CYT-108 / Cytonics Corp - LARVOL DELTA

Cytonics Announces that Last Patient Completes Last Visit in First-in-Human Phase 1 Clinical Trial for CYT-108 as a Treatment for Osteoarthritis (PRNewswire) - "Cytonics...announced that the last patient has completed their last visit in the Company's first-in-human clinical trial of CYT-108, a novel recombinant protein variant of an endogenous, broad-spectrum protease inhibitor, delivered twice (90 days apart) via intra-articular injection into arthritic knees....Topline results expected by end of Q2 2025....'With Phase 1 now complete, our team is focused on cleaning and locking the database, and preparing for submission of our IND to the FDA later this year'."

IND • P1 data • Trial status • Osteoarthritis

Cytonics Announces Launch of Regulation A+ Equity Crowdfunding Campaign to Fund Phase 2 Development (PRNewswire) - "Cytonics Seeks $24 million to pursue FDA Phase 2 Clinical Study of CYT-108, the Company's Novel Therapy for Osteoarthritis."

Commercial • New P2 trial • Osteoarthritis

Cytonics Announces Successful Completion of Phase 1 Study for First Nine Patients in CYT-108 Clinical Trial (PRNewswire) - "Cytonics Corporation...today announced that the first nine patients in its Phase 1 clinical trial evaluating CYT-108 as a therapy for osteoarthritis have successfully completed the study. All patients received two intra-articular doses of CYT-108, administered on Day 0 and Day 90, with follow-up extending to Day 180. Importantly, no drug-related adverse events have been reported, underscoring CYT-108's favorable safety profile."

Trial status • Osteoarthritis

Cytonics Announces Completion Of Enrollment For Phase 1 Clinical Study Evaluating CYT-108, A Novel Recombinant Protease Inhibitor, In Patients Suffering From Osteoarthritis Of The Knee (PRNewswire) - "Cytonics Corporation...today announced completion of enrollment for their Phase 1 clinical study of CYT-108, a recombinant variant of the alpha-2-macroglobulin blood serum protease inhibitor, as a putative disease-modifying therapy for osteoarthritis (OA)."

Enrollment closed • CNS Disorders • Osteoarthritis • Pain

Cytonics Announces Initiation Of First-In-Human Phase 1 Clinical Study For CYT-108 In Patients Suffering From Osteoarthritis Of The Knee (PRNewswire) - "Cytonics Corporation...today announced initiation of 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)....The Phase 1 study is designed to assess CYT-108's tolerability and efficacy in patients suffering from primary osteoarthritis 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."

New P1 trial • CNS Disorders • Osteoarthritis • Pain

Evaluation of CYT-108, a Recombinant Protease Inhibitor, for Treatment of Mild to Moderate Primary Osteoarthritis of the Knee (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: Cytonics Corporation | Initiation date: Mar 2024 ➔ Jun 2024

Trial initiation date • Immunology • Osteoarthritis • Pain • Rheumatology • ACAN

Evaluation of CYT-108, a Recombinant Protease Inhibitor, for Treatment of Mild to Moderate Primary Osteoarthritis of the Knee (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: Cytonics Corporation

New P1 trial • Immunology • Osteoarthritis • Pain • Rheumatology • ACAN