Tuesday, January 12, 2010

USDA Approves Therapeutic Melanoma Vaccine for Dogs

Vical Announces Licensee's Approval of ONCEPT(TM) Therapeutic Melanoma Vaccine for Dogs

Vical Incorporated (Nasdaq:VICL) announced that the U.S. Department of Agriculture (USDA) has granted the company's licensee Merial Limited, the animal health subsidiary of sanofi-aventis, full licensure for its ONCEPT(TM) canine melanoma vaccine, a therapeutic DNA vaccine designed to aid in extending survival of dogs with oral melanoma. Merial plans to launch the product at the North American Veterinary Conference (Orlando, January 16 - 20).

"The approval of ONCEPT(TM) is a milestone in the cancer vaccine field and a significant advancement for our DNA delivery technology platform," said Vijay B. Samant, Vical's President and Chief Executive Officer. "Therapeutic vaccines -- the holy grail of vaccinology -- are delivered after disease onset to impede disease progress for the patient's benefit. ONCEPT(TM) is to our knowledge the only therapeutic vaccine approved, and we believe this achievement is a major step toward the initial approvals of therapeutic vaccines for humans. We also believe that regulatory acceptance of ONCEPT(TM) bodes well for similar product candidates such as our Allovectin-7(R) DNA-based immunotherapeutic for patients with metastatic melanoma. ONCEPT(TM) uses a xenogeneic approach and Allovectin-7(R) uses an allogeneic approach, both employing the immune system's self/non-self recognition ability to drive a potent immune response against melanoma. Through our independent and partnered programs, we are advancing well toward additional approvals of DNA-based products."


The ONCEPT(TM) canine melanoma vaccine contains a gene encoding human tyrosinase, an enzyme associated with skin pigmentation. The tyrosinase produced from the human DNA used in this vaccine is similar to canine tyrosinase and has been shown to stimulate an immune response against canine melanoma cells producing tyrosinase. The use of DNA from a noncanine species causes production of tyrosinase that is considered foreign by the canine immune system (thereby stimulating a potent immune response), yet is similar enough to canine tyrosinase that the dog's immune response will target canine melanoma cells.

ONCEPT(TM) significantly extends survival time following primary tumor removal. Dogs with stage II or III malignant melanoma typically have survival times of less than six months when treated with surgery alone. In a controlled study, dogs vaccinated with ONCEPT(TM) following surgery had significantly better survival times than unvaccinated dogs (p<0.0001). Median survival time could not be determined for vaccinated dogs, since more than 50% of the treated dogs were still surviving at the time of publication of the study.

About Canine Melanoma

Melanoma is a common type of cancer in dogs and is the most common malignant tumor of the dog's mouth and can also occur in the nail and footpad. Canine oral melanoma may affect any breed and is a highly aggressive cancer. Normal treatment for canine oral melanoma includes surgery and/or radiation, but even after successful local treatment, the melanoma frequently spreads throughout the body, including the lymph nodes, liver, lungs and kidneys, and is often resistant to chemotherapy.

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 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. Forward-looking statements include statements about Merial's ONCEPT(TM) canine melanoma therapeutic DNA vaccine, Vical's Allovectin-7(R) DNA-based human immunotherapeutic for metastatic melanoma, Vical's DNA delivery platform technology and its current and potential applications, as well as the company's focus, collaborative partners, and product candidates. Risks and uncertainties include whether Merial will successfully market ONCEPT(TM), and if so, to what extent; whether market success for ONCEPT(TM) will encourage development of other cancer vaccines and similar products; whether Vical's Allovectin-7(R) or any other product candidates under development by Vical or its collaborative partners, will be shown to be safe and effective in clinical trials or receive any regulatory approvals; 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; 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.

ONCEPT is a trademark of Merial.

Allovectin-7 is a registered trademark of Vical Incorporated.

CONTACT: Vical Incorporated
Alan R. Engbring
(858) 646-1127

1 comment:

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