Dog Lymphoma Therapy OKd for Sale by USDA

A new therapy that is expected to more than double the life expectancy of dogs with lymphoma has been licensed for immediate sale by the U.S. Department of Agriculture, which regulates veterinary biologics.

The new therapy is particularly important, as it is the first immunotherapeutic monoclonal antibody to be approved for use to fight cancer in animals.

Although it has not yet received a trade name, the new therapy has been designated “canine lymphoma monoclonal antibody 231” (MAB 231) by the San Diego company responsible for its development, Synbiotics Corp. Synbiotics will be the sole manufacturer and marketer of MAB 231.

Conditional licensing of MAB 231 has been granted by the USDA following initial clinical trials that indicate that the new therapy increases the life expectancy of dogs afflicted with lymphoma, from six to 10 months with chemotherapy to an average of 17 months with chemoimmunotherapy, according to Synbiotics. Untreated dogs are not expected to survive more than four to six weeks.

Unconditional licensing is expected after the completion of clinical trials in major veterinary oncology research groups across the United States, according to the company.

These clinical trials indicate that the general health and vitality of afflicted dogs is improved by MAB 231 therapy.

The company estimates that more than 60,000 dogs are annually diagnosed as having canine lymphoma.

“MAB 231 therapy is administered after initial chemotherapy has brought the lymphoma into remission,” said Dr. Edward T. Maggio, Synbiotics’ president and chief executive officer. “With chemotherapy alone, expected survival for a dog with lymphoma is six to 10 months. With Synbiotics’ new product, we can extend that to an average of 17 months. This therapy also improves each dog’s quality of life during that extended time span.”

Maggio said MAB 231 was developed by Synbiotics based on the original research of Drs. K. Ann Jeglum and Zenon Steplewski of the Wistar Institute of Philadelphia.

Maggio said Synbiotics expects to introduce other new, proprietary therapies, diagnostics and vaccines for animals in the coming months as a result of the company’s collaborations with the Wistar Institute and other research organizations.

Veterinary’s first non-adjuvanted vaccine for feline leukemia was also introduced by Synbiotics. Vac/Syn FeLV was introduced in 1989 and is now in broad use throughout the United States, Maggio said.

Synbiotics was founded in 1982 to exploit breakthroughs in genetic engineering. In addition to its animal health business, the company also had created two other companies: UniSyn Fibertec and Immunopharmaceutics (IPI).

UniSyn Fibertec, which is now 54% owned by Synbiotics, is exploiting Synbiotics’ advances in the low-cost production of the mammalian cells necessary for genetically engineered pharmaceuticals.

IPI, which is now wholly owned by Synbiotics, uses the molecular information found in specially engineered antibodies to design orally active drugs for human cardiovascular diseases and inflammation-related diseases such as arthritis.