DAVID GRANOVSKY

Osiris – FLASHBACK to Sept, 2009

In BUSINESS OF STEM CELLS on July 26, 2010 at 6:07 pm

I think this paragraph from Sept 2009 is as true today as it was almost a year ago -dg

Certainly major pharma companies are tracking the news flow from Osiris closely. Keenly aware that they got into the biologics game too late, but nonetheless wary of the incredibly complicated biology involved, Big Pharma is in a state of cognitive dissonance when it comes to stem cells. “They’d like to see a true product,” Giebel says, noting that the preference is for allogeneic therapies, “because one size fits all.” The problem with creating an allogeneic therapy, which arguably could be treated as a product in the traditional pharma sense, is that the stem cells are derived from someone other than the ultimate recipient, bringing into play the challenge of immune response. (Mesenchymal stem cells are unique in that they are not “seen” by the immune system and in fact have the effect of down-regulating T-cells, making them potentially effective in autoimmune indications, like GvHD.)


Osiris Hiccup In COPD Barely Registers In Stem Cell Sector

…Lazard analyst Joel Sendek, for example, advised investors to wash their hands of the company, based on the COPD slip and earlier troubles with a clinical trial in Crohn’s disease that resulted in a high placebo response. But for the most part, investors and analysts shrugged off the data, choosing to view it as a learning experience in a secondary indication, while keeping their eyes focused on the pending GvHD results.

It would have been nice to see Prochymal succeed in COPD because that’s a very large market, “but is it a major setback? I don’t think so,” says Lutz Giebel, PhD, a managing partner at SV Life Sciences. Giebel co-founded the embryonic stem cell company CyThera Inc. in 1999; the biotech merged with another SC company, BresaGen Inc., in 2004 to form Novocell Inc.

Certainly major pharma companies are tracking the news flow from Osiris closely. Keenly aware that they got into the biologics game too late, but nonetheless wary of the incredibly complicated biology involved, Big Pharma is in a state of cognitive dissonance when it comes to stem cells. “They’d like to see a true product,” Giebel says, noting that the preference is for allogeneic therapies, “because one size fits all.” The problem with creating an allogeneic therapy, which arguably could be treated as a product in the traditional pharma sense, is that the stem cells are derived from someone other than the ultimate recipient, bringing into play the challenge of immune response. (Mesenchymal stem cells are unique in that they are not “seen” by the immune system and in fact have the effect of down-regulating T-cells, making them potentially effective in autoimmune indications, like GvHD.)

Meanwhile, autologous therapies, in which the patient’s own cells are collected, treated, and put back in, are more transplant than therapy, and not an appealing acquisition for pharma in Giebel’s opinion. But given the nascent state of the field and as yet no clear clinical success stories, there are many others with divergent views.

via BioPharma Today: Osiris Hiccup In COPD Barely Registers In Maturing Stem Cell Sector.

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