Update: Investigators in the Prochymal heart-attack study accuse Osiris Therapeutics (OSIR - Get Report) of announced preliminary results without their input or consultation, according to Larry Husten of the CardioBrief news blog.
"I have heard from several investigators in the trial that the Osiris press release was issued without any input or consultation from the site investigators. In fact, the site investigators, including several who are extremely experienced clinical trialists, have expressed frustration and disappointment because their input has not been sought at any point during the trial."
Husten's reporting adds weight to the allegations first raised earlier this week that Osiris misled investors when it announced results from a mid-stage study of its stem cell therapy Prochymal in heart attack patients. Osiris claimed heart attack patients benefitted from Prochymal but the company failed to disclose key primary and secondary endpoints of the study.Investigators from hospitals who enrolled the largest number of patients in the Prochymal study told CardioBrief's Husten that Osiris has kept them in the dark about the design and conduct of the study. Furthermore, the study's steering committee, which is supposed to oversee the study, has not seen the Prochymal data. Husten: "In fact, steering committee members were not even aware that Mark Vesely, an assistant professor at the University of Maryland, was the principal investigator of the study. One steering committee member said he’d never heard of him before reading the press release." Officials with the University of Maryland have not returned a phone call seeking comment. The full story on Osiris and its Prochymal heart-attack study, as published July 3, is below: COLUMBIA, Md. ( TheStreet) -- Osiris Therapeutics (OSIR - Get Report) "disappeared" important data when the company announced results Monday from a mid-stage study of its stem cell therapy Prochymal in heart attack patients. Naturally, Osiris didn't come out and tell investors that it was issuing a misleading press release on the Prochymal heart attack study. Instead, the company claimed the study was a success. That's not true. Figuring out Osiris' deception wasn't that difficult if you know how to parse the language of clinical trial results and look at independent sources of information for the truth. Ride along with me as I pick apart Osiris' statements regarding the Prochymal heart attack study. Interpreting clinical trial results with a skeptical eye is a crucial tool for all biotech investors, so apply these skills universally whenever a drug or biotech company tries to convince you that its drug works. Hopefully, you'll find most companies are telling the truth, but sadly and too often, bullish pronouncements about boffo clinical trial data are just spin jobs ginned up to plaster over problems and bad data. Here's what Osiris issued Monday: Osiris Therapeutics, Inc. announced today interim one-year results from its groundbreaking clinical trial evaluating Prochymal (remestemcel-L) for the treatment of patients experiencing first-time acute myocardial infarction. The trial is the largest study of allogeneic or "off-the-shelf" stem cells ever conducted in heart attack patients. A total of 220 patients were given a single infusion of either Prochymal or placebo through a standard intravenous line within seven days of an acute heart attack. Not much to quibble with here except it's helpful to know that Osiris enrolled the first heart attack patient to this study in April 2009, so it took more than three years to complete and report "interim" results. ClinicalTrials.gov
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