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Therakos, Inc. Receives CE Mark in Europe For Next-Generation Photopheresis System



4/14/2008 7:03:48 AM

ASCOT, England, April 14 /PRNewswire/ -- Therakos, Inc., a pioneer for more than 20 years in immune cell therapy, announced receipt of a CE Mark in Europe for THERAKOS(TM) CELLEX(TM) Photopheresis System, a therapy for the treatment of patients with immune-mediated diseases such as acute or chronic graft-versus-host disease (GvHD) and cutaneous T-cell lymphoma (CTCL). THERAKOS(TM) CELLEX(TM) Photopheresis System is the next generation in a product line that offers the only validated, automated and integrated systems that are CE Marked to perform extracorporeal photopheresis (ECP).

The new THERAKOS(TM) CELLEX(TM) Photopheresis System offers state-of-the art technology in a single, integrated, closed system device that allows a sole operator to customize a patient's treatment and immediately adjust parameters to respond to changes in the patient's condition. A closed system offers the benefits of reduced risks for infection and infusion errors. The THERAKOS(TM) CELLEX(TM) Photopheresis System offers new features that include optimal fluid and blood volume management, user-friendly operator interface and automation with the option for simple manual intervention when needed. These features represent sophisticated treatment options that can offer the benefit of shorter overall treatment time and require lower extra corporeal volume, both important factors for patients and health care professionals.

The European Organization for Research and Treatment of Cancer (EORTC) recommends ECP among the potential therapies to be considered for the treatment of CTCL, a slowly progressive form of cancer.

About Extracorporeal Photopheresis (ECP)

ECP is a therapeutic procedure performed outside the body using the THERAKOS(TM) CELLEX(TM) 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 reinfused into 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 cells.

About Graft-Versus-Host Disease (GvHD) and Cutaneous T-Cell Lymphoma (CTCL)

Graft-versus-host disease (GvHD) occurs in allogeneic bone marrow transplants, which involve transplanted cells from a donor other than the patient. It is a life-threatening complication in which the new donor cells attack the patient's organs and tissues. The result is an inflammatory reaction targeted against the skin, mouth, lungs and liver that results in severe tight skin, mouth ulcers, difficulty breathing, liver failure and in severe cases, death. Acute GvHD starts within the first 3 months after transplant. Chronic GvHD starts more than three months after transplant, and can last for as long as three years. According to the International Center for Blood and Marrow Transplant Research, of the 14,000 allogeneic transplants performed worldwide, approximately 50 percent of patients will develop acute GvHD, and another 50 percent to 70 percent will develop chronic GvHD.

Cutaneous T-cell lymphoma (CTCL) is a slowly progressive form of cancer that has been increasing in incidence. Patients may experience symptoms of thickened, red, cracking, scaling or intensely itchy skin in localized areas or all over the body. About 10 percent of patients will have 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. There is a greater frequency among men than women and CTCL is more common after the age of 50.

For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at: http://www.therakos.com

About THERAKOS (TM)

Therakos, Inc., focuses on immune cell therapies. Based in Ascot in the United Kingdom and in Exton, Pennsylvania, in the United States, THERAKOS(TM) markets the only approved integrated systems for extracorporeal photopheresis.

Source: Therakos, Inc


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