MGI Pharma MOGN New patents, anti cancer Message Board

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Biotech / Medical : MGI Pharma MOGN New patents, anti cancer

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To: Miljenko Zuanic who wrote (183)	9/13/1997 7:51:00 AM
From: David Cathcart	of 1826

MZ The data in my reply to you was taken from Joseph von Meister. Joe regularly talks with MGI management and the doctors conducting the clinical trials. His information on the trials is current and I trust him (you know me...the trusting one :-)). The NCI will not get involved with MGI 114 until it enters phase II, at which point they will sponsor 13 separate trials. I assume that is why you were unable to locate the protocol. If you look back on my posts for the last week or so, you will see that I am also questioning the human/animal dose equivalently factors for MGI 114. Others have yet to shed any light on the issue. However, I am surprised that your calculations show the dose to be so relatively low. While the Richards are better qualified to respond to this issue, I would say that it is not appropriate to compare dose levels of MGI 114 with the inadequate therapies currently approved. MGI 114 has "a unique mechanism of tumor killing action" and thus such a comparison is apples & oranges. On August 22nd I had a conversation with Chuck Muscoplat regarding the second phase I study and posted what was said. As I think back to the conversation, I realize that I left one thing out of the post. The reason for changing the dose regimen is that, at the original 5-minute infusion, there was beginning to be some minor vein irritation at the point of infusion. Changing the infusion time to 30 minutes (same total amount of drug) is expected to alleviate that symptom. This will likely be increasingly important as the dose level escalates. He reiterated that they are experiencing no significant side effects at the current dose. Muscoplat said during the teleconference at the end of the last quarter that the dose level in phase I was already beyond the point where they would be comfortable entering phase II. Remember that they have already seen three cases of efficacy - against highly aggressive and therapy resistant tumors - and they have yet to reach MTD. Richard says MGI 114 is a billion-dollar drug. I think he is right until proven wrong. :-) David

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