Vical Incorporated Initiates Pivotal Phase 3 Trial Of Allovectin-7(R) As First-line Therapy For Metastatic Melanoma

04 Jan 2007
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SAN DIEGO, Jan. 4 /PRNewswire-FirstCall/ -- Vical Incorporated announced today the initiation of a Phase 3 pivotal trial of the company's Allovectin-7(R) cancer immunotherapeutic 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 under a collaborative agreement with Vical. "We are excited to begin the AIMM head-to-head superiority trial against first-line chemotherapy," said Robin M. Jackman, Senior Vice President of Business Operations at 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. With a primary endpoint of durable response rate, we can complete the trial after scheduled follow-up for the last patient without having to wait for long-term survival data. We are working aggressively to enroll patients into this trial and advance this novel product toward commercialization in collaboration with AnGes." Because of substantial unmet medical need, Allovectin-7(R) has been granted orphan drug designation for the treatment of invasive and metastatic melanoma by the FDA's Office of Orphan Products Development. Orphan drug designation provides U.S. marketing exclusivity for seven years upon marketing approval by the FDA, in addition to certain tax benefits for qualifying expenses. The AIMM 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 will be randomized on a 2:1 basis: approximately 250 patients will be treated with Allovectin-7(R) 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 comparison of objective response rates at six months or more after randomization. The study will also evaluate safety and tolerability as well as survival. Further information on the trial is available through the company's web site at or at the National Institutes of Health (NIH) clinical trials web site at . About Allovectin-7(R) Allovectin-7(R) is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and beta-2 microglobulin, which together form a Class I Major Histocompatibility Complex, or MHC-I antigen. Injection of Allovectin-7(R) directly into tumors is designed to stimulate an immune response against both local and distant metastatic tumors. Vical conducted a large Phase 2 trial evaluating Allovectin-7(R) immunotherapeutic as a single agent for patients with Stage III or IV metastatic melanoma. Based on advice from clinical experts and detailed guidance received from the FDA in an End-of-Phase 2 meeting, Vical successfully completed a SPA with the FDA for a Phase 3 trial of Allovectin-7(R) for certain patients with metastatic melanoma. The SPA specifies that the trial design and planned analyses address the study's objectives and the resulting study data could provide the primary basis to support a product license application. About Metastatic Melanoma The American Cancer Society estimated that approximately 62,000 new diagnoses of, and approximately 7,900 deaths from, melanoma would occur in 2006 in the United States. Currently, there are no consistently effective therapies for advanced cases of malignant melanoma where the cancer has spread to other parts of the body. The toxicity associated with FDA-approved treatments such as dacarbazine or interleukin-2 is often significant, resulting in serious or life-threatening side effects in many of the patients treated. Patients with metastatic melanoma often are treated off-label with drugs such as temozolomide, which has been approved by the FDA for the treatment of certain types of brain cancer but not for the treatment of metastatic melanoma. Temozolomide is an orally-delivered pro-drug that converts in the body into the same active compound as dacarbazine. 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 immunotherapeutics for cancer, in which the expressed protein is an immune system stimulant; DNA vaccines for infectious diseases, in which the expressed protein is an immunogen; 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 serve significant unmet medical needs. Additional information on Vical is available at . 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 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 Vical will receive any or all of the sales-based milestone payments and royalties for sales in the countries specified in the agreement, which will depend on the efforts of AnGes in obtaining regulatory approval and commercializing Allovectin-7(R) in those countries; whether Vical or others will evaluate potential additional applications of the company's technology; 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. Contacts: Investors: Media: Alan R. Engbring Susan Neath Vical Incorporated Porter Novelli Life Sciences (858) 646-1127 (619) 849-6007 Website: Vical Incorporated CONTACT: Investors, Alan R. Engbring of Vical Incorporated,+1-858-646-1127; or Media, Susan Neath of Porter Novelli Life Sciences,+1-619-849-6007, for Vical Incorporated Web site:
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