ECP May Be Effective In Treating Crohn's Disease

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ECP May Be Effective In Treating Crohn's Disease

30 May 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 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.

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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 tooik 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 & 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.

Contact: Mount Sinai Press Office

The Mount Sinai Hospital / Mount Sinai School of Medicine

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