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news.Celgene Cellular Therapeutics, a wholly owned subsidiary of Celgene Corporation, has announced that the FDA has accepted the company's investigational new drug application to initiate a clinical trial using PDA001, an immunomodulatory therapy utilizing human placenta-derived stem cells obtained via the company's proprietary processes.
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Clinical development will begin by the end of the 2008 with the initiation of this Phase I, multi-center clinical trial in the US for patients with moderate-to-severe Crohn’s disease, who are refractory to oral corticosteroids, such as prednisone, and immune suppressants.
Celgene Cellular Therapeutics (CCT) owns an array of proprietary technologies directed to novel placental cell types and cell populations, as well as methods for collecting, processing and storing many types of stem cells from the placenta. PDA001 is said to be the first product to be developed as a result of this expanding portfolio.
Robert Hariri, CEO of Celgene Cellular Therapeutics, said: “This is the first step in our program to initiate clinical evaluations in a range of indications including not only Crohn’s disease, but other serious inflammatory and autoimmune diseases, such as multiple sclerosis and rheumatological disorders as well.”