Prochymal failed to go past late-stage clinical trials
Prochymal, which was developed by Osiris Therapeutics, as the world’s first drug derived from human stem cells has failed to live up to the expectations. The failure of this drug in the two late-stage clinical trials proved to be a setback for developer of this drug.
It was remarked by Osiris Therapeutics that Prochymal is not more effective than a placebo for treating life-endangering complications concerned with bone marrow transplantation though there may be some patients who may still benefit with Prochymal.
As soon as the news broke out, shares of Osiris went down tumbling by 34 percent to $8.03.
From NYTimes.com:
Prochymal is a preparation of mesenchymal stem cells, which are obtained from the bone marrow of healthy young adults.
Because the cells are derived from adults, they sidestep the ethical issues stemming from the destruction of human embryos needed to make embryonic stem cells. Unlike most other types of adult stem cells, mesenchymal cells grow well in culture, so thousands of doses can be produced from a single donation.
Stem cells, particularly in the form of bone marrow transplants, are already used in medicine. Osiris is hoping that Prochymal will become the first stem cell product approved by the Food and Drug Administration and sold as a mass-produced pharmaceutical product.
But the failure in the two trials could make it hard to reach that goal. Both trials tested Prochymal as a treatment for graft-versus-host disease, which occurs when immune cells in donated marrow attack the recipient’s organs as foreign tissue.
In one trial where Prochymal was combined with steroids, 45 percent of patients responded well against 46 percent of patients on a combination of placebo and steroids. In the second trial, the drug was tested in patients who have failed to derive any benefit from steroids. It was noticed that 35 percent of those getting the drug had a resolution of graft-versus-host disease for at least 28 days as compared with 30 percent for those receiving the placebo.
Tags: human stem cells, mesenchymal stem cells, Osiris Therapeutics, Prochymal, Steroids
Recent Comments