Allovectin-7 For Melanoma Treatment Passes Third Safety Analysis

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Vical Incorporated announced today that an independent Safety Monitoring Board (SMB) for the company's Phase 3 AIMM trial of Allovectin-7(R) in patients with metastatic melanoma has completed the trial's third scheduled safety analysis and recommended that the trial continue per the protocol. The trial is expected to complete enrollment of the planned 375 subjects in the next few weeks. Allovectin is used for melanoma treatment.

Allovectin-7® is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and ß2 microglobulin. In 1999, Allovectin-7® was granted orphan drug designation for the treatment of invasive and metastatic melanoma by the FDA’s Office of Orphan Products Development.

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In the 2003 Phase 2 AIMM (Allovectin-7(r) Immunotherapeutic for Metastatic Melanoma) trial evaluating the Allovectin-7® immunotherapeutic alone for patients with stage III or stage IV melanoma, the data showed that the trial had a total of 15 responders among the 127 patients receiving the high dose (11.8%). Four of the patients had complete responses and 11 had partial responses. Median survival was 18 months. There were no adverse events associated with Allovectin-7® during the Phase 2 trial.

Enrollment in the Phase 3 trial began in January 2007 and will come to an end in early January 2010. The Phase 3 trial involves patients at approximately 60 clinical sites worldwide. The Phase 3 trial calls for enrollment of approximately 375 patients with recurrent metastatic melanoma. Patients may have been previously treated with surgery, adjuvant therapy, and/or biotherapy, but cannot have been previously treated with chemotherapy. The patients were randomized on a 2:1 basis; approximately 250 patients will be treated with Allovectin-7® and approximately 125 will be treated with their physician’s choice of either of two chemotherapy agents, dacarbazine or temozolomide. The primary endpoint is a variation on progression-free survival that compares the two trial arms for objective responses that are ongoing at six months or more after randomization. The study will also evaluate safety and tolerability as well as survival as secondary endpoints.

It is estimated by the American Cancer Society that approximately 62,000 new diagnoses of malignant melanoma occur each year in the United States. There are approximately 8,400 deaths from melanoma each year. Overall, the lifetime risk of getting melanoma is now approximately 2% (or 1 in 50) for Caucasians. Currently, there are no consistently effective therapies for advanced cases of melanoma where the cancer has spread beyond its site of origin, or metastasized. Treatment for these patients normally includes a combination of chemotherapy, radiation therapy, and surgery. In patients with advanced metastatic melanoma, median survival typically ranges from six to ten months.

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