FORT COLLINS — VetDC Inc., a veterinary cancer-therapeutics company based in Fort Collins, said Wednesday it has been granted conditional approval of Tanovea-CA1, a treatment of lymphoma in dogs, from the U.S. Food and Drug Administration’s Center for Veterinary Medicine.
The company said it expects that the drug will be available to veterinarians this spring.
“This is a significant milestone for VetDC, and we are excited to announce the first ever FDA-approved drug for canine lymphoma,” Steven Roy, VetDC’s president and chief executive, said in a prepared statement.
Through its clinical trials for animal patients, Colorado State University helped prove the usefulness of the drug.
“Across the board, we saw some positive activity in up to 80 percent of all the lymphoma patients that were treated with this medication,” said Dr. Doug Thamm, a veterinarian and cancer researcher who led clinical trials at CSU’s Flint Animal Cancer Center.
Dr. Philip J. Bergman, a board-certified veterinary oncologist at VCA-Katonah Bedford Veterinary Center in Bedford Hills, N.Y., said the conditional approval of Tanovea-CA1 represents a first on multiple levels for veterinary oncology.
“We eagerly anticipate adding this very active and promising new drug to our lymphoma fighting arsenal,” he said.
Tanovea was discovered by Gilead Sciences Inc., a research-based biopharmaceutical company, and was originally designed to treat lymphoma in human patients. Thamm worked with Gilead years ago to study the molecule that ended up becoming Tanovea-CA1. “We were initially trying to determine whether it was effective in preparation for human development,” he explained.
Gilead decided not to pursue human clinical development of the drug, and VetDC acquired the animal-health rights.
Lymphoma is one of the most common types of cancer in dogs. It originates from white blood cells called lymphocytes. These cells are a normal part of the immune system and protect the body from infection, but in lymphoma, they grow abnormally.
Although lymphoma can affect virtually any organ in the body, it most commonly starts in organs that function as part of the immune system, such as the lymph nodes, spleen and bone marrow. The signs of lymphoma in dogs vary depending on which organs are affected. The cause of canine lymphoma is unknown.
Tanovea-CA1 has demonstrated anti-tumor activity in both naïve and relapsed canine lymphoma cases, with a generally well-tolerated safety profile. Tanovea-CA1 is administered intravenously every three weeks for up to five doses.