Osiris Therapeutics said that it has been granted Orphan Drug status from the U.S. Food and Drug Administration (FDA) for its Type 1 diabetes treatment called Prochymal. Such a designation is used to help promote treatments for diseases that affects fewer than 200,000 new patients each year.
Prochymal, is a stem cell treatment that seeks to control inflammation, promote tissue regeneration and prevent scar formation. The drug is being evaluated in a Phase II clinical trial for Type 1 diabetes.
Type 1 diabetes is an autoimmune disease in which the body’s immune system mistakenly attacks its own insulin-producing beta cells and destroys them. Some research suggests that stem cells may be able to slow the destruction of such cells in people with Type 1 diabetes. The current study is evaluating the safety and effectiveness of the treatment on newly diagnosed diabetics age 12 to 35.
The stem cells being used are harvested from bone marrow of healthy donors.
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