Biotech Stock Mailbag: Mela, Osiris, Talon
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.
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.
Patrick K. asks: "Can you help me interpret the new Vertex Pharmaceuticals' (VRTX) hepatitis C drug data? Will this drug replace Incivek and what does it mean for Gilead Sciences (GILD) , Idenix Pharmaceuticals (IDIX) and some of the other companies trying to develop hepatitis C drugs?"
I find it fun to reduce biotech news to musical terms, so when I first saw the new Vertex Hep C data on Monday, my first thought was LL Cool J's seminal rap "Momma Said Knock You Out."
"Don't call it a comeback!"
Vertex is still very much in the Hep C game. The company's experimental drug ALS-2200 (at the highest dose tested) yielded a 4.54 log10 reduction in viral load after seven days of dosing in genoytype 1 hepatitis C patients. ALS-2200 wasn't studied directly against similar Hep C "nucs" in this pilot trial but, naturally, that isn't stopping investors from making their own comparisons. The potency of ALS-2200 stacks up quite well compared to Gilead Sciences' much beloved GS-7977 (4.5 log10 reduction after seven days) and Bristol-Myers Squibb's (BMY) BMS-094 (4.25 log10 reduction after seven days).