Celgene Cellular Therapeutics Receives FDA Clearance for First …

Celgene Cellular Therapeutics Receives FDA Clearance for First Placenta-Derived Stem Cell Clinical Study

-- Trial is First Application of Company's Proprietary Cell Therapy Product--

WARREN, N.J.--(BUSINESS WIRE)--Celgene Cellular Therapeutics (CCT), a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced the U.S. Food and Drug Administration (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 CCT's proprietary processes. Clinical development will begin by the end of the year with the initiation of this Phase I, multi-center clinical trial in the U.S. for patients with moderate-to-severe Crohn's disease, who are refractory to oral corticosteroids, such as prednisone, and immune suppressants.

PDA001 is a novel culture expanded stem cell population that has broad therapeutic potential in areas such as immunology, inflammation, hematology and oncology. Pre-clinical evaluation of PDA001 has demonstrated its safety and potent immune-suppressive properties. A placenta-derived stem cell therapy, PDA001 has several potential significant benefits in that the cells are derived from a safe and almost unlimited source and are scalable to a traditional pharmaceutical level.

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 the first product to be developed as a result of this expanding portfolio.

"This first placental-derived stem cell clinical trial is of vital importance given the significant number of people suffering from this debilitating disease," said lead investigator Dr. Lloyd F. Mayer, Professor and Director of the Immunology Institute, Professor of Medicine and Chief of the Divisions of Clinical Immunology and Gastroenterology at Mount Sinai in New York City. "With the positive results from in vivo biodistribution and safety studies, our hope is that PDA001 will suppress the atypical immune and inflammatory reactions involved in the pathogenesis of Crohn's disease, thereby resulting in a decrease in symptoms and improved quality of life for patients."

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. Unfortunately, a considerable proportion of patients develops intolerable side-effects, requires surgery or becomes unresponsive to therapy.

"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," said Robert Hariri, M.D., Ph.D., CEO of Celgene Cellular Therapeutics. "By creating a novel cell therapy from a readily available source that does not require human leukocyte antigen-matching, we are hopeful that we can treat a large number of patients with a variety of devastating diseases."

About Celgene Cellular Therapeutics

At Celgene Cellular Therapeutics (CCT) we discover and develop therapeutics from stem 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. Our goal is to develop proprietary cell therapy products for the treatment of unmet medical needs. Stem cell based therapies offer the potential to provide disease-modifying or even curative outcomes for serious diseases, which today lack adequate therapy.

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Celgene Cellular Therapeutics Receives FDA Clearance for First ...