(Washington, DC - May 23, 2007) -- Results from an international multi-center Phase II clinical trial suggest that extracorporeal photopheresis (ECP) may be effective in treating patients with clinically active (OR symptomatic) Crohn's disease who cannot tolerate or are refractory to immunosuppressants and/or anti-TNF agents. A 50% response rate after 3 months of ECP treatment was noted in the study, using standard disease activity criteria, as presented this afternoon at a scientific research session of Digestive Disease Week (DDW). The majority of patients who responded to ECP therapy had a notable improvement in their disease symptoms and signs after only six weeks of treatment.
"We show in this pilot study that ECP is effective in patients with Crohn's disease (CD) that have previously failed the strongest therapies we currently have," explains Maria Abreu, MD, Associate Professor in The Henry D. Janowitz Division of Gastroenterology and in the Center for Immunobiology at The Mount Sinai Medical Center. ECP is believed to bolster tolerance in the immune system, which may be important in immune-mediated diseases such as Crohn's. In contrast, most patients with inflammatory bowel disease are currently treated with medicines that suppress the immune system. Unlike ECP, those medications can have many serious side effects.
The 28 patient trial studied the safety and efficacy of ECP in patients with a Crohn's Disease Activity Index (CDAI) of at least 220 and less than 450 indicating that at least moderately active symptomatic CD was present. Clinical response was defined as a CDAI decrease of 100 or greater from baseline and/or a CDAI of less than 150 at week 12. Patients received two treatments of ECP weekly from weeks 0-4 and two treatments every other week from weeks 6-12 with no infectious complications reported.
"The findings of our study suggest that Crohn's disease patients who have not responded to other therapies may benefit from ECP," concludes Dr. Abreu.
About Extracorporeal Photopheresis (ECP)
During ECP treatment, a small portion of the patient's white blood cells are collected and treated with 8-methoxypsoralen, a drug that belongs to a class of naturally occurring compounds known as psoralens. Once activated by exposure to UVA (ultraviolet-A) light, the activated 8-methoxypsoralen induces apoptosis, or programmed cell death, in the white blood cells, which are then promptly returned to the patient. In this way the patient is only exposed to minute amounts of drug. ECP is usually performed on an outpatient basis over several treatment visits.
The Therakos UVAR®"XTS™ instrument, in conjunction with 8-methoxypsoralen, is the only ECP system approved by the Food and Drug Administration for the palliative treatment of the skin manifestations of Cutaneous T-cell Lymphoma that is unresponsive to other forms of treatment. The UVAR®"XTS™ is also the only device in Europe that is CE marked for ECP.
ECP as performed on UVAR®" systems has an established safety profile and more than 500,000 treatments have been conducted since 1987. The most common side effects are transient non-serious hypotensive episodes and mild transient decreases in hematocrit and hemoglobin.
About Mount Sinai School of Medicine
Located in Manhattan, Mount Sinai School of Medicine is internationally recognized for groundbreaking clinical and basic-science research, and innovative approaches to medical education. Through the Mount Sinai Graduate School of Biological Sciences, Mount Sinai trains biomedical researchers with an emphasis on the rapid translation of discoveries of basic research into new techniques for fighting disease. One indication of Mount Sinai's leadership in scientific investigation is its receipt during fiscal year 2005 of $174.1 million in research support from NIH. Mount Sinai School of Medicine also is known for unique educational programs such as the Humanities in Medicine program, which creates opportunities for liberal arts students to pursue medical school, and instructional innovations like The Morchand Center, the nation's largest program teaching students and physicians with "standardized patients" to become not only highly skilled, but compassionate caregivers. Long dedicated to improving its community, the School extends its boundaries to work with East Harlem and surrounding communities to provide access to health care and educational programs to at risk populations.
About Digestive Disease Week
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 19-24, 2007 in Washington, DC. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.
About Therakos, Inc.
Therakos, Inc., a Johnson & Johnson company, focuses on immune cell therapies and is based in Exton, Pennsylvania in the United States and Ascot in the United Kingdom. Therakos developed ECP over 20 years ago and currently markets the UVAR®"XTS™, world's only approved integrated system for Extracorporeal Photopheresis.
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