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news.Vical has announced that its licensee, AnGes, has received FDA approval for its Special Protocol Assessment (SPA) agreement for a phase 3 clinical trial of its Collategene angiogenesis product, for patients with advanced peripheral arterial disease (PAD). The study will be multinational, randomized and placebo-controlled with a target population of 560 patients.
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The phase 3 trial will enroll no option as well as poor option patients with chronic and severe ischemia of the lower limb. No option patients are those unable to receive an endovascular intervention or surgical bypass procedure due to inflow, conduit or outflow reasons or due to a severe and irreversible co-morbidity, where surgery is contraindicated.
Poor option patients are those unable to receive an endovascular intervention and at high risk for bypass surgery due to their vascular anatomy or severe co-morbid disease. Inclusion of poor option patients will open the clinical trial to at least three to four times as many target patients, compared to other trials within the industry which only include no option patients.
Collategene uses Vical’s patented DNA technology to deliver a gene encoding hepatocyte growth factor (HGF), a human protein that causes growth of blood vessels when injected in areas of restricted blood flow. In March 2008, AnGes submitted a New Drug Application (NDA) for Collategene to the Japanese Ministry of Health, Labor and Welfare for treatment of CLI. The submission is under review.
AnGes has designed the new phase 3 trial to pursue approvals of Collategene in the US, Canada, Europe, Latin America and other markets beyond Japan.