Osiris Therapeutics, Inc. (OSIR”>OSIR) recently provided an update on its stem cell therapy candidate, Prochymal. The company reported initial results from an interim analysis of an ongoing phase II study being conducted in newly diagnosed type I diabetes patients.
The study, which is being conducted in partnership with the Juvenile Diabetes Research Foundation (“JDRF”), is evaluating the safety of Prochymal in 63 patients. The study is also evaluating Prochymal’s ability to slow disease progression. Patients were randomized to receive either Prochymal or placebo.
While the one-year interim analysis showed that Prochymal was well tolerated with no differences in adverse event rates in the Prochymal and placebo arms, we note that there was no significant difference in the rate of disease progression in the two arms. The company, however, reported that a trend towards fewer hypoglycemic events was observed in the Prochymal arm compared to controls. The study will continue for another year following which the full data will be analyzed.
Besides being studied for type I diabetes, Prochymal is being evaluated for a range of indications including graft versus host disease, Crohn’s disease, acute myocardial infarction and acute radiation syndrome.
Osiris has a strategic alliance with Genzyme, a Sanofi (SNY”>SNY) company for the development and commercialization of Prochymal and another pipeline candidate, Chondrogen. While Osiris retained the rights to commercialize the candidates in the US and Canada, Genzyme has exclusive rights to commercialize Prochymal and Chondrogen in all other countries, except Japan, where Osiris has an agreement with JCR Pharmaceuticals. JCR Pharmaceuticals holds rights to Prochymal for the treatment of patients with hematological malignancies.
Neutral on Osiris
We currently have a Neutral recommendation on Osiris, which carries a Zacks #3 Rank (short-term Hold rating). While we are impressed with the company’s progress in cell-based therapies, we note that any pipeline setbacks would weigh heavily on the stock. In fact, we were disappointed with the company’s failure in gaining first round approval for Prochymal in Canada.
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