Health Canada Clears New THERAKOS(TM) CELLEX(TM) Photopheresis System



    - Integrated System Treats Cutaneous T-cell Lymphoma -

    EXTON, PA, Jan. 28 /CNW/ - Therakos, Inc., a pioneer in photopheresis
therapy for more than 20 years, today announced that Health Canada has cleared
the THERAKOS(TM) CELLEX(TM) 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(TM) CELLEX(TM) 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(TM) CELLEX(TM) 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(TM) CELLEX(TM) Photopheresis System from the current THERAKOS(TM)
UVAR(TM) XTS(TM) 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(TM) CELLEX(TM) 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(TM) CELLEX(TM) 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(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
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 cells(1).

    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.

    About THERAKOS

    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.

    
    (1)Reference: 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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For further information: Media Contact: Stephanie Fagan, (908) 704-3691,
Mobile: (201) 572-9581

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