Exton, PA (January 28, 2009) - Therakos, Inc., a pioneer in photopheresis therapy for more than 20 years, today announced that Health Canada has cleared the THERAKOS™CELLEX™Photopheresis System for the palliative (reducing the severity of symptoms) treatment of the skin manifestations (appearance) of cutaneous T-cell lymphoma (CTCL) that are unresponsive to other forms of treatment. The THERAKOSTM CELLEXTM Photopheresis System is an easy-to-use, integrated system that uses extracorporeal (outside the body) photopheresis, an innovative cellular therapy, to relieve the symptoms of CTCL.
CTCL is a type of non-Hodgkin lymphoma, a condition in which lymphocytes, a type of white blood cell, become cancerous and affect the skin. According to Dr. John Klassen, Director of the Apheresis Program for Southern Alberta at Foothills Medical Centre, "The skin lesions associated with CTCL can cause painful breaks in the skin that do not heal and can become infected. These patients can also suffer from severe and untreatable itching. I have had success in treating these difficult cases with extracorporeal photopheresis."
The new THERAKOS™CELLEX™Photopheresis System features several improvements designed to enhance the patient treatment experience, such as shorter treatment times and reduced extracorporeal blood volume. The benefits of reduced risk of infection and cross-contamination are maintained in the THERAKOS™CELLEX™Photopheresis System from the current THERAKOS™UVAR™XTS™Photopheresis System. Specific features of the new system include an automated, closed system design that provides users the ability to switch between double and single needle treatment, if necessary. The system also utilizes a new, patented separation technology to separate white cells from whole blood.
Therakos, Inc. currently markets the world's only approved integrated systems for extracorporeal photopheresis. "The new features of the THERAKOS™CELLEX™Photopheresis System were designed specifically to create a better treatment experience for both patients and the health care professionals administering the therapy," stated Michael Yang, General Manager of Therakos, Inc. "This new system is an example of a medical device and a drug therapy combining in a unique and innovative way to deliver favorable outcomes for patients."
In April 2008, the THERAKOS™CELLEX™Photopheresis System received a CE Mark for use in Europe to perform extracorporeal photopheresis. For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at: www.therakos.com.
About Extracorporeal Photopheresis (ECP)
ECP is a therapeutic procedure performed outside the body using the THERAKOS™CELLEX™Photopheresis System 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, a drug used to treat some cutaneous lymphomas and skin disorders in conjunction with exposure to ultraviolet 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 cells1.
About Cutaneous T-cell Lymphoma (CTCL)
CTCL is a type of non-Hodgkin lymphoma, 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. The Cutaneous Lymphoma Foundation estimates there are approximately 3,000 cases across Canada. According to the Lymphoma Research Foundation, CTCL accounts for two to three percent of all cases of non-Hodgkin lymphoma in the United States.
Therakos, Inc., a Johnson & Johnson company, has been a pioneer for more than 20 years in immune cell therapies. Therakos, Inc. markets the only approved integrated systems for extracorporeal photopheresis.
1Reference: Maeda A, Schwarz, A, Kemebeck, K, et al. Intravenous infusion of syngeneic apoptotic cells by photopheresis induces antigen-specific regulatory t-cells. J. Immunol. 2005;174:5968-5976.
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