CLINICAL TRIAL RESULTS SUGGEST RECOMBINANT DNA GENE THERAPY IS A SAFE AND EFFECTIVE TREATMENT FOR PATIENTS WITH "INOPERABLE" HEART DISEASE

Phase 1 Findings Presented During The Society Of Thoracic Surgeons' 35th Annual Meeting In San Antonio, TX, Indicate That The Injection Of phVEGF165 Directly Into A Patient's Heart Helps To Significantly Reduce Angina Episodes

(San Antonio, TX) – Patients who are ineligible for bypass surgery to treat their heart disease may benefit from an experimental genetic compound according to results from a Phase 1 clinical trial presented today at the 35th Annual Meeting of The Society of Thoracic Surgeons. Evidence from the trial suggests that when the compound known as phVEGF165 is injected directly into the heart of a patient with heart disease, it helps increase the amount of blood flowing to the heart's primary muscles and provides significant relief of angina.

Dr. James Symes, a cardiothoracic surgeon with St. Elizabeth's Medical Center in Boston, MA, and colleagues examined the effectiveness of phVEGF165 in treating inoperable cases of heart disease. The compound was delivered to each patient via non-heart bypass surgery that consisted of four injections into separate sites of each patient's heart. To date, 20 patients are participating in the trial in two groups with each group of 10 patients receiving different amounts of the compound. The first group received a dose of phVEGF165 that was half the dose provided to the second group. The trial to date has shown a steady and consistent improvement for 19 of the 20 patients in the trial. There was one late death in the trial from pneumonia that occurred approximately four months postoperatively.

Prior to surgery the group of patients as a whole experienced an average of 60 episodes of angina per week and consumed an average of 60 nitroglycerin tablets to battle the angina. 30 days after treatment the group's angina episodes dropped to an average of 12.6 per week, nitroglycerin consumption dropped to an average of 8 tablets, and 6 patients, or 30%, were angina free. 60 days after treatment the group experienced an average of 7.2 episodes of angina per week, nitroglycerin consumption fell to an average of 4.8 tablets per week, and 6 patients, or 33%, were angina free. 180 days after treatment the group experienced an average of 3.5 episodes of angina per week, nitroglycerin consumption fell to an average of 2.2 tablets per week, and 7 patients, or 70% of the cases in the category, were angina free.

Dr. Symes adds, "Our results are very encouraging for patients suffering from inoperable cases of heart disease. While the data presented is preliminary, it strongly suggests that the use of this recombinant DNA genetic therapy technology could become a major advancement in the treatment of heart disease."

The Society of Thoracic Surgeons is the membership society for thoracic surgeons in the United States. With over 4,100 members, the society represents the surgical practice areas of cardiac surgery (heart), general thoracic surgery (pulmonary, lung, esophagus, and mediastinum), pediatric thoracic surgery, and transplant surgery. The society is committed to saving, extending, and improving the quality of life for all Americans.