Health Canada Clears New Therakos™ Cellex™ Photopheresis System

Integrated System Treats Cutaneous T-cell Lymphoma

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 THERAKOS™ CELLEX™ 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.