USDA Grants Conditional Approval for First Therapeutic Vaccine to Treat Dog Cancer

Merial, the world's leading animal health company, gained conditional approval from the U.S. Department of Agriculture for a breakthrough vaccine to treat canine melanoma, a common yet deadly form of cancer in dogs. This is the first time that the U.S. government has approved a therapeutic vaccine for the treatment of cancer -- in either animals or humans.

The vaccine will initially be available for use by specialists practicing veterinary oncology, so pet owners will want to ask their veterinarians about how to access this treatment option.

The vaccine was developed through a partnership between Merial, Memorial Sloan-Kettering Cancer Center (MSKCC) and The Animal Medical Center (AMC) of New York. Drs. Alan Houghton and Jedd Wolchok of MSKCC were doing laboratory testing of a melanoma vaccine they developed. An inquiry by Dr. Philip Bergman of The AMC, seeking novel treatments for canine melanoma, resulted in the clinical trial of the Memorial Sloan-Kettering melanoma vaccine at The Animal Medical Center. Subsequent parallel trials at AMC and MSKCC refined the dosage and protocol to the current therapeutic regimen for dogs.

"Both humans and dogs develop this cancer in exactly the same way. The disease occurs spontaneously through an interaction of genes with the environment," explained Jedd D. Wolchok, MD, PhD, an oncologist on the Clinical Immunology Service at Memorial Sloan-Kettering. "By conducting trials in humans and in animals that live in the same surroundings as humans, there can be a synergy that we hope will result in improved cancer treatment for all."

Canine melanoma is an aggressive form of cancer that typically appears in a dog's mouth, but also may appear in the nail bed, foot pad or other areas. Dogs with melanomas that have gone beyond initial stages typically have a lifespan of one to five months with conventional therapies. To date, the most common treatments for this form of cancer have been radiation and surgery. "Melanoma spreads readily, and, unfortunately, is often resistant to chemotherapy," said Bob Menardi, DVM, a veterinarian and spokesperson
for Merial.

Clinical studies of the vaccine in dogs led by Philip Bergman, DVM, MS, PhD, Dipl. ACVIM-Onc. at The Animal Medical Center's Donaldson-Atwood Cancer Center and Flaherty Comparative Oncology Laboratory, demonstrated significantly longer life spans even in dogs with advanced stages of melanoma. In fact, many dogs have survived beyond the 389-day median survival of the initial study.

"Historically speaking, treatment of oral melanoma with surgery, radiation or chemotherapy has not been very effective," said Dr. Bergman. "This therapeutic vaccine is an adjunct therapy for dogs that have been
diagnosed with this often fatal disease."

Merial obtained licensing rights from MSKCC and AMC, and, using their access to and experience with DNA vaccine technology licensed from Vical Incorporated (Nasdaq: VICL), completed the industrialization and regulatory requirements for conditional licensure. The vaccine will be administered via a new Canine Transdermal Device, which delivers the vaccine without the use of a needle. The device was developed in conjunction with Bioject, a Portland- based research pharmaceutical device company (Nasdaq: BJCT).

"We're all very proud of what we've accomplished here," said Tim Leard, DVM, PhD, Director of Biologics Research and Development at Merial. "We've brought together a number of partners, all committed to innovation and discovery. This product will improve the health and well-being of dogs, and we're very excited about continuing this work, leveraging technology, and developing more treatments."

The USDA has issued a conditional U.S. Veterinary Biological Product License for this therapeutic vaccine. This conditional license is a response to an application and assurance of safety and purity, and a
reasonable expectation of efficacy based on initial trials performed at MSKCC and AMC.

During the period of conditional licensure, Merial will conduct additional research to further support the safety and efficacy of the vaccine. Production under this license is in compliance with all regulations and standards applicable to such products.