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FDA Grants Clearance for the First Clinical Study With Placental Stem Cells

The Wall Street Journal, November 10, 2008

Celgene Cellular Therapeutics (CCT), a wholly owned subsidiary of Celgene Corporation, announced today that the U.S. Food and Drug Administration (FDA) has approved the company's investigational new drug application to initiate a clinical trial which will test PDA001, an immunomodulatory therapeutic agent that utilizes adult stem cells derived from human placental blood via a proprietary process. Phase I of the clinical process will begin in the U.S. by the end of 2008, in which a multi-center trial will test the therapy on patients with moderate-to-severe Crohn's disease who have also been found to be refractory to oral corticosteroids such as prednisone and to the immune suppressants that are commonly prescribed for such conditions.

PDA001 is a proprietary placental-derived adult stem cell therapy which is scalable to traditional pharmaceutical levels and which has applications that include immunology, inflammation, hematology and oncology. CCT owns and has patented a variety of proprietary technologies that are directed to novel placental cell types and cell populations, including 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 CCT's expanding portfolio.

According to Dr. Lloyd F. Mayer, director of the Immunology Institute, professor of medicine and chief of the divisions of clinical immunology and gastroenterology at Mt. Sinai Hospital in New York City, "This first placental-derived stem cell clinical trial is of vital importance given the significant number of people suffering from this debilitating disease. 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."

Currently nearly a million people in the U.S. alone suffer from Crohn's disease, which is a chronic inflammatory condition of the gastrointestinal tract that can be fatal in extreme cases. In the past, conventional medical treatment has consisted of non-specific anti-inflammatory or immunosuppressive agents, none of which are reliably effective and most of which cause side effects which are intolerable in a high percentage of the patients.

According to Robert Hariri, M.D., Ph.D., who is also CEO of Celgene Cellular Therapeutics, "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. 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."

Celgene Cellular Therapeutics (CCT) is an adult stem cell company the focus of which is the discovery and development of novel therapeutics based upon adult stem cells derived from human placental and umbilical cord blood. In particular, the human placenta-derived cell therapy known as PDA001 is a cellular immune modulatory agent comprised of a novel cell population that is expanded in culture after being derived from normal, healthy, full-term human placental tissue. PDA001 is known to be genetically stable, displaying a normal diploid chromosome count, normal karyotype and normal senescence after prolonged in vitro culture exposure. Additionally, PDA001 is capable of immunomodulation and has been found to suppress T-cell proliferation while exhibiting immunomodulatory effects on other cell types that are involved in the immune response such as T-cell subsets, macrophages and dendritic cells.

As the first ever to be conducted with placental-derived stem cells, these clinical trials not only represent a milestone in the treatment of Chron's disease, but also in the therapeutic advancement and availability of this particularly versatile population of adult stem cells.



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