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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (9110)	9/11/2003 4:29:07 PM
From: Icebrg	Respond to of 52153

Genta - Genasense trial After some further thoughts on the subject, this is how I believe (for the moment) that the recent PR from GNTA may be translated and understood. There are two distinctive groups in this trial. The company first set out to run the trial on 480 patients and later increased the number of participants with another 291. This gives the ITT-population of 771. When 537 events (i.e. deaths) had occurred the blind was broken and the results studied. In this analysis which was reported in the PR, 480 patients came from the first group for which enrollment started more than 12 months ago. The remaining 57 patients came from the late-starting cohort. It is probable that the relation between the two groups is not exactly the above. If there are survivors in the 480 patient group more patients from group 2 were included in the 537 events. In the group for which results have been studied for at least 12 months, the survival in the Genasense group is 10,1 months and in the placebo group 8,1 months. Here there is a statistically significant survival benefit. Combining these data with the results from the remaining 57 events brings down the survival and in the Genasense group and placebo group to 9,1 resp. 7,9. Does this indicate that the second group is in a worse condition than the participants in the first group? And that consequently GENTA will have a problem matching the results seen in the 480-group, when the results from the complete 771 ITT-group is analysed. I don't think this necessarily has to be the case. It is natural that the sickest people passes away first, while those who are stronger will live "longer". The first patients passing away in the second cohort will therefore most probably have had a negative results when added to the results of the first (12-months) group. As the remaining 234 patients i group 2 are passing away, they will be added to the survival time calculation. If they survive longer than 9.1 months the median survival time will increase etc. and vice versa. There is as far as I know no reason to assume, that there should be a difference in the survival characteristica between the two groups. I therefore think it is quite probable that the final median survival in the total ITT-population will be similar to the one seen in Group 1. One of the things that made Genta's PR so confusing was that they did not explicitly stated that the survival figures of 9.1 vs. 7.9 was derived from a smaller trial population of 537 patients. The PR doesn't give an n for this result. It is just referring to "all patients on an intent-to-treat (ITT) basis". The 537-number comes from the CC (I have been told). Erik