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

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To: WWS who wrote (35)9/15/1996 1:55:00 PM
From: Brad C. Dunlap   of 1762
 
Bill, thanks for bringing this to my attention. I am aware of Immunomedics and read their press release the day it was released. The competition in the non hodgkins lymphoma arena is getting competitive. Other players are Idec, Coulter, Glaxo, Immunogen[IMGN], Techniclone[TCLN],Vical, and Genta. Most of these companies have compelling technoloy and are at different stages in their clinicals. I have highlighted Coulter due to impressive data and in late stages in their clinic. Actually, the most efficacious results have come from the studies at the Univ. of Washington, however they have been the most toxic requiring bone marrow replacements. I have not seen any of Immunomedics data but strongly beleive they are at very early stages in their clinicals. The attractiveness of Idec-C2B8 their lead product for low grade lymphoma is the data released thus far has been positive and consistant[phase I,II and a third of phase III ]. Idec-C2B8 is the only product in late stages whose mechanisms of action are removed from the potential toxic side affects of radiation. Coulter, techniclone.and the studies at the Univ. of Washington all use a form of radiation on their antibodies. This market is a relatively large and fast growing market and eventually there will be numerous players sharing varrious secters of the market. As we speak Idec is the farthest along in their clinicals,with good results and least side effects. The remaining portion of Idec's phase III study will be released at the AHS conference the first week in December. I will be attending to hear Genentech/Idec joint presentation as well as an opportunity to talk and listen to other NHL companies. Idec-Y2B8 is another product that performed well against the bulky intermediate and high grade lymphomas in a small phase I study. This is way to early for any excitement but as Bennet had mentioned is labeled with a radioisotope,yttrium. There are some huge advantages that would make this a compelling competitor in the intermedate and high grade lymphomas.
In the past 2 years much of the focus has been on Idec-C2B8 and rightfully so. As I mentioned earlier SmithKline is the largest shareholder and their interest lies in CE9.1 for rheumatoid arthritis. What we do know is SmithKline has unblinded a double blind placebo phase II study and observed positive efficacy vs. placebo. Exactly how good the results are will be released Oct. 19 at the ACR conference. As I mentioned earlier I have already paid my fee and will be there to hear the details. What I can report is that Eric Hecht MD.[biotech analyst at Morgan Stanley and 1995 wall street journal's pick as best perfoming biotech analyst in 1995] has had a conference call with SmithKline on the unblinding of the phase II study. His comments were that SmithKline not only wanted to see results better than the placebo but wanted to the results better than a 2 to 1 margin. He stated that he fully expects the release in Oct. to show impressive results and phase III trials to be initiated. There are other comments made that give me high confidence of a successfull clinic. Anyway, the next 3 months should be active and interesting.


Brad
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