Canada Approves Prochymal, World’s First Stem-Cell Drug

Canadian health regulators have approved the world’s first stem-cell drug for children, according to Osiris Therapeutics Inc.

According to Reuters, the company released a statement on Thursday, which stated that the regulators approved the treatment for “acute graft-versus host disease in children.”

The Digital Journal reports that Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada stated in a press release:

“I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope.”

Graft-versus host disease (GvD) occurs after a patient goes through a bone marrow transplant. The Digital Journal reports that the disease will kill about 80 percent of the children who are infected.

According to Newser, the drug is called Prochymal, and in trials, it helped a subgroup of patients, who saw an improvement in 61% to 64% of cases.

Daly, the Principal Investigator of Prochymal, went on to say that:

“As a result of Health Canada’s comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920’s, with stem cells we have now officially taken the first step into this new paradigm of medicine.”

C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris also praised Canada’s decision, stating:

“Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies. Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last.”

Osiris Therapeutics Inc plans to seek F.D.A. approval for Prochymal later this year.