Friday, June 27, 2008

Osiris Therapeutics has started a Phase II trial

Osiris Therapeutics has started a Phase II trial of their Prochymal cure for type-1 diabetes. This is an adult stem cell based cure, which has already completed Phase I and II trials and is undergoing Phase III trials targeting other immune diseases, such as Crohn's and Organ Rejection, etc. I think it is being tested on 6 or so different diseases right now. The company's description is this: "Prochymal is a preparation of mesenchymal stem cells specially formulated for intravenous infusion. The stem cells are obtained from the bone marrow of healthy adult donors."

The trial is 60 people, all within 16 weeks of initial diagnosis. It started in June 2008 and is expected to end in June 2010. The study is being done in Tennessee, and is partly funded by JDRF. Here is the company's description: "The design will be a double-blind, placebo-controlled trial at multiple sites with a target enrollment of 60 patients, and patients will be randomized to either Prochymal or placebo at a 2:1 ratio. The primary endpoint of the trial will be the measurement of C-peptide produced during a Mixed Meal Tolerance Test in patients treated with Prochymal, compared to those receiving placebo."

As far as I know, this is the first Phase II human trials for any stem cell based cure for type-1 diabetes. So it represents a whole new approach to a cure, into Phase II trials. Very good news.

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