Indications -- Hepatitis Message Board

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Biotech / Medical : Indications -- Hepatitis

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From: DewDiligence_on_SI	11/11/2008 7:49:06 PM
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Re: Tidbits on the all-oral HCV cocktail ITMN’s Dan Welch gave some tidbits on the INFORM-1 trial of ITMN-191 plus R7128 during today’s DB webcast: 1. The trial sites are in Australia and New Zealand because the FDA (and presumably the EMEA) did not approve of a trial with two experimental agents until each agent was already in phase-2. By mid 2009, each of the agents (ITMN-191 and R7128) will be in phase-2, allowing trials to begin in the US (and presumably in Europe). 2. Two-week results from INFORM-1 should be available in time for reporting at EASL in April. 3. After two weeks on ITMN-191 + R7128, patients will continue with 46 weeks of SoC (a total treatment duration of 48 weeks). Patients will be tested for RVR, EVR, and SVR. (Although two weeks of treatment with ITMN-191 + R7128 may be less than optimal, the above metrics, especially RVR and SVR, will nonetheless be considerable interest.) 4. The exact dosing protocol in the trial is being kept a secret (at Roche’s behest); however, Welch said at least four different ratios of the two drugs will be tested. 5. From the questions by the analysts on the webcast, it’s clear that INFORM-1 is a hot topic among those who follow the HCV arena with even a modicum of interest.

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