T-Cyte Launches First USDA-Approved Treatment Aid for Canine Osteoarthritis

MURRIETA, CA--(Marketwired - Oct 5, 2016) - T-Cyte Therapeutics, Inc., today announces the U.S. launch of Lymphocyte T-Cell Immunomodulator (LTCI) as the first USDA-approved treatment option for canine osteoarthritis (OA), a debilitating condition affecting 16-20 million dogs in the U.S. alone. The only biologic treatment aid for OA, LTCI is administered by veterinarians via an injection under the dog's skin and has been shown to increase the number and function of precursors of certain regulatory cells, thereby dampening the immune-mediated process associated with OA.

Earlier this year, based on the results of T-Cyte's double-blind, placebo-controlled study, USDA's Center for Veterinary Biologics granted conditional approval of LTCI's use as an aid in the treatment of osteoarthritis in dogs one-year and older. In this study, more than 90 percent of dogs that received LTCI demonstrated significantly improved mobility, as measured by objective force plate analysis.

LTCI, a naturally occurring biologic, affects the underlying immune-mediated disease process of canine OA, while current drug therapies for OA, including non-steroidal anti-inflammatory drugs (NSAIDs), are designed to treat only the symptoms of the disease. Additionally, LTCI is a safe treatment option for use in dogs who cannot use NSAIDs due to concomitant kidney, liver or heart problems, are elderly, or who have had previous negative reactions to NSAIDs. To date, there are no known contraindications associated with LTCI's use for canine OA treatment.

"Osteoarthritis in dogs is not simply a product of age-related wear and tear," said immunologist Terry Beardsley, Ph.D., CEO of T-Cyte. "OA appears to be an immune-mediated process similar to rheumatoid arthritis. In both humans¹ and dogs², scientific studies have shown that similar immune mediated processes are present in both diseases. We're taking this knowledge and completely changing the way OA has been treated in the past. Instead of simply alleviating symptoms, LTCI is designed to affect the fundamental mechanism of the disease."

"Dogs are our family, and they deserve the safest, most effective treatment possible," continues Beardsley. "LTCI is not a drug, but rather a naturally occurring protein that modulates the immune response to canine OA. Our goal is to give pets the same attention and treatment development that we do for humans, and create a safer alternative to help them live healthy lives."

To learn more about T-Cyte, place an order for LTCI or view the recommendations for canine OA treatment schedules, administration and patient monitoring, please visit http://tcyte.com/.

About T-Cyte

T-Cyte Therapeutics develops USDA-approved, innovative treatment solutions that safely address the needs of pets with immune-mediated diseases. T-Cyte is dedicated to providing safe, effective, science-based products that enhance the health of pets -- allowing owners the enjoyment of longer-lived, healthier companions.

Dr. Terry Beardsley established T-Cyte Therapeutics, Inc. to develop LTCI (Lymphocyte T-Cell Immunomodulator) to treat the devastating effects of FeLV and FIV viruses in cats. Until LTCI was granted a conditional license by the USDA, there were no approved, effective treatments of the disease or its symptoms: practitioners could only prescribe palliative care, isolation, and ultimately, euthanasia. Now, T-Cyte provides the only treatment aid for cats infected with FeLV and FIV and has expanded its treatment options to canines, with LTCI functioning as the first USDA-approved immune modulator for treatment of osteoarthritis in dogs.

¹ Yamada, et al., J. Rheumatol. 2011:38:1569
² Muir et al. Vet Surg., 2011:40:753