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sfruehling1 3 posts  |  Last Activity: May 12, 2014 12:49 PM Member since: Feb 15, 2008
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  • sfruehling1 sfruehling1 May 12, 2014 12:49 PM Flag

    Correct. It should have said Phase 2 instead of Phase 3.

  • sfruehling1 sfruehling1 May 11, 2014 8:16 AM Flag

    Summary & Conclusion: Athersys' Phase 2 on ulcerative colitis (750 million cells) appears similarly powered on a cell dosage basis to the Phase 2 study by Osiris on Crohn's disease (175 M to 700 M cells). Osiris' Ph 2 showed statistically significant efficacy, while Athersys' study did not. This suggests to me 1) MultiStem is not as powerful as Prochymal or 2) effective treatment of ulcerative colitis with stem cells may be different than the effective treatment of Crohn's disease, or 3) the Phase 2 of Osiris may be so small (9 patients) and insufficient (e.g. no placebo) to not be a reliable indication for effectiveness. I am hopeful, but not optimistic, Athersys' 16-week data & other data not yet reported will show at least some signs of efficacy. At 4 weeks, the proportion of responders on MultiStem was significantly greater than placebo but the benefit was offset by declines in a minority of MultiStem-treated patients such that overall benefit at all time points measured was not significant. If there is at least some show of effectiveness in Phase 2, Pfizer might do another Phase 2 or a 3 using a higher dosage.

  • Osiris' Phase 2 study on Crohn's disease (9 patients, placebo- no) used one dose (8 million cells/kg or 2 M cells /kg) of Prochymal on day 1 and another dose in 1 week. All patients showed improvement at week 4, the study's major efficacy endpoint. Effectiveness appeared dosage strength related. Assuming an average body weight of 190 lbs, a high dose of Prochymal comprised about 700 million cells and a low dose 175 million cells. Osiris' Phase 3, Part 1 (Protocol 603), study on Crohn's disease (270 patients, placebo- yes) used a high dose of 1,200 million cells (two initial 400 M cell injections followed by two 200 M cell injections within 2 weeks) and a low dose of 600 million cells (two initial 200 M cell injections followed by two 100 M cell injections within 2 weeks). Results of Phase 3 expected by the end of the year.

    Athersys' Phase 2, Cohort 3, study on ulcerative colitis (88 patients, placebo- yes) used one dose of Mulitstem on day 1 and another dose in 8 weeks. Patients getting MultiStem did not show any significant clinical remission or response in comparison to the placebo group at 4 and 8 weeks. The study's primary efficacy endpoint was at 4 & 8 weeks. Of the 88 patients, 48 patients received a high dosage of 750 million cells (1st qtr CC, 48 min) & 40 patients received a placebo. Prior to dosing of the 88 patients in Cohort 3, 5 patients in Cohort 1 (an initial small & safety portion of Phase 3 & not powered for efficacy) received a low dose (# of MultiStem cells not known) on day 1, 1 week, and 2 weeks. Cohort 1, 2, and any sixteen-week data of Phase 2 have not yet been reported.

    Sentiment: Buy

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