First Patient Enrolled in Therakos Phase Two Study for Treatment of Graft-versus-Host Disease

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.(3) In the United States, there are about 1,500 new cases of CTCL per year.(4)

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.