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: John Zwiener who wrote (32)	9/15/1996 12:36:00 AM
From: Brad C. Dunlap	of 1762

All suspision is appreciated and healthy when analyzing companies and more so when they are in the biotech industry. As far as a phase three study that is not blind being missleading is not necessary true. Genentech who is paying Idec $57 million in milestones, development funding and equity for the rights to market C2B8 has stated to me numerous times that their clincal procedures are very strong as far as following FDA protocol. AS a matter of fact at the American Society of clinical Oncology meeting held in May 1996, I do not recall hearing or reading any clinical abstract of any Non Hodgkin Lymphoma study that was a blinded study. At this meeting Idec released the first 50 patients of their phase III and I assure you it was not blinded nor scrutinized for not being blinded. Even Coulter pharmaceuticals {competitor] that I mentioned in earlier postings that got tremendous attention did not have a blinded study. I have reviewed hundreds of NHL studies since my involvement with Idec[most being chemo] and would be hard pressed to recall any blinded study. My speculation is that it probably is not humane to give a placebo to a patient with a potentially fatal cancer. I imagine you could blind the study without a placebo but probably would not be truely blinded. Most clinicals that I have followed have all been blinded but not necessarily so when dealing with potentially fatal cancers. Earlier this year Clinton and David Kessler[head of FDA] publically anounced that cancer drugs would receive fast track status and companies need only show tumor shrinkage in a phase II to receive FDA approval. Expensive phase III studies still must be completed but drug companies theoretically could have their drug selling concurrent with these studies. All cancer drugs are to be approved/dissaproved within 6 months of filling. Idec has surpassed all criteria of these new guidelines as well as the old criteria which focused not only on tumor shrinkage but duration of response. My reasoning for mentioning this is that Genentech/ Idec chose not to file early to ensure a high quallity and complete filling. I do understand the missprint that Bennett had in the previous post but understand the point that was made. That being that chemo can be quite toxic and may require hospitilization as compared to all of Idec's products that are designed to be administered in an out-patient setting. Lately, there has been much talk on Coulter's antibody that is labeled with Iodine-131. The results that were printed in July's issue of Journal of Clinical Oncology were very impressive, but do to radiation all patients were required to be isolated 2-3 days. This study was not blinded nor any of Idec's previous phase I,II and study done with chemo. One final note. The largest shareholder is SmithKline Beecham and the second largest is Genentech. I have seen many times were large companies make mistakes just like us, but I do believe they know more about Idec and how the clinicals are structured than any of us. Once again any insight pro or con will be greatly appreciated.

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