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Cytonics commenced enrollment for its Phase 1 clinical study of CYT-108, a recombinant variant of the alpha-2-macroglobulin blood serum protein, targeting proteases responsible for cartilage degradation in osteoarthritis (OA). CYT-108 was engineered for increased protease-inhibition activity against the major classes of proteases that are responsible for the majority of cartilage catabolism in arthritic joints, while maintaining its broad-spectrum anti-protease activity against serine and threonine proteases.
The Phase 1 study is designed to assess CYT-108’s tolerability and efficacy in patients suffering from primary OA of the knee. A single dose of the drug will be administered intra-articularly at two timepoints, 90 days apart. Patients will be monitored every few weeks for an additional 90 days to evaluate safety, pharmacokinetics, and efficacy in reducing joint pain, stiffness, and mobility limitations.
“Our first-in-human clinical trial is the culmination of 6 years of preclinical R&D, during which we overcame many technical challenges in developing our recombinant A2M variant, CYT-108,” said Joey Bose, President & CEO of Cytonics. “The massive size of the engineered protein (720kD) and complex folding structure made GMP production a scientific feat, and the ingenuity and experience of Lewis Hanna, PhD, our Chief Scientific Officer allowed us to surmount this technical challenge. The preclinical data demonstrates signs of CYT-108’s protective capabilities not only in the cartilage tissue, but in multiple other joint physiologies that are involved in the pathogenesis of osteoarthritis. Furthermore, we believe that the development of CYT-108 is de-risked by the clinical and commercial success of our first-generation OA therapy, the Autologous Protease Inhibitor Concentrate medical device, which has treated over 8,000 patients using autologous A2M selectively concentrated from their own blood.”
Source: Cytonics Corp.
Cytonics commenced enrollment for its Phase 1 clinical study of CYT-108, a recombinant variant of the alpha-2-macroglobulin blood serum protein, targeting proteases responsible for cartilage degradation in osteoarthritis (OA). CYT-108 was engineered for increased protease-inhibition activity against the major classes of proteases that are...
Cytonics commenced enrollment for its Phase 1 clinical study of CYT-108, a recombinant variant of the alpha-2-macroglobulin blood serum protein, targeting proteases responsible for cartilage degradation in osteoarthritis (OA). CYT-108 was engineered for increased protease-inhibition activity against the major classes of proteases that are responsible for the majority of cartilage catabolism in arthritic joints, while maintaining its broad-spectrum anti-protease activity against serine and threonine proteases.
The Phase 1 study is designed to assess CYT-108’s tolerability and efficacy in patients suffering from primary OA of the knee. A single dose of the drug will be administered intra-articularly at two timepoints, 90 days apart. Patients will be monitored every few weeks for an additional 90 days to evaluate safety, pharmacokinetics, and efficacy in reducing joint pain, stiffness, and mobility limitations.
“Our first-in-human clinical trial is the culmination of 6 years of preclinical R&D, during which we overcame many technical challenges in developing our recombinant A2M variant, CYT-108,” said Joey Bose, President & CEO of Cytonics. “The massive size of the engineered protein (720kD) and complex folding structure made GMP production a scientific feat, and the ingenuity and experience of Lewis Hanna, PhD, our Chief Scientific Officer allowed us to surmount this technical challenge. The preclinical data demonstrates signs of CYT-108’s protective capabilities not only in the cartilage tissue, but in multiple other joint physiologies that are involved in the pathogenesis of osteoarthritis. Furthermore, we believe that the development of CYT-108 is de-risked by the clinical and commercial success of our first-generation OA therapy, the Autologous Protease Inhibitor Concentrate medical device, which has treated over 8,000 patients using autologous A2M selectively concentrated from their own blood.”
Source: Cytonics Corp.
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
