Vical Incorporated announced the receipt of a $2.3 million cash payment from AnGes MG, Inc, related to continued progress in the company's ongoing Allovectin-7 phase-3 metastatic melanoma trial. Through a series of cash payments and equity investments under a previously announced collaborative agreement, Vical has received $17.6 million to date of the $22.6 million total committed by AnGes. The trial is expected to complete enrolment of the planned 375 subjects by year-end 2009.
"We are making great progress recruiting patients as we continue to expand beyond North America to clinical sites across Western and Eastern Europe, into Israel, and recently into Turkey with the help of our commercialization partner Eczacibasi," said Vijay B Samant, Vical's president and chief executive officer. "Including our sites in the United States and Canada, we expect to have more than 100 active clinical sites in key centres worldwide as we advance toward our final months of enrolment. Based on the trends across these regions, we are confident that we will complete enrolment in this pivotal Phase 3 trial by the end of the year."
Vical is conducting the AIMM (Allovectin-7(r) Immunotherapeutic for Metastatic Melanoma) phase-3 pivotal trial targeting enrolment of approximately 375 patients with Stage III or IV metastatic melanoma. A patient self-screening tool for trial eligibility is available online at www.melanomaclinicaltrial.com.
Ei Yamada, AnGes' president and chief executive officer, said, "We are very pleased by the progress Vical has made to date and encouraged that they will be completing enrolment in the Allovectin-7(r) trial by the end of the year." 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.