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Cytonics Announces That Its Recombinant A2M Variants Attenuate Cartilage Degeneration in OA Models

/ -- JUPITER, FL--(Marketwired - June 21, 2016) - Cytonics Corporation, the originator and developer of systems to treat orthopedic and other therapeutic Alpha-2-Macroglobulin (A2M) for applications, announced that its new recombinant versions of A2M demonstrated enhanced attenuation of cartilage degeneration during OA development in ex vivo and in traditional in vivo rat Anterior Cruciate Ligament Transection (ACLT) OA model when compared to wild type A2M and saline control. It also exhibited evidence of cartilage regrowth.

In 2014, a peer-reviewed paper from Dr. Wei's group at Brown independently validated A2M as an effective treatment for post-traumatic osteoarthritis by inhibiting catabolic enzymes. Now, the team from Brown University has collaborated with Cytonics scientists to demonstrate that Cytonics' new, targeted recombinant A2M variants outperform wild type A2M.

"In addition to showing enhanced function in the rat ACLT model, A2M variants inhibited cartilage catabolism by up to 200% compared to wild type -A2M. Our histological, immunohistochemistry, ELISA, and RT-PCR data further demonstrated that supplemental A2M and its variants not only attenuate cartilage damage but also enhance cartilage matrix Col 2 and aggrecan synthesis," said Dr. Lei Wei, chief investigator.

Gaetano Scuderi, MD, Founder and CEO of Cytonics, said, "Through years of research and development, Cytonics steadily created an understanding of the important therapeutic role of A2M, filed numerous patents on its use and methods of clinically relevant concentration, and has developed and launched systems to concentrate autologous A2M for orthopedic and other uses. Our APIC system was cleared by the FDA in 2014 and has created great interest in the orthopedic community. While many autologous substances are being injected into the OA knee in the hopes of improving the pain and disability associated with OA, only the Cytonics APIC system has an FDA-approved Investigational New Drug (IND) application to scientifically prove its effectiveness in mild to moderate osteoarthritis (OA) in the knee. We have recently concluded enrollment of a Phase 2 study."

"Our autologous A2M is an exciting and effective treatment," said Dr. Scuderi, "but many clinicians' offices will not take on the time, expense and safety concern of drawing blood and preparing autologous concentrates of bone marrow, PRP or even A2M. An optimized recombinant, off-the-shelf variant will eliminate these drawbacks and become the OA treatment of choice."

Cytonics is a private research and development firm in Jupiter, Florida developing molecular diagnostic and therapeutic products for chronic orthopedic and other diseases. Its initial product, Autologous Platelet-Integrated Concentrate, (APIC) System was 510(k) cleared in 2014. Its novel APIC -CF system concentrates A2M from a patient's own blood for direct injection into a joint that shows signs of OA. The system is expected to be the first treatment for OA that can inhibit well known causes of cartilage breakdown and thereby prevent cartilage loss, reduce pain, and stop the progression of OA, as demonstrated by the company's and other's independent research.

Cytonics Corporation