Navigation Links
U.S. FDA Approves New THERAKOS(TM) CELLEX(TM) Photopheresis System
Date:3/23/2009

- Integrated System Treats Cutaneous T-cell Lymphoma -

EXTON, Pa., March 23 /PRNewswire/ -- Therakos, Inc., a pioneer in immune cell therapy, today announced the U.S. Food and Drug Administration (FDA) approval of 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 (ECP), an innovative cellular therapy, to relieve the symptoms of CTCL. The system also has been cleared recently in Canada and Europe.

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 reinfusion errors 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 blood cells from whole blood.

"Advancements in the new THERAKOS(TM) CELLEX(TM) Photopheresis System have opened up this important treatment option to patients for whom it was previously unfeasible," said Larisa J. Geskin, MD, FAAD, Director of Cutaneous Oncology and Photopheresis Unit and Dermatology Residency Program Director at the University of Pittsburgh School of Medicine. "This new system requires less extracorporeal blood volume at any one time, making it possible to treat lower weight patients and others previously not considered for this therapy." Dr. Geskin acted as a principal investigator for the CELLEX(TM) Photopheresis System and is a paid consultant for Therakos.

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. "Treatment options for patients with CTCL have been limited because it is a rare disease," said Judy Jones, the founder and President of the Cutaneous Lymphoma Foundation. "We are thrilled about the FDA's decision to approve the new THERAKOS(TM) CELLEX(TM) Photopheresis System, which will give patients suffering from painful skin lesions an important new therapeutic option." The Cutaneous Lymphoma Foundation is an independent, non-profit patient advocacy organization and provides educational programs which are partially supported by industry partners. In the past, they have received educational grants from Therakos, Inc.

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 and in January 2009 it received regulatory clearance from Health Canada.

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, 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.

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 2 to 3 percent of all cases of NHL lymphoma and mostly affects adults. In the United States, there are about 1,500 new cases of CTCL per year.

About Therakos, Inc.

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. For more information, visit www.therakos.com.


'/>"/>
SOURCE Therakos, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. FDA Approves First Anti-Psychotic for Kids
2. FDA Approves New Roche West Nile Virus Blood Screening Test
3. FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk
4. FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis
5. FDA Approves SOMA(R) (carisoprodol) 250 mg
6. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
7. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
8. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
9. ABIH Approves Certification Credit for SSPC Training Courses
10. FDA Approves REALIZE(TM) Adjustable Gastric Band for Morbid Obesity
11. FDA Approves New Flu Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... ... May 24, 2016 , ... ... of communication enabled solutions and managed services today announced a strategic partnership ... enterprise contact center market. , Altura, one of Avaya’s largest Platinum Business ...
(Date:5/24/2016)... ... May 24, 2016 , ... How to Write Error Free ... http://www.fdanews.com/humanerrordrugdevice , Human error is known to be the major cause of ... will ever be totally eliminated, many human performance problems can be prevented. , How ...
(Date:5/24/2016)... ... May 24, 2016 , ... Regenerative Medicine is being ... adult stem cell therapy technology, protocols and patient results as have been achieved with ... become a more accessible standard of care for patients worldwide. , As the Medical ...
(Date:5/24/2016)... NY (PRWEB) , ... May 24, 2016 , ... ... treatment for physical disease or injury that focuses on repairing the musculoskeletal and ... , With an emphasis on functional restoration, NYDNRehab began providing treatments for physical ...
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... A newly ... rely heavily on their access to trusted resources, both in face-to-face interactions and online. ... Men of Color,” researchers concluded that the creative use of mobile digital devices can ...
Breaking Medicine News(10 mins):
(Date:5/23/2016)... 23, 2016 Global Paclitaxel Market ... profiles 12 companies and the Paclitaxel analysis in this ... the industry and its players. This is ... nature, details the current state of the industry while ... classifications, applications and industry chain structure. The Paclitaxel market ...
(Date:5/23/2016)... 2016 Clarifying Vision - Prospects ... and Vision Care What can be expected ... to grow at the fastest rates? This visiongain ... data, trends, opportunities and prospects. ,Our ... the most lucrative areas in the industry and the ...
(Date:5/23/2016)... 2016 Gamida Cell, a leader ... cancer and orphan genetic diseases, announced today it has ... from the Israel Innovation Authority (formerly the Office of ... and Industry. The mission of the Israel Innovation Authority ... including science and technology, while stimulating economic growth. ...
Breaking Medicine Technology: