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: Rick Costantino who wrote (53)	9/28/1996 9:58:00 PM
From: Brad C. Dunlap	of 1762

Hi Rick and Bennett, Coulter released the end of May 1996 at the ASCO conference the results of their phase I study of an anti-CD20 monoclonal antibody[anti-B1] labeled with iodine-131 in 34 patients with B-cell lymphoma who had failed chemo. Twenty eight patients received radioimmunotherapeutic doses resulting in complete remission in 14 patients and a partial response in eight. All 13 patients with low-grade lymphoma responded and 10 achieved a complete remission. It was the results of the low grade lymphoma that got alot of attention that caused an exaggeration in Idec's stock on the downside back in the summer along with weak mkt. conditions. You can read my earlier postings that I highlighted with Mr. Basu[Punk Zeigle analyst] comments. Time magazine recently had a special fall issue on the Frontiers of Medicine. There were know company names mentioned but did highlight Mark Kaminski and his remarkable success in lymphoma. Mark is the M.D. who is overseeing Coulter's clinics. In August Idec announced that they have innitiated a phase I/II study using C2B8 followed by YB28. In this release Idec was quick to mention how they had abandoned years ago the iodine-131 labeled antibody in favor of the Yttrium labled antibody. This was a jab directed at Coulter due to their aggressive statements of how their results are superior to Idec-C2B8. Last month there was an article on Coulter from the local Michigan newspaper were their studies were performed. The journalist had called Mr. Basu to get his take on the competitive battle between Idec and Coulter. Mr. Basu stated that Coulter will eventually be knocked out of the buisiness and does not stand a chance against Genentech/Idec's franchise of lymphoma products and strong financial backing in the lymphoma arena. Personally, I thought that was kind of aggressive but he could be right. If both products perform as before Idec-C2B8 should be the first to market the second half of 1997. Coulter's product should follow with approval sometime in 1998 and finally Idec YB28 in 1999. There are many advantages that an Yttrium labled antibody has over Coulter's product mainly less radiation and the ability to be administered in an outpatient setting. Earlier phase I studies showed similar success in the intermediated and high grade lymphomas and in this very small study patients were not pretreated with C2B8 like they will be in this new study. Bennett highlighted in an earlier post the advantages of yttrium. Only time will tell how the market will be shared but I strongly believe that C2B8 being that it is removed from the potential toxicities of radiation will be in great demand. I might also add that of the 34 patients in Coulter's study 6 developed HAMA which could be potentially negative in the eyes of the FDA. Bennett, I have had a few conversations with Idec on chronic lymphocytic leukemia and there are possible plans for a study sometime in 1997. CLL exhibits the CD-20 marker but i've been told that it is not as bright as compared to the marker in NHL patients. Otherwise CLL should be an idea target for Idec's antibodies especially due to the relative mildness of CLL as compared to NHL. I should emphasize that any cross prescribing is pure speculation on my part. However I have discussed this topic with a few practicing oncologists and it is a possibility.

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