Osiris to resume enrollment in Crohn's drug study

Osiris Therapeutics Inc said it is resuming enrollment of patients in a clinical trial to study its lead drug Prochymal in patients with treatment-resistant Crohn's disease, sending its shares up 5 percent in after-market trade.

Data from an interim analysis showed that for the primary endpoint of disease remission, the drug approached statistical significance in the intent to treat population, the adult stem cell research firm said in a statement.

The drug also reached significance in the per protocol population, it added.

Enrollment for the Crohn's program, consisting of two linked trials, was suspended last year over concerns over the trial design.

The decision to resume enrollment was made following discussions with the Food and Drug Administration about the results of the interim analysis, the company said.

Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract that affects almost one million people in the United States.

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