Vical Inc. (VICL) announced recently that its cancer drug candidate Allovectin-7 has received a positive opinion from an independent safety review board. The board recommended the continuation of the late-stage study of Allovectin-7.
The study is being funded by Japan’s AnGes MG Inc., who has paid Vical the entire $22.6 million under the agreement. AnGes will exclusively market the drug in Japan and other key Asian countries on approval.
The safety monitoring board reached its decision that the trial be continued as per protocol after completing the study’s third scheduled safety analysis. The candidate is being evaluated for treating patients suffering from metastatic melanoma, a serious form of skin cancer.
Vical is currently enrolling patients for the late-stage study at sites in key centers worldwide. In the next few weeks, the company expects to complete the target enrollment of 375 chemotherapy-naive patients suffering from stage III or IV metastatic melanoma.
The study is being conducted according to a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The SPA specifies the objectives of the study in addition to the design, clinical endpoints and planned analyses needed for the product to get approved.
Allovectin-7 has already received an orphan drug designation for the treatment of invasive and metastatic melanoma from the U.S. agency, thereby granting Vical marketing exclusivity of seven years in the United States on approval. The drug, which gets directly injected into tumors, is designed so as to fuel an immune response against both local and distant metastatic tumors.
Allovectin will compete with ipilimumab of Bristol-Myers Squibb (BMY) on hitting the market. Ipilimumab is in late-stage development for the same indication.
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