US drug developer Vical says that an independent Safety Monitoring Board for the company's Phase III AIMM trial of Allovectin-7 in patients with metastatic melanoma has completed its second scheduled safety analysis and recommended that the trial continue. The trial is expected to complete enrollment of the planned 375 subjects by the end of 2009.
Vical is conducting the AIMM study, a pivotal trial of its cancer immunotherapeutic as first-line therapy in approximately 375 chemotherapy-naive patients with Stage III or IV metastatic melanoma in accordance with a Special Protocol Assessment agreement completed with the US Food and Drug Administration.
Under a previously-announced collaborative agreement, Japanese firm AnGes MG is funding the AIMM trial through a series of cash payments and equity investments. Vical has received $17.6 million to date of the $22.6 million total committed by AnGes.
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