How to Tell When A Drug Company Fibs About Clinical Trial Results
This Phase 2, multi-center, randomized, double-blind, placebo-controlled study is evaluating the safety and efficacy of Prochymal (ex-vivo cultured adult human mesenchymal stem cells) intravenous infusion following acute myocardial infarction. A total of 220 patients were randomized (1:1) at 33 centers in the United States and Canada and received a single intravenous infusion of Prochymal or placebo within 7 days following first acute myocardial infarction. In addition to screening and baseline visits prior to the infusion, initially follow-up evaluations were scheduled to be conducted through 2 years. Given the encouraging results observed at the one year time-point, the trial is being extended to include 5 years of follow-up. Both male and female subjects between 21 and 85 years of age were enrolled. Patients had to have a left ventricular ejection fraction (LVEF) between 20% and 45% as determined by quantitative echocardiography or cardiac MRI at least 24 hours after successful reperfusion of the culprit vessel. In addition, troponin levels must have been greater than 4 times the upper limit of normal during the first 72 hours of hospitalization for the MI.
Here is where Osiris describes the phase II study in detail but notice what is missing: Any discussion at all of the study's clinical endpoints!
Osiris had no such trouble describing the study's endpoints on March 2, 2011 in a press release announcing the completion of patient enrollment:
Efficacy endpoints determined from cardiac MRI include end systolic volume, LVEF and the ability of Prochymal to preserve functional heart tissue and limit scar formation following a heart attack. In addition, functional and quality of life assessments will be performed.
Osiris did not respond to an email request for the missing data from the heart attack study. The company also chose not to hold a conference call with investors following the release of the results Monday.
--Written by Adam Feuerstein in Boston.
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