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Biotech / Medical : Imclone systems (IMCL) -- Ignore unavailable to you. Want to Upgrade?

To: Fred Levine who wrote (1988)	2/10/2002 5:53:12 PM
From: dwight martin	Read Replies (2) \| Respond to of 2515

In the local Austin newspaper there is the story of a Mrs. Topfer who had pancreatic cancer two years ago but was able to get into an Erbitux trial. Just FWYTIMBW. I have never had any interest in IMCL. austin360.com "I told the oncologist when I first met him, that when I came to this hospital, I had a benign tumor that needed to be removed," she recalled. "Now I'm being told that I have inoperable, terminal cancer, and I don't accept it. It's as simple as that." (Ed. - Gee, if only . . . .) She insisted on having a hysterectomy to remove her ovaries. After that surgery, in November 2000, she was accepted into an experimental drug program at M.D. Anderson. The drug was Erbitux, which along with another drug, stopped the growth of her tumor. Erbitux has been in the headlines recently, * * * leaving little hope Erbitux will be approved in the near future."

To: Fred Levine who wrote (1988)	2/11/2002 12:43:19 PM
From: mact	Respond to of 2515

Well thats the point, the trial might not be valid...if they did not prove the pts were not responsive to irinotecan, than the response rate could have very well been caused by irinotecan...the trial arm was dumb imo...erbitux is no Gleevac against certain leukemias, in which there are complete responses and cures....even if you did get a 20% response rate, certainly doesnt mean it will translate into a survival benefit, which is the gold standard in oncology. I agree with you that the critical issue is whether IMCL adequately addressed the issue of whether the experimental pts. were refractory to the existing treatment protocol -- the standard. If this was not done, and IMCL admitted poor documentation, it must be done. I have no problem that Erbotux potentiates other chemotherapies, and may be ineffective alone. If giving Erbotux in combinations has an incremental clinical effect, IMO, that is sufficient -- if demonstrated by a valid experimental design.