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

To: Icebrg who wrote (9081)	9/10/2003 12:32:02 PM
From: Icebrg	Read Replies (3) \| Respond to of 52153

Genta - Some help and explantaion wanted. There is something I don't understand here. Please, help me. Genta wrote as follows today. The Phase 3 trial enrolled patients at 140 sites from 12 different countries. A total of 771 chemotherapy naove patients were randomly assigned to receive dacarbazine (a standard chemotherapy drug) alone or in combination with Genasense. The primary endpoint of this trial was to compare the overall survival between the two treatment arms. Secondary endpoints included comparative analyses of progression-free survival and tumor response. The following results were obtained: * Analysis of all patients on an intent-to-treat (ITT) basis showed that the addition of Genasense to dacarbazine resulted in a median survival of 9.1 months, compared with 7.9 months for patients treated with dacarbazine alone (P=0.184). * For patients treated per-protocol who have completed a minimum follow-up of 12 months (N=480), the addition of Genasense resulted in a median survival of 10.1 months, compared with 8.1 months for dacarbazine alone (P=0.035). * For the ITT population (n=771), patients treated with Genasense plus dacarbazine showed a significant increase in median progression-free survival to 78 days, compared with 49 days for patients treated with dacarbazine alone (P=0.001). * For the ITT population (n=771), patients treated with Genasense plus dacarbazine achieved an antitumor response rate of 11.7% (using RECIST criteria), compared with 6.8% for patients treated with dacarbazine alone (P=0.019). * The addition of Genasense to dacarbazine did not appear to be associated with serious, previously unreported adverse reactions compared with the use of dacarbazine alone. Now to my question. What does N=480 stand for? It cannot be the number of patients in the sample, as there were not 480 survivors at 12 months. And how could there be an minimum follow-up period of 12 months, when the median survival in this group was less than 12 months. Does the observation period starts at enrollment and the starting point for the survival calculation at a later date, or....? Erik