PHILADELPHIA - Temple University Hospital's Center for Vascular Disease has initiated Phase I clinical trials to test in humans a new gene therapy that may have the potential to help the body grow new blood vessels to create a bypass around blocked leg arteries.
Temple is participating in the trial to determine the safety and tolerability of the therapy to treat patients with severe peripheral arterial occlusive disease (PAOD), or critical limb ischemia. The therapy encodes the FGF1 gene, an angiogenic growth factor. The study is sponsored by RPR Gencell, the gene therapy division of Rhône-Poulenc Rorer.
"The growth factor gene, which will be injected into the leg muscles of study participants, will be studied to document its safety and, secondarily, its ability to cause the formation of new blood vessels in limbs with blocked arteries," says Dr. Anthony J. Comerota, section chief of vascular surgery at Temple, director of the Center for Vascular Disease and lead investigator of the study.
According to Comerota, if new vessels are formed, they may create a natural bypass around blocked arteries in patients who have no other alternative for restoring circulation to their leg, and are facing a high risk for amputation. Investigators hope that the additional blood flow will reduce pain and numbness, heal wounds, and restore damaged tissue on the feet and legs.
People who suffer from severe PAOD of the legs often experience severe pain even while at rest as well as chronic wounds that won't heal, numbness, a burning sensation in their lower limbs, and gangrene that can lead to amputation. Traditionally, physicians attempt to treat these patients with surgical bypass/revascularization and angioplasty. In many cases, however, these procedures cannot be applied. Drug therapy is also ineffective for severe PAOD. Amputation of the lower leg is often the only solution for a large number of patients.
Temple University Hospital is a 405-bed, world-renowned medical center and flagship institution for a fully integrated health care system with more than 1,000 beds and 1,300 physicians. Temple University Health System, which includes several area hospitals, nursing homes and outpatient centers, serves patients from the Delaware Valley and beyond while fulfilling its mission of teaching, research and affordable health care for all.
Each year, Temple treats approximately 20,000 inpatients and handles 150,000 outpatient visits at its clinics and outpatient facilities. With well-respected programs in cardiology and cardiac surgery, pulmonary medicine, orthopedics and sports medicine, neurology, neurosurgery, OB/GYN, organ transplantation and gastroenterology, Temple's network of physicians, nurses and facilities are trained and equipped for any situation.
RPR Gencell is the division of Rhône-Poulenc Rorer (RPR) Dedicated to the discovery, development, manufacture and commercialization of gene therapy products. Established in 1994, RPR Gencell is currently developing several gene therapy product candidates in the therapeutic areas of Oncology and Cardiology. RPR Gencell's rapid development is due, in part, to its commitment to building partnerships with innovative researchers, such as Introgen, throughout the world to accelerate the application of gene therapy for unmet medical needs. Rhône-Poulenc Rorer is a global pharmaceutical company dedicated to improving human health. Rhône-Poulenc S.A. (NYSE:RP) is a leading life sciences company, growing through innovations in human, plant and animal health and through its specialty chemicals subsidiary, Rhodia. With sales in 1998 of FF:86.8 billion (US$14.8 billion; Euros 13.232 billion), the company employs 65,000 people in 160 countries worldwide. The RPR Internet web site is at http://www.rp-rorer.com.