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Biotech / Medical : biotech firesales
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From: tom pope1/24/2006 9:49:09 AM
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CRIS:

To date, 29 of the Phase I clinical trial patients have participated in a dose-escalation segment, in which seven patients were randomized to receive treatment in one of four dose levels. The dose-escalation segment of the Phase I clinical trial was recently completed, and the preliminary data have been reviewed by an internal Genentech data review board. The preliminary data from the dose-escalation segment suggest that the drug candidate appears likely to be safe, well tolerated, and has shown signs of activity. However, there has been less clinical activity observed to date than anticipated. Based on these data, the internal data review board recommended that Genentech and Curis temporarily suspend further enrollment in the second segment of the trial, in which additional patients were to be treated at the highest dose level from the dose escalation segment. The companies will determine to re-open enrollment in this segment based on a secondary interim analysis that will occur at a later date. The internal data review board also recommended that a third segment of the trial that is evaluating biological activity using a pharmacodynamic endpoint be enrolled as planned. This third segment, among other things, may shed light on the extent to which the active compound in the drug candidate as formulated is penetrating the patients' skin.
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