Advanced Melanoma Skin Cancer Drug Allovectin-7 to Continue Late-Stage Trials

An independent safety monitoring board announced positive findings on December 28, 2009, for the continuation of Phase III trials of the experimental cancer drug Allovectin-7 Immunotherapeutic. Allovectin-7 is currently involved in late-stage trials to treat patients with advanced cases of melanoma, a potentially fatal form of skin cancer with a median survival rate of six to 10 months.

Under joint development by Vical Inc. and Japanese-based AnGes MG Inc., Allovectin-7 is an immunotherapeutic agent that works with the body’s immune system to train it to recognize and destroy tumor cells, causing cancerous tumors to shrink or disappear completely. The drug would offer an alternative to traditional chemotherapy treatments, with injections of Allovectin-7 given weekly directly into tumors.

Phase III clinical trials of Allovectin-7 will finish enrolling patients by January 2010 at approximately 60 clinical sites worldwide. The study will involve 375 patients with metastasized melanoma who have not previously received chemotherapy treatment. Researchers hope to see if more patients with the advanced skin cancer will respond favorably to Allovectin-7 alone than to current chemotherapy options.

Phase II trials from 2003, called AIMM (Allovectin-7 Immunotherapeutic for Metastatic Melanoma), reported no adverse events with the immunotherapy treatment. Allovectin-7 was granted orphan drug status by U.S. Food and Drug Administration (FDA) health regulators in 1999, giving the drug marketing exclusivity for seven years in the U.S. upon FDA approval. If approved, the drug will offer an alternative to current treatment options for advanced skin cancer patients which include chemotherapy, radiation therapy, and surgery.

Allovectin-7 Immunotherapy offers help for patients with stage III or stage IV melanoma, where the cancer has spread beyond the original site to nearby skin or lymph nodes or to internal organs.

The American Cancer Society estimates there were nearly 69,000 new diagnoses of malignant melanoma in 2009, with a reported 8,650 yearly deaths. Melanoma is a type of skin cancer that affects the melanocyte cells that produce the skin pigment melanin. Skin cancer is the most common form of cancer, with about 1 million cases of non-melanoma skin cancer cases diagnosed each year.