Vical Inc announced the receipt of a $2.5 million cash payment from AnGes MG Inc, related to continued progress in the company's ongoing Allovectin-7(r) phase-3 metastatic melanoma trial. Through a series of cash payments and equity investments under a previously announced collaborative agreement, Vical has received $20.1 million to date of the $22.6 million total committed by AnGes. The trial is expected to complete enrollment of the planned 375 subjects by year-end 2009.
"Our recruitment of patients is going very well in this pivotal phase-3 trial as we gain momentum at existing clinical sites and continue adding new sites," said Vijay B Samant, Vical's president and chief executive officer. "We are actively enrolling at 85 sites in more than a dozen countries in key geographic regions around the world, and are on track to complete enrollment of the planned 375 patients by the end of the year." Ei Yamada, AnGes' president and chief executive officer, said, "We are pleased to be working with Vical on this important program, and excited that the trial is nearing completion. We hope for a positive outcome that would support approval in the United States and provide an opportunity for us to expand in the Asian market."
Vical is conducting the AIMM (Allovectin-7 Immunotherapeutic for Metastatic Melanoma) phase-3 pivotal trial targeting enrolment of approximately 375 patients with Stage III or IV metastatic melanoma. In exchange for funding the trial, AnGes received exclusive marketing rights in Japan and other key Asian countries, and also will receive certain royalties for sales in the United States and European countries. AnGes is obligated to pay Vical royalties on product sales in the specified Asian countries, plus certain sales-based milestone payments if defined sales levels are achieved. Vical is obligated to pay AnGes tiered royalties based on defined sales levels in the United States, and fixed royalties on rest-of-world sales. Each company will be responsible for obtaining regulatory approvals in any countries where it plans to market Allovectin-7(r).
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.