CapGenesis Announces Start Of Dosing In An Exploratory Study Of CGS-125 For Management Of Osteoarthritic Knee Pain

BETHESDA, MD--(Marketwired - November 23, 2015) - CapGenesis Therapeutics, a developer of topical pharmaceutical and consumer healthcare products for site-specific pain, therapeutic dermatologics and orphan disorders, today announced the dosing of the first patient in a randomized, double-blind exploratory study of topical CGS-125 compared with placebo for treatment of subjects with osteoarthritic knee pain.

Osteoarthritis (OA) is a degenerative joint disease involving the cartilage and many of its surrounding tissues. According to Datamonitor, approximately 36 million people in the U.S. and approximately 40 million people in the E.U. will be affected by OA by 2021. Osteoarthritis is the third most common diagnosis made by primary care physicians in older patients and is the most common condition involving the knee. Significant knee pain affects about one quarter of the population that is 55 or older, and half of these individuals have radiographic evidence of osteoarthritis, while a quarter of these individuals have some degree of disability.

CGS-125 is a novel, high-strength topical formulation of trans-capsaicin, a known agonist of the TRPV-1 channel, which defunctionalizes nerve fibers that transmit pain signals to the brain. Prolonged exposure to capsaicin has been shown to reduce TRPV-1 activity resulting in sustained pain relief. CGS-125 is a proprietary formulation combining varying concentrations of capsaicin with additional active ingredients to more effectively reduce joint pain and improve mobility, while diminishing the burning sensation typically associated with application of capsaicin products.

The study will be conducted in approximately 48 subjects diagnosed with OA of both knees according to the 1986 American College of Rheumatology (ACR) criteria. Objectives of the study include evaluations of safety, tolerability, and potential clinical activity of CGS-125. This exploratory study is being conducted at a single site in the Dominican Republic under the supervision of an Institutional Review Board (IRB) and the National Council on Bioethics in Health (CONABIOS), which functions as a Dominican national IRB.

Previous studies of CGS-125 in more than 20 OA patients were conducted under a local IRB and CONABIOS approval at a single site in the Dominican Republic. Topical application of CGS-125 for 4 consecutive days resulted in the functional elimination of OA knee pain and increased joint mobility during the course of treatment. Additionally, follow up interviews with subjects who completed the course of treatment suggest that relief of OA knee pain lasted for 30 days or more, with the duration of the effect appearing to be dose dependent on the strength of capsaicin in the treatment. In this earlier study CGS-125 was well tolerated and no local anesthetic was required, compared to most TRPV-1 agonists.

Stanley Pillemer, M.D., Chief Medical Officer of CapGenesis, stated, "We are excited to further assess CGS-125's ability to provide lasting relief from OA knee pain with the potential to improve function in these patients. Our goal is to bring CGS-125 to the market as a novel treatment for this condition that could significantly decrease chronic pain associated with OA."

About CapGenesis Therapeutics
CapGenesis Therapeutics is dedicated to improving the quality of life through developing topical pharmaceutical and consumer healthcare products for site-specific pain, therapeutic dermatologics and orphan disorders. CapGenesis' proprietary pipeline is based on novel formulations of proven, active compounds to enhance efficacy and reduce side effects. The Company's lead program, CGS-125 is in an exploratory study for osteoarthritic knee pain. To learn more about CapGenesis Therapeutics please visit the Company's website at http://www.capgenesis.com/.