Encouraging results from CCT's Phase I study of PDA-001 for treatment-resistant Crohn's Disease

Apr 9 2010

Celgene Cellular Therapeutics (CCT), a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced initial results from a Phase I multicenter safety study of PDA-001 in treatment-resistant Crohn's Disease. PDA-001 is an immunomodulatory therapy consisting of human placenta-derived cells obtained from CCT's proprietary processes.

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In the study, twelve patients with active moderate-to-severe Crohn's Disease who were unresponsive to at least one prior therapy were given two infusions of PDA-001 one week apart. The first six patients received two infusions of 2x10⁸ cells (Low Dose) and the next six received two infusions of 8x10⁸ cells (High Dose).

The study met its primary endpoint of safety and demonstrated encouraging clinical benefit including clinical remission. Based on these results, the company has decided to further evaluate the clinical potential of PDA-001 in multiple Phase II studies across a number of disease states.

"The results of this study are an important first step in our understanding of the role PDA-001 may play in serious and debilitating diseases," said Robert Hariri, M.D., Ph.D., CEO of CCT. "We are encouraged that in these patients with Crohn's disease, our unique, placenta-derived therapies show signs of clinical benefit. We will continue to aggressively pursue the clinical development of this and other cellular therapies derived from what we see as one of the richest sources of uniquely functional and versatile cells."