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Biotech Stock Mailbag: Mela, Osiris, Talon

Osiris' SEC filings make no mention of the study. ClinicalTrials.gov, the database that is supposed to list all past and current drug trials, has no listing for this Grafix study. An ongoing "phase IV" reimbursement study of Grafix in diabetic foot ulcer patients is listed.

I asked Osiris to provide the Grafix data from the "pilot trial" described by Mills. The company didn't respond to my request.

Osiris' Web site has no information either, except for a press release dated April 14, 2011: "Osiris Therapeutics Wins Top Scoring Abstract at the 24th Annual Symposium on Advanced Wound Care".

In this press release, Osiris describes an abstract presented at the meeting titled "Limb salvage utilizing a human mesenchymal stem cell-containing skin substitute: results of a case series in patients with diabetic foot ulcers." Emphasis mine.

A case series is not the same as a clinical trial, it's not even a "pilot trial." A case series simply describes treatment and outcome in anecdotal terms and carries very little clinical or regulatory significance.

It gets even worse for Osiris. I was able to obtain a copy of this abstract independently. It describes four diabetic foot ulcer patients treated with Grafix, not the 60 patients claimed by Mills. "Complete wound closure" occurred in all four patients after a median of 17 weeks of treatment -- an entirely unremarkable result particularly since these patients were likely handpicked by the treating physician to solicit the best response possible. There are no control patients to compare against Grafix in the case series.

If you're interested in learning how a legitimate company conducts a real diabetic foot ulcer clinical trial, check out the strong results posted by Derma Sciences (DSCI) from a phase II study of its experimental wound-healing drug DSC127.

So to recap: Mills stood in front of investors on July 13 and boasted about the wound-healing attributes of Grafix based on a 60-patient study in diabetic foot ulcer patients. But after some fact checking, the 60 patients were actually four patients and the "pilot trial" was really just an anecdotal "case series" report.

And on this flimsy foundation of fluff, Osiris expects to build a meaningful biosurgery business with Grafix? Good luck with that.

Meantime, I'm still waiting for Mills to explain why he hasn't released data on the true primary and secondary endpoints of the Prochymal heart attack study. Osiris also hasn't responded to allegations from investigators involved in the heart attack study that they've been kept in the dark about the data.

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