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:2/13/2016)... ... February 13, 2016 , ... Valentine’s Day is nearly upon us, ... big day. A great outfit, flawless hair, and a sparkling personality are all well ... themselves to a night at home with Rover. (Actually, man’s best friend might not ...
(Date:2/13/2016)... ... ... individuals looking to lead a healthy lifestyle have decreased carbohydrate consumption and increased their ... delved into this niche allowing those giving up their beloved pasta a chance to ... of protein and only 7 grams of carbohydrates per 50 gram serving--a ratio that ...
(Date:2/13/2016)... ... February 13, 2016 , ... The producers of Enterprises TV ... , The increasingly modern world of instantaneous consumption proves very convenient for businesses. ... such as oil and coal, which pollutes our air, water, and soil. It can ...
(Date:2/13/2016)... ... 13, 2016 , ... Christie Medical Holdings, Inc. presented the ... VeinViewer® Vision vein finder for the nursing school simulation lab. This ... draw blood, combining technology with traditional technique. , “VeinViewer is a wonderful new ...
(Date:2/13/2016)... Montreal, Canada (PRWEB) , ... February 13, 2016 , ... ... best foot forward. They’ll groom themselves to perfection, go out of their way to ... their date – just take a look at any online dating profile. , ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... SAO PAULO , Feb. 12, 2016 /PRNewswire/ ... has commenced a cash tender offer (the "Tender ... U.S.$312.6 million outstanding aggregate principal amount of its ... P5246AAF0 and ISIN Nos. US44915JAA88/ USP5246AAF05) (the "Notes"). ... also soliciting (the "Consent Solicitation") consents (the "Consents") ...
(Date:2/12/2016)... , February 12, 2016 /PRNewswire/ ... nicht anders vermerkt)   http://www.sedar.com ... http://www.telestatherapeutics.com abrufbar.    --> ... des Unternehmens http://www.telestatherapeutics.com abrufbar.    ... (TSX:TST; PNK:BNHLF) veröffentlichte heute seinen Konzernabschluss des ...
(Date:2/12/2016)... HOUSTON , Feb. 12, 2016  Memorial Hermann ... center Dwight Howard to bring a one-of-a-kind ... Hospital . Using cutting-edge technologies such as 360-degree video ... kids both virtually, then literally – giving the patients ... – and it was all caught on video ...
Breaking Medicine Technology: