NOVEMBER 2, 2018
Jupiter, FL: Cytonics Corporation received feedback on the pre-clinical and clinical trial designs for their recombinant Alpha-2-Macroglobulin (A2M) drug product, Cyt-108. The FDA thoroughly reviewed Cytonics’ protocols over a 30 day period before providing guidance on the proposed toxicology, safety, and efficacy studies. Cytonics has commissioned an independent CRO to conduct a pilot study ahead of the pre-clinical trial to refine the study design. The company anticipates initiating pre-clinical trials by end of 2019.
“It is very important for us to stay in close communication with the FDA, and CBER in particular,Joey Bose
soensure that our pre-clinical and clinical studies are comprehensive enough to warrant IND submission. We intend to modify our study protocols to reflect the FDA’s suggestions. Fortunately, the fundamental methodology of the trial does not need to change, we just need to add some additional toxicology studies to confirm that Cyt-108 does not remain in the blood in high concentrations.”
President of Cytonics
Cytonics, founded in 2006, is a private research and development company focusing on molecular diagnostic and therapeutic products for chronic musculoskeletal diseases. The company developed the FACT diagnostic test which helps identify the source of back and joint pain and assists physicians in determining the most appropriate treatment. Cleared in January of 2014, Cytonics developed the Autologous Platelet-Integrated Concentrate (APIC) System as a platelet-rich-plasma (PRP) device. In addition, the company also developed autologous cell-free A2M
concentrate and other forms of A2M therapeutics, including optimized recombinant forms. The company is currently pursuing pre-clinical studies for their lead recombinant A2M candidate, Cyt-108.
658 W. Indiantown Rd. Suite 214
Jupiter, FL 33458