CYP-006TK Clinical Trial for Diabetic Foot Ulcers Completes Patient Recruitment

Cynata Therapeutics, an Australian biotech firm specializing in cell therapies, has successfully completed patient recruitment for its Phase 1 clinical trial of CYP-006TK, a treatment for diabetic foot ulcers (DFU). The trial involves 30 participants with DFU, who have been randomly assigned to either receive CYP-006TK for four weeks followed by standard care, or standard care alone, for the duration of the study. The patients will be monitored for 24 weeks post-treatment, with the final visit scheduled for September 2024. 

CYP-006TK is a novel wound dressing product derived from Cymerus™ iPSCs, which are induced pluripotent stem cells. These cells are cultured to produce mesenchymal stem cells (MSCs), which are then applied to a silicon-based dressing. DFU is a serious complication for diabetics, often leading to chronic wounds that are slow to heal and can result in severe pain, discomfort, and even amputation if not treated effectively. Initial results from the first 16 patients after a 10-week follow-up period have shown promising signs, with the CYP-006TK group experiencing an 87.6% median reduction in wound surface area, significantly higher than the 51.1% reduction observed in the control group. 

Dr. Jolanta Airey, Cynata's Chief Medical Officer, expressed gratitude to all involved and anticipation for the full study results. Cynata Therapeutics is known for its proprietary Cymerus™ platform technology, which utilizes iPSCs and mesenchymoangioblasts (MCA) to produce cell therapy products economically and at a commercial scale. 

The company's lead product, CYP-001, has shown positive safety and efficacy in treating steroid-resistant acute graft-versus-host disease (GvHD). Other ongoing trials for Cymerus products include Phase 2 for GvHD, Phase 3 for osteoarthritis, and DFU, with a renal transplant trial soon to start. The company's technology has also demonstrated potential in preclinical models for a range of diseases, such as critical limb ischemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, ARDS, and cytokine release syndrome. Cynata Therapeutics is listed on the Australian Securities Exchange under the code CYP and encourages investors to adopt a paperless registration process through Automic Group.

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