New Study Demonstrates Effectiveness of Extracorporeal Photopheresis in Early-Stage Cutaneous T-Cell Lymphoma

Data published in CLINICAL LYMPHOMA, MYELOMA & LEUKEMIA supports safe, effective use of ECP therapy for patients exhibiting mycosis fungoides

Raritan, NJ, (August 29, 2011) – Therakos, Inc., a pioneer in immune cell therapy, today announced that a study published in Clinical Lymphoma, Myeloma & Leukemia demonstrates extracorporeal photopheresis (ECP) is safe and effective in early-stage mycosis fungoides (MF). MF is the most common form of cutaneous t-cell lymphoma (CTCL) affecting approximately 16-20,000 persons in the U.S. 2

The study titled, “Multicenter Photopheresis Intervention Trial in Early Stage Mycosis,” show that ECP provided benefit to patients with early stage MF with low toxicity and improved quality of life. Specifically, the data demonstrated that 42 percent of patients responded to ECP monotherapy, and when additional therapy was added at month three, an overall response of 63 percent resulted. Patients showed improvement in quality of life as evidenced by improvement in all three scales of the Skindex-29 19, as well as most components of the SF-36 version 2.0.

“This study provides important evidence, reinforcing the safe and effective use of ECP in early stage cutaneous T-cell lymphoma (CTCL) patients to help relieve pain and symptoms associated with this debilitating disease,” said Madeleine Duvic, M.D.,

Deputy Chairman, Department of Dermatology, The University of Texas MD Anderson Cancer Center. “While additional studies are required to confirm findings, the data suggest a response rate in early stage MF similar to that seen in advanced CTCL, suggesting that blood involvement, which is typical of advanced disease, may not be required for patients to respond to ECP alone.”

The purpose of the open label, single arm study was to evaluate the efficacy of ECP in patients with early-stage MF (stage IA-IIA) with limited skin disease, as well as assess health-related quality of life. ECP was conducted with the THERAKOS™ UVAR XTS™ Photopheresis System for two consecutive day treatments every four weeks for six months. After three months of ECP, patients without partial response or with stable progressive disease in skin could add oral bexarotene alone or combined with alpha interferon. Health-related quality of life was assessed at baseline and every three months with three validated tools (Skindex 29, SF-36v2 and FACT-G). Results showed that ECP was well tolerated with treatment-related side effects limited to those expected with other treatment agents used in the study.

Mycosis fungoides is a type of non-Hodgkin’s lymphoma that generally affects the skin but may progress over time to involve the lymph nodes and internal organs1. Although rare, MF is the most common type of CTCL, with approximately 1,000 patients diagnosed in the U.S. every year3. Depending on the severity of the disease, symptoms of CTCL-MF include patches, plaques and tumors that range from red, itchy skin to severe lesions and bumps. These symptoms are similar to other skin conditions, which make it difficult to diagnose in early stages1. In late stage CTCL-MF patients, where the disease has spread to the blood, extracorporeal photopheresis (ECP) has been widely used to control skin symptoms.

About THERAKOS™ Photopheresis Systems

ECP is a therapeutic procedure performed outside the body using the THERAKOS™ Photopheresis Systems to withdraw a volume of whole blood that is then centrifuged to separate the white blood cells from the red blood cells and plasma. The red blood cells and plasma are immediately returned to the patient. The white blood cells are treated with methoxsalen, which is photoactivated after exposure to UVA light. The treated white blood cells are then reinfused into the patient. Clinical studies suggest that the treated white blood cells, when reinfused into the body, may bring the immune system into balance by controlling the activity of overactive immune cells.

Currently, the THERAKOS™ Photopheresis Systems are approved in the United States for the palliative treatment of the skin manifestations of CTCL that are unresponsive to other therapies.

About Cutaneous T-cell Lymphoma (CTCL)

CTCL is a type of non-Hodgkin lymphoma (NHL), a condition in which lymphocytes, a type of white blood cell, become cancerous and affect the skin. Patients may experience symptoms of thickened, red, cracking, scaling or intensely itchy skin in localized areas or all over the body. Some patients experience blood, lymph node and/or internal organ involvement with serious complications. Many patients live normal lives during treatment and some are able to remain in remission for long periods of time. According to the Lymphoma Research Foundation, CTCL accounts for about 10 to 15 percent of all cases of NHL lymphoma and mostly affects adults3. In the United States, there are about 1,500 new cases of CTCL per year2.

About Therakos, Inc.

Therakos, Inc., part of the Johnson & Johnson family of companies, is a leader in advancing the science of immune cell therapies, harnessing a combination of expertise in medical devices and pharmaceuticals. Therakos markets the world’s only approved integrated systems for extracorporeal photopheresis (ECP). For 25 years, physicians have been using THERAKOS™ Photopheresis Systems to treat their patients, with more than 600,000 treatments administered worldwide. For more information, visit www.therakos.com.

MEDIA CONTACT:

Michelle Bauman

(908) 218-8494

mbauman@its.jnj.com

Posted: August 2011

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