Pet owners, rejoice! There is yet another weapon in the fight against canine cancer. Vical Incorporated, a biopharmaceutical products R & D firm based in San Diego, CA, has announced that the USDA has granted its licensee, Merial Limited, full licensure for it’s ONCEPT(TM) canine melanoma vaccine. The product will be officially launched at the North American Veterinary Conference in Orlando later this month. Read the full press release below.
Vical Announces Licensee’s Approval of ONCEPT(TM) Therapeutic Melanoma Vaccine for Dogs
SAN DIEGO, Jan. 11, 2010 (GLOBE NEWSWIRE) — Vical Incorporated (Nasdaq:VICL) today 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.