Theravitae Initiates First Cell Therapy Clinical Trial In South East Asia For Myocardial Ischemia

Published: Aug 17, 2004

Bangkok, Thailand, August 17, 2004 - Theravitae, a biotechnology company specialized in cellular therapy, enrolled the first patient in its clinical trial to study the safety and efficacy of the administration of endothelial progenitor cells to patients with severe angina pectoris. The study, conducted at Siriraj Hospital, the largest hospital in Bangkok, Thailand, will assess the treatment in twenty four patients with severe chronic angina who meet certain inclusion and exclusion criteria.

Endothelial progenitor cells, EPCs, are stem cells harvested from the patient's own blood that have the capability to form new blood vessels, or angiogenesis. EPCs are found in the blood stream, but in a very low concentration. Theravitae has developed proprietary technologies to harvest, expand and differentiate EPCs to an amount sufficient to induce angiogenesis in the heart. The cells are processed outside the body and then injected into the patient during standard angiography to regions of the heart suffering from reduced blood supply. Injection of EPCs in cardiac patients has proven to increase blood supply to the heart muscle and reduce symptoms of angina in several trials in the USA and Europe. "We are very excited to start this collaboration with our Thai colleagues. It is one of the first clinical trials of cell therapy undertaken in Thailand and we are glad that Theravitae is the company to sponsor it. Our initial conviction of the top quality of medical practice in Thailand was reinforced during the last six months of intensive work with the Thai cardiologists. We were impressed by the level of experience and professionalism and look forward to continuing this collaboration further", said Dr. Valentin Fulga, chief executive officer of Theravitae.

The potential success of this trial would mean that heart patients would now have another treatment option other than coronary bypass surgery. Furthermore, treating these patients with cell therapy is potentially safer for the procedure is similar to a cardiac catheterization which is routinely performed to examine a patient's heart function and blood supply. Moreover, employing autologous EPCs (cells taken from the patient himself/herself) eliminates concerns of tissue rejection.

Associate Professor Damras Tresukosol, MD, Head of the Invasive Unit, Director of Catheterization Laboratory of Her Majesty Cardiac Center, Faculty of Medicine, Siriraj Hospital, Thailand, the principal investigator in the study commented, "This trial will determine the efficacy and safety of a new heart treatment option for Thais who have severe anginal symptoms despite undergoing another revascularization therapy. This new approach might tremendously change our perspective to heart problems, quality of life and even life expectancy."

Professor Suphachai Chaithiraphan, MD, President of the Heart Association of Thailand and President of the Thai Atherosclerosis Society, said "During the past decade, I was always intrigued by the idea of cell therapy to the heart and kept myself updated ever since. Now it is close to becoming a reality."

Theravitae is committed to developing new therapeutic strategies for patients with life-threatening diseases. Clinical operations are coordinated from the Bangkok Headquarters. Research, development and manufacturing are performed at the company's state of the art cell therapy facility located in Kiryat Weizmann, Israel. Theravitae's current pipeline is focused on cardiac disorders, with treatments for optical and neurological diseases emerging in the future.

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