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Two years after gene therapy treatments, severe angina patients showed prolonged clinical benefit

ss III or IV angina refractory to medical therapy who also had multivessel occlusive coronary artery disease not amenable to revascularization. Patients were treated in dose-escalating fashion at 200, 800 or 2,000 mg dose, injected directly into the heart muscle with a hypodermic needle after a mini-thoracotomy, a surgical incision in the chest wall.

Patients were followed for clinical events after one year by hospital records, follow-up visits or telephone contact. At the most recent follow-up, no patients had Class IV angina, and only three (11.5%) had Class II angina, while the remaining had Class I or II angina. Compared to baseline, average angina class decreased from 3.6 0.5 to 1.3 1.0 after the first year. This benefit persisted to 24 months when the mean angina class was 1.5 1.2 (p< 0.05).

Major clinical events such as death, myocardial infarction (MI, or heart attack) and repeat revascularization were uncommon during the first year but more frequent after one year at a rate consistent with the severity of the underlying disease in a population with advanced atherosclerosis. The majority of events were the result of progression of disease in areas of the heart remote from the site of injection.

Previous Clinical Data

Physicians who participated in the Phase I study published previous reports stating that the results demonstrated the safety of VEGF-2 and citing significant improvement in the exercise tolerance time in all dose groups. The study reports reflected that 80% of the patients treated experienced an improvement (decrease) in angina class of two or more levels and 40% of the patients experienced complete elimination of angina symptoms. Similarly, significant reductions in the number of angina episodes per week and the number of nitroglycerin tablets taken were observed. Given the invasive nature of this trial, there was not a control group that received a placebo.

The Phase I trial was followe
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Contact: Justin Jackson
jjackson@burnsmc.com
212-213-0006
Burns McClellan
8-Mar-2005


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