Therakos commences enrollment in photopheresis Phase IIb clinical study for chronic GvHD

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.

"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.