IDPH--Positive preliminary results for pivotal trial of ID Message Board

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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: Brad C. Dunlap who wrote (957)	6/5/1997 8:40:00 PM
From: I. Luttichuys	of 1762

Hello Brad, I do not appear to have received that e-mail but, you present post here is most useful and the content is quite encouraging. I have seen the T-cell data that you present here. It has been available for some time and to me, certainly it has always been viewed as being very innocuos as compared to both the prevalence and seriousness of some of the side-effects seen with at least some of the steroidal alternatives. Since we are talking about T-cell counts, I wonder if you might have information or precedence available to you on the FDA's stance on what sort of T-cell effects are considered acceptable relative to CE9.1's indicated use. The numbers you cite are good and the timing of SmithKline's sales as it stands with respect to the study are encouraging. I only wonder about the FDA's tolerance for T-cell effects in a drug intended for RA for the point of discussion. The effects for the vast majority of patients disappear with return to baseline within what seems to me a very reasonable window and the very few who do not eventually do with the exception of 2 (at least at the time of the presentation of this data). One assumes that if T-cells were a concern and CE9.1 were approved, it would be a simple matter to monitor patients to ensure they would respond to CE9.1 safely and in the way that the vast majority of patients do. There are plenty of approved drugs on the market for which monitoring for various reasons is required. Still, does anyone know how the FDA, for example, views this data? Thanks for the post, Brad. It is difficult to believe SmithKline would be afraid of something to do with a study which is still blinded as per your contacts and as of yesterday. BENNETT

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