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Biotech / Medical : sciclone pharmaceuticals
SCLN 11.150.0%Oct 20 5:00 PM EST
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To: JEB who wrote (927)8/26/2001 5:35:33 PM
From: Oak Tree  Read Replies (1) of 1137
 
JEB,
The first question is a very long one so I'll only answer part of it -- namely the question of what is a phase I study (as compared to a phase II or phase III).

The study was a phase I study. Hence the endpoint is not response it is toxicity. In a phase I study, this sounds funny, the objective is to see how much drug causes toxicity. At the end of a phase I study you know the maximum tolerated dose. This is called the the MTD.

A phase I cannot answer the question as to whether a drug works. It is not powered or designed for that. Nevertheless, they made statements regarding response based on the phase I (everybody does even though they shouldn't).

They have and continue to overstate their results beyond just overstating a phase I study -- for example twice a day radiation (used on the last 3 patients has been shown to be better than once a day). Its ok to change the radiation (you shouldn't but its ok) in a phase I study, since the endpoint is toxicity not response. BUT you shouldn't say that the last three patients did better and it was because they got the higher C225 dose -- they also got the twice a day radiation.

Ill talk about phase II and phase III studies some other time. Here again, on their so called phase III study of chemotherapy resistant cancer the design was flawed.

I am very concerned about the integrity of IMCL. They are bending the rules and boardering on dishonesty. Some of the principle stock holders include physicians that control some of the largest oncology centers in the country. When this one goes down -- it could be a real spectacle.
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