Vical Incorporated has presented the process in advancing its Allovectin-7 cancer immunotherapeutic from a successful phase 2 trial into a phase 3 pivotal trial designed to support regulatory approval.
The detailed process was described by Alain P Rolland, Pharm D, PhD, Vical's senior vice president of product development, in a presentation titled "Transitioning Plasmid-based products from phase 2 to phase 3: Allovectin-7 Case Study," at the Phacilitate Cell and Gene therapy forum in Baltimore, Maryland.
The company has announced earlier this month the initial treatment of the first patient in the phase 3 pivotal trial of Allovectin-7 as first-line therapy in chemotherapy-naive patients with recurrent stage III or IV metastatic melanoma. The trial, known as AIMM (Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma), will be conducted in accordance with a Special Protocol Assessment (SPA) completed with the US Food and Drug Administration (FDA) at up to 50 clinical sites.
"Through the SPA process, we reached agreement with the FDA on a feasible phase 3 trial design with what we believe are achievable endpoints providing a clear path to approval," said Vijay B Samant, Vical's president and CEO. "The phase 3 AIMM trial will allow head-to-head comparison of our Allovectin-7 immunotherapy against chemotherapy in a protocol designed to reveal the potential advantages of our product candidate. The primary endpoint is a comparison of objective response rates after six months, which will allow completion of at least two full Allovectin-7 treatment cycles. We are now focused on enrolling patients as quickly as possible and completing the trial in strict adherence to the protocol."
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor.