grade nhl, 82% showed an overall response and 45% showed a complete response. This also is very impressive but clearly the % have come down on the low grade nhl from their earlier report. A number of reasons could account for the change in numbers such as receiving new data with the additional patients, or due to the fact that they will become a public company in the beginning of the new year,Hembrecht & Quist for liability reasons made them report in a more conservative manner. I don't know but their radiation monoclonal is now showing efficacy lower then C2B8/chemo. To be fair, Coulter's results are on patients who have relapsed at least one previous treatment and the C2B8/chemo results were initial treatment which should make treatment a bit easier. It is clear that they intend to move their product quickly through the FDA based on the new Clinton-Kessler cancer initiative. Does this mean an early filing? I quess will have to wait until the new offering prospectuses are available. I didn't get a chance to speak to Idec in this matter but I'm sure whatever Coulter ends up doing down the road the same will be for YB28 since C2B8 will already be on the mkt.

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