SAN DIEGO, April 23 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today announced the release to television news stations nationwide of an independently produced video report featuring metastatic melanoma patients treated with the company's Allovectin-7(R) immunotherapeutic product candidate. The report is expected to be used broadly by stations in cities with clinical sites participating in Vical's Phase 3 Allovectin-7(R) trial, and in other cities by stations promoting melanoma awareness in May, which is National Melanoma/Skin Cancer Detection and Prevention Month. The two-minute video report was produced by MAX World News and is available by satellite feed to subscribing stations.
The video report features interviews with an oncologist and two of his patients who participated in earlier trials of Allovectin-7(R). Both patients had been treated previously with approved therapies and had refractory metastatic melanoma before receiving Allovectin-7(R). One patient had several metastatic tumors, including three in the liver, and had been advised that he should expect to live only three months. The other patient had a single metastatic tumor in a lymph node. Following treatment with Allovectin-7(R), both of these patients had complete remissions and have now been cancer-free for six and eight years, respectively.
Allovectin-7(R) is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and .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 U.S. Food and Drug Administration (FDA) in an End-of-Phase 2 meeting, Vical successfully completed a Special Protocol Assessment (SPA) with the FDA for a Phase 3 trial (the Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma, or AIMM trial) for certain patients with Stage III or Stage IV melanoma. The SPA agreement 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.
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 if marketing approval is received from the FDA, in addition to certain tax benefits for qualifying expenses.
Patients featured in the video report were selected from complete responders in earlier trials, and do not represent the majority. In the Phase 2 study, the overall response rate was 11.8%, including 11 partial responders and 4 complete responders from the 127 patients treated. The drug-related side effects in the Phase 2 study were predominantly mild and temporary, including pain and inflammation at the injection site and flu-like symptoms such as fatigue, fever, muscle and joint pain, and headache.
About the AIMM Trial
In early 2007, Vical initiated a Phase 3 pivotal trial of the company's Allovectin-7(R) cancer immunotherapeutic as first-line therapy in chemotherapy-naive patients with Stage III or IV metastatic melanoma. The AIMM trial is being conducted in accordance with the SPA agreement at more than 60 clinical sites, and is currently enrolling patients in the United States, Canada and Europe. AnGes MG, Inc., is funding the clinical trial under a collaborative agreement with Vical.
The AIMM trial calls for enrollment of approximately 375 patients with Stage III or IV metastatic melanoma. Patients may have been previously treated with surgery, adjuvant therapy, and/or biotherapy, but cannot have been previously treated with cytotoxic 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 variation of progression-free survival, specifically comparison of objective response rates at six months or more after randomization. The study will also evaluate safety and tolerability as well as overall survival. A patient self-screening tool for trial eligibility is available online at http://www.melanomaclinicaltrial.com.
About Metastatic Melanoma
The American Cancer Society has estimated that more than 62,000 new diagnoses of, and approximately 8,400 deaths from, melanoma will occur in 2008 in the United States. Currently, there are no consistently effective therapies for advanced cases of metastatic 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.
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 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 Vical will be able to recruit patients into the AIMM trial as planned, if at all; whether the results from the Phase 2 trial or those reflected in the video report are indicative of results in any future testing of Allovectin-7(R); 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 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.
Contact: Alan R. Engbring
|SOURCE Vical Incorporated|
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