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Re: vinmantoo post# 180830

Wednesday, 07/30/2014 10:36:07 AM

Wednesday, July 30, 2014 10:36:07 AM

Post# of 251590
GALT> GR-MD-02 is administered by IV. Even if GR-MD-02 demonstrated efficacy, it would never have been a mainstream therapy IMO. If and when ICPT's OCA and/or Genfit GFT-505 reach the market there should be very few patients if any who will reach end stage liver failure due to NASH/fibrosis. GALT would be left with crumbs at best.

http://clinicaltrials.gov/ct2/show/NCT01899859?term=gr-md-02&rank=1

This study is a dose ranging study to assess in sequential fashion, the safety, tolerability, and dose limiting toxicities (DLTs) of GR-MD-02, in subjects with biopsy-proven NASH with advanced fibrosis. This is a dose escalation design comprised of 3 sequential cohorts to evaluate the safety of GR MD 02 when administered as a single IV infusion followed by 3 additional weekly infusions starting 28 days after the first dose. Each cohort will consist of 8 subjects, 6 randomized to receive active drug and 2 randomized to receive placebo.Based on data safety monitoring board (DSMB) and FDA review, 2 additional cohorts may be implemented, consisting of 8 subjects.


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