Navigation Links
First Patient Enrolled in Therakos Phase Two Study for Treatment of Graft-versus-Host Disease
Date:12/6/2011

RARITAN, N.J., Dec. 6, 2011 /PRNewswire/ -- Therakos, Inc., a pioneer in the innovative treatment of extracorporeal photopheresis (ECP) for immune modulation therapy, today announced that the first patient has been enrolled in its Phase IIb clinical study evaluating the use of the company's photopheresis technology in the treatment of patients with moderate-to-severe chronic Graft-versus-Host Disease (GvHD). An estimated 15,000 new patients worldwide are diagnosed every year with chronic GvHD, a life threatening condition occurring when a donor's transplanted stem cells attack the recipient's body.(1)(2)

"In the United States, there is a significant need for improved Graft-versus-Host Disease treatments as current therapies aim to suppress the immune system and can be extremely harsh on an already compromised patient," said Dennis Parenti, M.D., Vice President of Clinical Affairs, Therakos. "We are very excited about this investigation of photopheresis for chronic GvHD patients."

The Therakos study will assess the safety and efficacy of ECP treatment as an add-on to the standard of care for patients suffering from moderate-to-severe GvHD. ECP is a therapeutic procedure performed outside the body using either the THERAKOS™ UVAR™ XTS™ Photopheresis System or the THERAKOS™ CELLEX™ Photopheresis System. Patients will be enrolled over an 18-month period. Randomization will occur in a 1:1 ratio with half of the patients receiving the current standard of care and the other half receiving standard of care coupled with ECP.

The initial patient was enrolled by Vikas Bhushan, M.D. at The Medical City Dallas Hospital in Texas who is serving as an investigator in the trial. Dr. Bhushan commented, "I am pleased to be a part of this unique prospective comparative study rigorously evaluating photopheresis in chronic Graft-versus-Host Disease. ECP has been utilized to treat many immune-based diseases and I look forward to assessing the clinical outcomes of this therapy for patients in the study," he added.

The clinical study will consist of patients from across the United States and Europe. There will be roughly 35 sites participating in the clinical trial. Full results of the study are expected in early 2013 and will form the basis for a global Phase 3 study.

About Extracorporeal Photopheresis (ECP)

ECP is a therapeutic procedure performed outside the body using either the THERAKOS™ UVAR™ XTS™ Photopheresis System or the THERAKOS™CELLEX™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.

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.(2) In the United States, there are about 1,500 new cases of CTCL per year.(3)

About Therakos, Inc.

Therakos, Inc. is a leader in advancing the science of immune cell therapies harnessing a combination of expertise in medical devices and pharmaceuticals. Therakos markets the world's only approved integrated systems for extracorporeal photopheresis (ECP). For 25 years, physicians have been using THERAKOS™ Photopheresis Systems to treat their patients, with more than 600,000 treatments administered worldwide. For more information, visit www.therakos.com.

 

(1)   Greinix HT; Graft versus Host Disease UniMed Verlag AG
(2)   http://www.rightdiagnosis.com/g/graft_versus_host_disease/prevalence.htm, Sept 28, 2011.
(3)   http://www.lymphoma.org  
(4)   http://www.clfoundation.org

 


'/>"/>
SOURCE Therakos, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Heart Hospital of Austin Physician First in Texas to Implant New Heart Failure Device
2. Mylan Receives Tentative FDA Approval Through PEPFAR for First Heat-Stable, Fixed-Dose Combination of Atazanavir Sulfate and Ritonavir Tablets for HIV/AIDS
3. Arbor Pharmaceuticals Announces Filing of First NDA
4. Mylan Confirms First-to-File Patent Challenge Relating to Generess™ Fe
5. Auxilium Pharmaceuticals, Inc. Announces First Patient Dosed in XIAFLEX® Study for Frozen Shoulder Syndrome
6. FDA Approves First Generic Version of Cholesterol-Lowering Drug Lipitor
7. Philips MicroDose Next Generation Mammography Solution Gains Traction with First North American Customers, Enabling Excellent Image Quality at a Low Radiation Dose
8. Uptake Medical Announces First Commercial Use of InterVapor for Patients With Severe Emphysema
9. Odyssey Thera is First to Install Next Generation High-Content Imaging Capability
10. China Cord Blood Corporation Reports Financial Results for the Second Quarter and First Half of Fiscal 2012
11. Samplify Systems Announces Availability of First Ultrasound Beamforming ASIC For Merchant Market
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... Research and Markets has announced the addition ... Industry Forecast to 2025" report to their offering. ... The Global Wireless Health ... over the next decade to reach approximately $330.5 billion by 2025. ... for all the given segments on global as well as regional ...
(Date:2/24/2017)... 2017 Research and Markets has announced the addition ... report to their offering. ... The latest research Dry eye Drugs Price Analysis and Strategies - ... market. The research answers the following questions: ... clinical attributes? How are they positioned in the Global Dry eye market? ...
(Date:2/24/2017)... Juan Monteverde , founder and managing ... boutique securities firm headquartered at the Empire State Building ... that a class action lawsuit has been filed in the ... Inotek Pharmaceuticals Corporation (NASDAQ:  ITEK)("Inotek" or the "Company") on ... 2015 and December 30, 2016, inclusive (the "Class Period").  ...
Breaking Medicine Technology:
(Date:2/26/2017)... San Mateo, CA (PRWEB) , ... February 26, 2017 , ... ... Bay Area cities as diverse as Millbrae, Belmont, and Palo Alto, is proud to ... San Mateo. Many Bay Area consumers look for home care close to home, and ...
(Date:2/26/2017)... ... February 26, 2017 , ... ... in staffing, scheduling, and reporting for healthcare organizations. This comprehensive and customizable ... entire staffing process. StaffBridge technology improves staffing efficiency, maximizes resource allocation, collects ...
(Date:2/26/2017)... Florida (PRWEB) , ... February 26, 2017 , ... ... of Parkinson’s disease (PD) in persons with a specific LRRK2 mutation, according to ... Congress. , Previous studies have provided evidence of a link between pesticides and ...
(Date:2/24/2017)... , ... February 24, 2017 , ... ... on tooth replacement options at his office, Antoine Dental Center. Currently, patients can ... $18,499. Some restrictions may apply, but patients can learn more about these offers ...
(Date:2/24/2017)... ... February 24, 2017 , ... An in-depth computational analysis of genetic variants ... points to eight genes that may explain why susceptibility to one of the disorders ... a study published today in the journal npj Schizophrenia. , “There is a ...
Breaking Medicine News(10 mins):