Toronto, Canada, Rehovot, Israel and Bangkok, Thailand (PRWEB) July 10, 2006
TheraVitae, an international biotechnology company, the producer of VesCell™ a cellular therapy for heart disease and developer of additional adult stem cell technologies for incurable disorders completed a North American license agreement with TheraVitae Inc., which establishes TheraVitae Inc. as an exclusive licensee of North America. In parallel with the closing of the agreement, TheraVitae Inc. completed a $3,000,000 non-brokered private placement.
The license agreement provides TheraVitae Inc. with an exclusive license to all stem cell therapies and intellectual property (current and future) produced by the Licensor during the term of the agreement. The Company will start clinical development of the lead product VesCell™ and will continue to develop additional products for cardiovascular and other severe disorders. Established in Toronto, Canada TheraVitae Inc. plans to submit regulatory requests to Health Canada and the FDA for a clinical trial of its therapy for congestive heart failure.
TheraVitae is one of the world’s leading stem cell therapy companies focused on using the patient's own (autologous) adult stem cells to treat a variety of disorders, especially cardiovascular diseases. Nominated by the World Economic Forum as a Technology Pioneer for 2006, the company has conducted a clinical trial in Bangkok, Thailand that led to the approval of its first therapy, VesCell™ as a treatment for “no option” heart patients. Over 130 patients suffering from very severe angina pectoris or heart failure have been successfully treated with VesCell™ by either administration of the cells through the heart arteries, or by direct injection into the heart muscle.
On April 12, 2006, the company announced the enrolment of its first patient in a clinical trial to study the safety and efficacy of the administration of autologous adult stem cells to patients suffering from severe Peripheral Artery Disease (PAD), a deficiency of blood supply to the lower limbs.
Dr. Valentin Fulga, CEO of TheraVitae Group and Chairman and President of TheraVitae Inc. said: “We are now in a position to launch operations in North America and initiate rigorous efforts that will hopefully lead to regulatory approvals of our products in North America. We plan to work together with the most experienced physicians and surgeons in North America and to prove the safety and efficacy of our technologies We are ready to engage in intensive activities to bring our therapies to the millions of suffering patients that can potentially be helped with our treatments.”
About Heart Disease
Approximately 13 million Americans, or 7% of the population, have one or more types of heart disease, a disease which caused one of every five deaths in the US in 2003 and which is the single largest killer of Americans. An individual is more than 10 times more likely to die of heart disease than in an accident and more than 30 times as likely to die of heart disease than of AIDS. Approximately every 26 seconds an American will suffer a coronary event, and about every minute someone will die from one. The resulting costs for the treatment of heart disease in the US are enormous, estimated to reach $258.5 billion in 2006.
PAD is a form of atherosclerosis—the hardening and narrowing of the arteries, caused by the gradual buildup of fatty deposits and other substances. PAD affects 8 million to 12 million people in the US, afflicting men and women equally. By age 70, almost 20 percent of the population is affected. Estimates suggest that approximately 1% of adults over 50 years of age suffer from severe PAD, which translates to an estimated population of between 1.5–2 million patients in Europe and the US. Such patients require prompt surgical attention. Otherwise they are likely to require limb amputation. It is estimated that 150,000 amputations are carried out in the US and Europe annually after failure of such surgery.
For Additional Information on Stem Cell Therapy:
VesCell Website: http://www.vescell.com
Stem Cell Therapy Blog: http://stem-cell-therapy.blogspot.com
TheraVitae Corporate Website: http://www.theravitae.com
36/72 PS Tower, 21/Fl., Sukhumvit 21, Klongtoey Nua, Bangkok 10110
Phone: +662-664-4290/3 Fax: +662-664-42-89
7 Pinhas Sapir Street P.O. Box 4049, Ness Ziona 74140, Israel
Phone: +972-8-9409170 Fax: +972-8-9409167