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news.Genzyme shares have risen by close to 2% after the company announced that the first patient has been treated in a new phase II clinical trial examining the safety and effectiveness of its experimental gene therapy in peripheral arterial disease.
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Genzyme’s experimental therapy, using Ad2/HIF-1 alpha, an engineered form of the HIF-1 alpha gene, is designed to promote the growth of new blood vessels and improve circulation in patients’ limbs.
The trial, a randomized double blind placebo controlled study, will take place at up to 35 medical centers in the US and Europe. It will enroll up to 300 patients diagnosed with severe intermittent claudication, a type of peripheral arterial disease that results in disabling pain or fatigue in the legs, brought on by exercise.
In addition to safety, the trial will evaluate the effectiveness of each dose in several measures of efficacy. The primary endpoint is change in the maximum amount of time a patient can walk on a treadmill without stopping due to claudication symptoms.
The phase II clinical trial builds on a successful phase I trial, which demonstrated evidence of safety at several doses in patients with critical limb ischemia, a more severe form of peripheral arterial disease. Investigators also reported preliminary evidence of bioactivity, with a trend in favor of the higher doses studied.