The trial will be conducted in accordance with a special protocol assessment and AnGes MG will fund the clinical trial under a collaborative agreement with Vical.
“There is a great need for new treatment options in metastatic melanoma, where no new first-line therapies have been approved in nearly 15 years,” said Robin Jackman, senior vice president, Business Operations at Vical
Vical commented that the primary endpoint will be durable response rate, which means the trial can be completed after scheduled follow-up for the last patient without having to wait for long-term survival data. The study will also evaluate safety and tolerability as well as survival
Because of unmet medical need, Allovectin-7 has been granted orphan drug designation. Orphan drug designation provides US marketing exclusivity for seven years upon marketing approval by the FDA, in addition to certain tax benefits for qualifying expenses.