Prochymal phase II trial results

Osiris Therapeutics have announced encouraging results from their small trial of Prochymal in patients who had failed to respond to standard treatments.

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.

Comments were made by the lead investigator, Dr. Jane Onken:

“To understand the significance of this trial, it is important to appreciate just how sick these patients were,” said Dr. Onken. “On average, they had suffered with Crohn’s disease for 14 years and were unable to find relief with currently available therapy. It was in this difficult-to-treat population that we observed clinical improvement upon administration of the stem cell therapy.”

The Baltimore Sun had a talk with one of the participants of the trial:

The change, he said, began sometime in May, about eight weeks after he'd received an experimental stem-cell treatment developed by Baltimore's Osiris Therapeutics, which yesterday announced results of the 10-person clinical trial Gagne took part in.

...

"I have hopes, but I'll be very candid. I've been on other treatments as long as 13, 14, 15 months that worked reasonably well. The vote is still out on this," he said. "Right now, it's probably the best treatment that I've ever had based on the results that I've achieved, but [I'm waiting to see] if it works like this for, let's say, 15, 16, 24 months."

The Baltimore Sun has further details in their business section.

Prochymal, which Osiris says interacts with immune cells to reduce inflammation and aid tissue repair, already is in late-stage trials as a treatment for a rare inflammatory condition associated with bone marrow transplants. If approved, it would likely be the first pure stem cell product on the market.