Celgene Cellular Therapeutics Announces Top-Line Results from First Clinical Study with Placenta-Derived Cells (PDA-001)
Early-Stage Phase I Study Results in Treatment-Resistant Crohn's Disease
WARREN, N.J.--(BUSINESS WIRE)--Apr 8, 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.
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.”
About Crohn's Disease
Crohn's disease, a chronic inflammatory condition of the gastrointestinal tract, impacts almost one million people in the United States alone. Traditional treatment for Crohn's disease has focused on non-specific anti-inflammatory or immunosuppressive agents. A considerable proportion of patients develop clinically significant side-effects, require surgery or become unresponsive to therapy.
About Celgene Cellular Therapeutics
Celgene Cellular Therapeutics (CCT), a wholly-owned subsidiary of Celgene Corporation, discovers and develops therapeutics from cells derived from the human placenta as well as from the umbilical cord. CCT is a state-of-the-art research and development organization dedicated to fulfilling the promise of cellular therapeutics by developing cutting-edge products and therapies that will significantly benefit patients. The goal of CCT is to develop proprietary cell therapy products for the treatment of unmet medical needs. Cellular therapies offer the potential to provide disease-modifying or even curative outcomes for serious diseases, which today lack adequate therapy.
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. In a recent Nature magazine article, Celgene Cellular Therapeutics was shown to have two of the top 10 “most important patents identified as brokering knowledge in stem cell research”. PDA-001 is the first product to be developed as a result of this expanding portfolio.
About Placenta-Derived Cells
PDA-001 is a proprietary stem cell population derived from normal, full-term human placental tissue. It may have broad therapeutic potential in multiple therapeutic areas and is scalable to a traditional pharmaceutical level.
PDA-001 is a culture-expanded plastic adherent, undifferentiated in vitro cell population that expresses the nominal phenotype CD34-, CD10+, CD105+ and CD200+. PDA-001 cells constitutively express moderate levels of HLA Class I and undetectable levels of HLA Class II, and they do not express the co-stimulatory molecules CD80 and CD86. PDA-001 is genetically stable, displaying a normal diploid chromosome count, normal karyotype and exhibit normal senescence after prolonged in vitro culture.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control. The Company's actual results, performance, or achievements could be materially different from those projected by these forward-looking statements. The factors that could cause actual results, performance, or achievements to differ from the forward-looking statements are discussed in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, 10-Q and 8-K reports. Given these risks and uncertainties, you are cautioned not to place undue reliance on the forward-looking statements.
Contact: Celgene Cellular Therapeutics
Chief Executive Officer
Robert Hariri, M.D., Ph.D., 732-564-3503
Associate Director, Public Relations
Greg Geissman, 908-673-9854
Posted: April 2010