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Most End-Stage Heart Disease Patients Show Significant Improvement After Adult Stem Cell Treatment; Interim Clinical Data From TheraVitae Study Presented At AHA Scientific Sessions

Posted on: Wednesday, 16 November 2005, 12:00 CST

TheraVitae, an international biotechnology company and the producer of VesCell(TM) adult stem cell therapy for heart disease, today presented interim clinical data showing significant improvement in patients suffering from severe angina pectoris six months after they received the company's autologous adult stem cell therapy.

Unlike most clinical trials currently underway, VesCell uses adult stem cells derived from a patient's own blood rather than his or her bone marrow.

Prof. Alex Battler, MD, Director of Cardiology at the Rabin Medical Center in Israel and TheraVitae's chief medical officer, presented the results at the American Heart Association's Scientific Session here. In addition to showing that VesCell has a high safety profile the results demonstrate that:

-- 93% of patients reported an increased ability to perform

physical exercise.

-- 62% showed improvement in treadmill exercise capacity.

-- 73% of patients showed an improvement in perfusion defect of

the ischemic region, assessed by SPECT.

The study, evaluating the safety and efficacy of intracoronary administration of VesCell to patients suffering from severe angina pectoris, is being conducted in conjunction with Her Majesty's Cardiac Center at Siriraj Medical Hospital in Bangkok, Thailand.

VesCell technology facilitates the isolation, expansion and differentiation of angiogenic cell precursors (ACPs) to an amount sufficient to induce blood vessel formation in the heart. Cells are isolated from the blood, processed outside the body and then administered to the patient during standard catheterization to regions of the heart suffering from reduced blood supply.

According to Dr. Battler, "The results are a major step toward proving the safety and efficacy of VesCell therapy, and demonstrating the reliability of TheraVitae's cell manufacturing process. Moreover, they illustrate the considerable benefits and low risk that VesCell therapy provides to patients."

David Czeiger, MD, medical director at TheraVitae said, "These results are extremely encouraging and reaffirm our belief that VesCell can make a substantial, positive difference in the lives of patients suffering from severe angina pectoris." Dr. Czeiger added, "I'd like to give special thanks to Damras Tresukosol, MD, of Siriraj Hospital, who is the chief investigator of the trial. Without his tireless efforts, this study would not have been possible."

"The results seen so far support our view that autologous Angiogenic Cell Precursors (ACP) therapy might someday significantly alter currently accepted treatment strategies towards heart problems," said Prof. Suphachai Chaithiraphan, MD, president of the Heart Association of Thailand and President of the Thai Atherosclerosis Society. "The benefit to patients' quality of life is a particularly positive aspect of the results we have seen and has convinced us to start treating patients with no other therapeutic options outside of the clinical trial. Thus, several dozen patients with severe angina and/or heart failure have already been treated off trial in Thailand."

Valentin Fulga, MD, CEO of TheraVitae, added: "Working on this landmark study with our Thai colleagues has been both exciting and fruitful. By presenting these encouraging results together at the American Heart Association meeting, we hope to have expanded the medical community's knowledge about the utilization of novel stem cell therapies. TheraVitae strives to be at the forefront of both scientific and medical technology and to offer hope to patients suffering from hitherto untreatable diseases."

Dr. Fulga went on to say, "More and more patients worldwide are contacting us and requesting treatment. We are helping many of them, provided of course, that the cardiologists find them eligible for treatment. In the future, TheraVitae will expand its therapy portfolio to include additional diseases that are presently considered to be incurable."

VesCell(TM) -- A Natural Treatment for Heart Disease

The body has natural ways of healing itself and the cardiovascular system is no exception. Angiogenic Cell Precursors (ACPs) originate in bone marrow and then circulate in the blood vessels. To manufacture VesCell(TM), TheraVitae expands a small number of ACPs harvested from about 250cc of blood into a therapeutic quantity. VesCell is injected either through a coronary artery via catheter, or during thoracoscopic surgery, directly into the heart muscle. A key aspect of VesCell(TM) therapy is the advanced cell isolation and expansion technique that allows for the ACPs to be harvested from blood collected in a procedure similar to a common blood donation. VesCell(TM) uses a patient's own adult stem cells to treat Heart Disease and is a viable therapeutic possibility for heart patients without any other treatment option.

Additional Information on Cell Therapy:

VesCell Web Site: http://www.VesCell.com

Stem Cell Therapy Blog: http://www.stem-cell-therapy.vescell.com

TheraVitae Corporate Web Site: http://www.theravitae.com

TheraVitae Thailand 36/72 PS Tower, 21/Fl., Sukhumvit 21, Klongtoey Nua, Bangkok 10110 Phone: 02-664-4290/3 Fax: 02-664-42-89 Theravitae Israel 7 Pinhas Sapir Street P.O. Box 4049, Ness Ziona 74140, Israel Phone: +972-8-9409170 Fax: +972-8-9409167

Editor's Note

High-resolution visual of 29-year-old mother beneficiary of treatment available

Source: Business Wire

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