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Politics : Ask Michael Burke -- Ignore unavailable to you. Want to Upgrade?

To: Knighty Tin who wrote (94572)	2/21/2002 12:49:28 PM
From: JHP	Read Replies (1) \| Respond to of 132070

By: thboomsparkle $$$$$ 21 Feb 2002, 03:30 AM EST Msg. 41585 of 41595 (This msg. is a reply to 41558 by amber_214.) A Key Dr. Folkman take home message: adequate 24/7 doses of ES work Excerpts RE Endostatin patients from Dr. Folkman’s 2/19/02 speech--this is my transcription from the audio, as close as I could get it, with my own underlining & highlighting: A drug that produces "Stable Disease" in chemotherapy means failure to most oncologists, is anathema to large pharmaceutical companies, and at the ASCO meetings, journalists will report it as ‘failed to meet expectations’. The wire services, to save room, just report, ‘failed.’ Why? Oncologists know and patients know that Stable Disease cannot be maintained for a very long time, usually 6 months or 8 months, and then drug resistance develops . . . But the worst thing is that Stable Disease comes at a cost of significant side effects including most commonly loss of body hair, diarrhea, weight loss, and bone marrow suppression. If you contrast this with a patient that has rapidly progressive metastatic cancer and goes on an angioinhibitor at an effective dose, and I’ll use Endostatin as an example, because I have personal experience with it. I don’t supervise the trials, but I see the patients every two weeks in the clinic, and I’ve been doing that since the trial started. What one sees is the following: you have a patient with an effective dose, their hair grows back, appetite returns, 10 or 20 pounds weight gain, bone marrow returns to normal, the diarrhea stops, they no longer wretch at night, no drug resistance so far, and they refuse, as a group, to use the term "Stable Disease", because their friends offer condolences—their friends have seen cancer patients. If you have had chicken pox, you have the zosta herpes virus in your lower spinal cord for life. Doctors say we have ‘infection without disease’. If you change ‘infection without disease’ to "Stable Disease", people are much less comfortable. You can’t appreciate what "Stable Disease" means to these patients. They say they have ‘cancer without disease’, and they won’t use " Stable Disease". The chemotherapy patients come to the clinic in an ambulance in their bathrobes with an emesis basin, while the Endostatin patients come to the clinic on the street car with their shopping bags because they're just picking up their drug, and are going to go on and take it at home. . . . . . Oliver Kisker just published a study with mice showing Continuos Infusion of Endostatin was vastly superior to an identical dose delivered once a day via bolus IV. At a low dose of 1ml/hour via Continuos Infusion, tumor growth slowed 68% vs. only 33% when an identical dose was administered via bolus IV. At a higher dose of 3ml/hr, Continuos Infusion Regressed the tumors, vs. only a 66% slowing delivering the higher dose via bolus IV. That has been the experience of the first patients on Endostatin who were first on 30 minute bolus IV for 6 months, then Continuos Infusion, and now Sub-Cutaneous Injection. . . ********************************* The first Endostatin patients Dr. Folkman is referring to who are now apparently converted to Sub-Cutaneous Injection are from the 12 patient DFCI ES Phase I Extension Trial. The patients in this group are the first to have an opportunity to receive a potentially therapeutic dose of ES 24/7. In ENMD's 11/7/01 conference call, all 6 of the patients in the 60mg/ml dose arm were reported to have Stable Disease at four months, with 2 having been on trial for over 1 year. At 11/7/01, none of the 6 patients in the higher 240mg/ml dose arm had qualified to convert from bolus IV to Continuos Infusion (the patients were required to start w/ bolus IV for at least 2 months, and then were eligible to convert to CI if their tumor mass hadn't increased over 50%). ENMD will be reporting the results of this trial extension at the upcoming 5/02 ASCO. (Voluntary Disclosure: Position- Long) - - - - - View Replies »