Enrolling First Patient in A2M Therapy Study

Cytonics Starts FDA Arthritis Trial, Enrolling First Patient in A2M Therapy Study 

June 15, 2015 (Jupiter, FL): Cytonics Corporation, a biotechnology company focused on developing therapeutics for musculoskeletal diseases based on Alpha-2-Macroglobulin (A2M), announces the treatment of the first patient in the phase I/II clinical trial of the APIC-CF System for the treatment of mild to moderate osteoarthritis (OA).

Cytonics APIC-CF System is indicated for the treatment of joint pain due to cartilage degeneration, osteoarthritis, inflammation, and meniscal degeneration. The APIC-CF System concentrates the protease inhibitor Alpha-2-Macroglobulin (A2M) from a patient’s own blood for direct injection into a joint for the treatment of mild to moderate osteoarthritis. A2M is a broad spectrum protease inhibitor which effectively inhibits the proteases associated with cartilage degeneration and OA. Furthermore, A2M protects cartilage from proteases that contribute to the upregulation of inflammatory mediators involved in osteoarthritis (OA).

The APIC-CF trial is a multicenter, double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of the APIC-CF supplemental injection of concentrated Alpha-2-Macroglobulin (A2M). Cytonics has done extensive research in A2M therapy for musculoskeletal disease. The APIC-CF trial will evaluate both a low dose and a high dose vs. placebo and include over 300 patients at approximately 15 clinical sites throughout the United States.

“We are excited to have entered the clinical stage of our APIC-CF System. Our team eagerly anticipates outcomes and recognizes the massive potential this breakthrough molecular therapeutic presents to the orthopedic market”, said Gaetano Scuderi, MD, President and Founder of Cytonics Corporation. “We are confident in A2m treatment based upon our extensive history of studying cartilage disease and pain. We have extensive patent protection on A2M therapy as well.“

“A2M is expected to be the first treatment that addresses the biochemical progression of Osteoarthritis (OA) by inhibiting the dynamic protease activity causing cartilage breakdown as well as stopping the pain from FAC production, a pathway which we elucidated ”, said Dr. Scuderi.

In addition to the extensive research conducted by Cytonics, Wang et. al demonstrated that A2M supplementation may “inhibit OA cartilage in vivo by decreasing cartilage catabolic and inflammatory factors, in addition to inhibiting protease activity.”1 The results of this milestone study independently corroborated that supplemental intra-articular A2M inhibits OA cartilage breakdown, decreases cartilage catabolic and inflammatory factors, and inhibits protease activity. Additionally, it is noted that early intervention may be critical for preventing or minimizing the development of Post Traumatic Osteoarthritis (OA).

“Cytonics research on A2M is a significant advancement in the understanding of Osteoarthritis (OA), and presents a promising new therapeutic that may be the key to stopping OA at the molecular level,” says Dr. Pasquale Montesano, Board Certified Orthopedic Surgeon.

To learn more about the APIC-CF trial, visit www.Cytonics.com. Additional details can also be found online at https://clinicaltrials.gov/ct2/show/NCT02210468.

1Wang, S., Wei, X., Zhou, J., Zhang, J., et. al. “Identification of α2-Macroglobulin as a Master Inhibitor of Cartilage-Degrading Factors that Attenuates the Progression of Posttraumatic Osteoarthritis.” Arthritis & Rheumatology 66.7 (2014): 1843-1853.