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Cynata Files Application to Commence Phase 2 Clinical Trial in Critical Limb IschaemiaMELBOURNE, Australia, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), announced today that it has filed a Clinical Trial Authorisation application with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the proposed Phase 2 clinical trial of Cynata’s Cymerus™ mesenchymal stem cell (MSC) product CYP-002 in patients with critical limb ischaemia (CLI). CLI is an advanced stage of peripheral artery disease (PAD), which is a narrowing of arteries in the limbs, particularly the legs. CLI often results in amputation of the affected limb and is a major risk factor for cardiovascular events such as heart attack. The value of the global CLI treatment market has been forecasted to reach US$5.4 billion by 2025.1 Cynata anticipates conducting the clinical trial at multiple centres in the UK and Australia. The submission of the clinical trial application follows a successful scientific advice meeting that Cynata held with the MHRA earlier this year regarding this trial. The MHRA review process is expected to take up to 60 days. Dr Kilian Kelly, Cynata’s Chief Operating Officer, said, “CLI is an extremely serious condition and existing therapies have limited success. We are optimistic that CYP-002 may offer a valuable new treatment option. We look forward to the MHRA’s review of this important trial, and we aim to commence the recruitment of patients early in the coming year.” A preclinical study in a mouse mdel of CLI demonstrated that treatment with Cymerus MSCs led to significantly higher blood flow in the ischaemic limb versus placebo where blood flow remained low and resulted in limb loss.2
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, critical limb ischemia and osteoarthritis. In addition, Cynata has demonstrated utility of its Cymerus MSC technology in preclinical models of asthma, diabetic wounds, heart attack and cytokine release syndrome, a life-threatening condition stemming from cancer immunotherapy. About Critical Limb Ischaemia (CLI) 1 Zion Market Research report titled “Critical Limb Ischemia Treatment Market By Treatment (Devices and Medications): Global Industry Perspective, Comprehensive Analysis, and Forecast, 2018–2025” 2 https://doi.org/10.1016/j.jcyt.2015.10.013 3 https://doi.org/10.2147/VHRM.S209241 |