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Biotech / Medical : Lidak Pharm. [LDAKA]

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To: John Zwiener who wrote (249)	7/9/1997 10:36:00 AM
From: luis a. garcia	of 1115

I don't have much feel for when they should or should not report progress with LMI.. I know in my work which is different from theirs.. I need to look at data in different ways etc to be able to formulate an analysis.. LMI work is tricky because you are dealing with malignant melanoma patients and the disease can be all over the place etc and you are projecting where is going and then you are trying to determine if you made a difference and arrested its progress statistically significant to show efficacy...of treatment. For a first trial in which you don't even have the process down as to how you will determine all this...and what patients have secondary issues that will cloud your results etc.. I don't see how anybody can predict WHEN progress report is due to come out one way or the other.......Many experiments need to be run and the interactions need to be considered... etc... This is not baking cookies John ..pop'em in the oven for 15 minutes etc... but please gang teach me and disabuse me of any ignorance.. for it costs money to be ignorant. this is the company blurb """" A total of 17 patients, one with stage three and 16 with stage four malignant melanoma, completed the Phase 1/2 clinical trial which was conducted by Dr. Malcolm S. Mitchell, Director of the Center for Biological Therapy and Melanoma Research at the Cancer Center of the University of California, San Diego. Criteria for the study conformed with the staging system adopted by the American Joint Committee on Cancer and defined stage three melanoma as limited nodal metastases and stage four as advanced regional metastases or any patient with distant metastases. This clinical trial was designed to examine primary endpoints of safety, tolerance and to determine the optimum biological dose of LP2307. The efficacy of the study will be evaluated as a secondary endpoint with consideration for an expanded trial. The study design called for three groups of six patients. The patients in each group received three monthly injections at one of three dose levels, with each patient being followed for a total of four months. LP2307 at all of the dose levels was well tolerated and five of the patients in the study continued treatment beyond the four month initial phase. LIDAK anticipates having a final analysis of all of the study endpoints by the end of the third quarter of 1997."""" luis

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