Vical Highlights Transition To Phase 3 Trial With Allovectin-7(R) For Metastatic Melanoma

Main Category: Melanoma / Skin Cancer
Also Included In: Clinical Trials / Drug Trials
Article Date: 25 Jan 2007 - 0:00 PDT

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Vical Incorporated (Nasdaq: VICL) presented today the process followed by the company in advancing its Allovectin-7(R) 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., Ph.D., Vical's Senior Vice President of Product Development, in a presentation titled "Transitioning Plasmid-based Products from Phase 2 to Phase 3: Allovectin-7(R) Case Study," at the Phacilitate Cell and Gene Therapy Forum in Baltimore, Maryland.

The company announced earlier this month the initial treatment of the first patient in the Phase 3 pivotal trial of Allovectin-7(R) 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 U.S. Food and Drug Administration (FDA) at up to 50 clinical sites. AnGes MG, Inc., will fund the clinical trial through a combination of sponsored development and purchases of Vical common stock.

"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 Chief Executive Officer. "The Phase 3 AIMM trial will allow head-to-head comparison of our Allovectin-7(R) 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(R) treatment cycles. We are now focused on enrolling patients as quickly as possible and completing the trial in strict adherence to the protocol."

About Vical

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. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at http://www.vical.com.

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether Vical or others will continue development of Allovectin-7(R); whether Allovectin-7(R) will achieve the Phase 3 trial endpoints and a clear path to approval; whether Vical will be able to recruit patients into the AIMM trial as planned, if at all; whether the results from the completed Phase 2 trial are indicative of results in any future testing; whether Vical will receive all of the clinical trial funding from AnGes under the collaborative agreement, which will depend on continued development of Allovectin-7(R) and certain other conditions, as well as AnGes' compliance with its contractual obligations under the agreement; whether Allovectin-7(R) or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; whether defined sales levels will be achieved in any markets; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

Vical Incorporated
http://www.vical.com

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