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: Miljenko Zuanic who wrote (651)	4/16/1997 6:17:00 PM
From: Brad C. Dunlap	of 1762

Hi Miljenko, there is no doubt that monoclonals have their place for acute diseases but it should be very interesting to see how they progress in the chronic therapies. It appears that CE9.1 which attracted SmithKline and huge $ commitment and has progressed passed 2 phase II clinicals with much enthusiasm and now well into the phase III is off to what appears to be a darn good start and will soon be approaching the finish line. Lets face the fact that the RA mkt is very large and the competition is very intense. Immunex presented very positive data and is definantly a serious contender to capture mkt share. Amgen also presented what appeared to be very exciting data and the ACR thought so as well but they failed to excite the rheumatologists after question and answer session. Centocour's monoclonal for RA appeared to show good results but certainly was not as impressive. If I recall correctly they used their product in conjunction with methotrexate which has the potential for serious side effects. Antisense reads well in theory but way to early to get excited and certainly I have not seen any exciting large human studies that support to the contrary. I do know that at the time of the ACR conference that Idec and Smithkline were very excited about results that were not published on retreats and at that time were receiving longer duration of responses on the retreats. Once again it is to early to tell but Idec's primatized antibodies appear to be passing the tests put in front of them. As far as Idec's pipeline is concerned this IMO is very exciting. C2B8 filed NDA for low grade nhl should be very attractive for nhl patients currently faced with either chemo or radiation for therapy. Chronic lymphocytic leukemia could be another target for C2B8 according to DR Rai at his presentation at the American society of hematologists, who is foremost authority on CLL. CLL and NHL very closely related and with new cancer initiative for approved drugs the potential studies to support approval should be abbreviated. YB28/C2B8 for intermediate and high grade lymphoma which is in phase II and phase III is projected to be initiated by the end of the year should be a powerful combination. We've discussed CE9.1 which is in phase III. Also the small molecule products that Idec recently acquired for multiple cancer in phase II is something to watch in the future. CE9.1 is also being tested for a particular type of asthma that has been kept very quiet but when Bill Rastetter comments publicaly that we have exciting results I have learned how to interpret this familiar comment. This I believe to be a relatively small market but has been kept quiet by Smithkline. There are 3 products in preclinicals all of which are funded by large partners up to$75 million and expect 2 IND later in the year. This added to their proprietary mamalian cell manufacturing that they have licensed to a handful of larger companies makes for a potentially very exciting future. I just heard that Idec announced that todays selloff is directly related to the partnership of ML/MS. Hopefully this will take some of the uncertainty out of today's poor showing. In summary, all drugs have the potential for serious side effects and more so for drugs that haven't made it as far as CE9.1. Smithkline knew years ago about the potential side effects of repeated uses of monoclonals and chose Idec CE9.1. Now that it is a few years later and very positive data to date certainly sounds exciting. Also from my understanding Centocours anti-cd4 MAB actually depletes the T helper cells from the circulation and lymphid organs altogether. Idec's seems to cause the CD4 protein to disappear from the cell surface for up to 3 weeks. This temporarily disabling of the T cells by CE9.1 and the fact that Centocour depletes the T helper cells, could be why Centocour MAB was not used as a stand alone therapy.

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