Vical to start phase 3 melanoma trial with Allovectin-7

By Elaine Rigoli

Tampa, Fla., Sept. 25 - Vical, Inc. said Monday that it will start a phase 3 trial for melanoma soon using the company's Allovectin-7, focused on stage 3 and stage 4 melanoma patients.

The company said the primary endpoint is objective response rate, not survival, during the course of a 16-week cycle, including two six-week cycles of treatment with two-week cycles of observation.

The trial is fully funded by Osaka, Japan-based AnGes MG Inc., which is providing $23 million to fund the trials, which covers all licensing rights in Japan.

Vical said its only responsibility is to provide clinical data.

Under a Special Protocol Assessment with the Food and Drug Administration, this study is being conducted in chemotherapy-naïve patients.

The product will launch in 2007, president and chief executive officer Vijay Samant said during the UBS Global Life Sciences conference.

The San Diego infectious disease company said it has 15 active development programs, spending close to $100 million in clinical trials.

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