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Cynata Advances Toward Phase 2 Clinical Trial of Cymerus(TM) MSCs in Patients with OsteoarthritisMELBOURNE, Australia, Oct. 04, 2019 (GLOBE NEWSWIRE) -- Cynata Therapeutics Limited (ASX: CYP), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to provide an update on start-up activities of a Phase 2 clinical trial to evaluate Cynata’s Cymerus™ mesenchymal stem cells (MSCs) as a treatment for osteoarthritis, following the signing of an agreement with the University of Sydney. Key Highlights
Significant progress has been made with the University of Sydney for the Phase 2 study to be undertaken using Cynata’s Cymerus MSCs, and through a Research Support Agreement, Cynata’s commercial rights have been confirmed. Planning and start-up activities are now advancing rapidly. Dr Kilian Kelly, Cynata’s Vice President, Product Development, said: Clinical Trial Overview The trial will be led by Professor David Hunter, Florance and Cope Chair of Rheumatology, Chair of the Institute of Bone and Joint Research and Professor of Medicine at the University of Sydney, who has been a Chief Investigator of numerous clinical trials in osteoarthritis. He has more than 450 publications in high-impact journals, including the New England Journal of Medicine, Journal of the American Medical Association and British Medical Journal. As announced on 13 December 2018, the conduct of the clinical will be led by the University of Sydney and substantially funded by an Australian National Health and Medical Research Council (NHMRC) project grant, in addition to in-kind contributions from participating institutions and Cynata. Subject to obtaining relevant ethics and regulatory approvals, Cynata will manufacture and supply Cymerus MSCs for use in the trial. Under the agreement, full commercial rights to the use of the Cymerus MSCs in osteoarthritis are retained by Cynata. In the event that results of this Phase 2 trial are used to support regulatory marketing approval of Cymerus MSCs for the treatment of osteoarthritis, Cynata will potentially pay fees to the University of Sydney totaling up to AU$2.1 million, with the first payment (AUD $100,000) due when the Phase 2 data are used in a submission for marketing approval to a regulatory authority. Professor Hunter commented, “We look forward to working with Cynata on this important clinical trial. If Cymerus MSCs demonstrate an improvement in symptoms and knee joint structure in this trial, it will reduce osteoarthritis disease burden and have a substantial impact on osteoarthritis management worldwide.” About Osteoarthritis
About Cynata Therapeutics (ASX: CYP) Cynata’s lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Cynata plans to advance its Cymerus™ MSCs into Phase 2 trials for GvHD and critical limb ischemia. In addition, Cynata has demonstrated utility of its Cymerus MSC technology in preclinical models of asthma, critical limb ischemia, diabetic wounds, heart attack and cytokine release syndrome, a life-threatening condition stemming from cancer immunotherapy. ____________ |