DULUTH, GA. — The U.S. Department of Agriculture approved the first conditional license for a cancer therapeutic vaccine from Merial Ltd.
The vaccine ranks as the world's first for animals or humans, explains Dr. Bob Menardi, Merial's manager of technical services.
The therapeutic vaccine will make its way to market this month as a treatment for stage II or stage III oral melanoma in dogs.
Available through boarded oncologists, the conditional license from USDA represents a milestone, Menardi says. "This vaccine
is an example of how human medicine and veterinary medicine can work together for the benefit of both species," he adds.The
vaccine represents a decade-long collaboration with researchers at New York's Animal Medical Center (AMC) and Memorial Sloan-Kettering
Robert Nordgren, Merial's vice president for biological research and technology acquisition, explains that the DNA vaccine
alerts the immune system to the presence of the melanoma tumor protein tyrosinase. The gene for human tyrosinase protein is
inserted into a DNA plasmid, which in turn stimulates an immune response in the canine patient suffering from melanoma.
"The earlier you begin immunotherapy the greater the chances for survival," Nordgren adds.
The vaccine shows promising improvements in survival times when compared to surgery and radiation. In fact, in a Phase I clinical
trial of dogs with advanced malignant melanoma after DNA vaccination with xenogeneic human tyrosinase, the median survival
time was 389 days for dogs with stages II, III or IV canine melanoma receiving four biweekly vaccinations. In comparison,
the historical median survival time for dogs with stage II oral melanoma is less than 150 days; for dogs with stage II or
stage IV it is less than two to three months.
Studies demonstrating efficacy and safety were conducted by AMC's Philip Bergman, DVM, MS, PhD, Dipl. ACVIM. His studies from
2000 to present have shown an increase in survival times.
Research for a conditional license demonstrates "a reasonable expectation of safety," Menardi says. Follow-up studies are
ongoing to pursue full licensure and further support safety and efficacy of the vaccine.
For oncologists using the treatment, the vaccine is administered using a canine transdermal device. The Canine Melanoma Vaccine
is administered in a 0.4mL dose volume. The injection site for all dogs is the muscle of the medial thigh just caudal to the
femur. Initial treatment requires four doses of vaccine at two-week intervals. A booster dose should be administered at six-month
intervals, the company says.
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