Cynata Receives Favourable Advice from UK Regulatory Authority •...

Cynata Receives Favourable Advice from UK Regulatory Authority

• Clear path to commence clinical program determined • World-first allogenic iPSC-derived mesenchymal stem cell product

• Initial clinical trial with Cymerus™ MSCs to take place in EU/Australia

• Ground-breaking trial on track to commence in second quarter 2016 Melbourne,
Australia;

28 January 2016: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), has received favourable advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA), following a successful scientific advice meeting, which took place earlier this month. The MHRA confirmed that Cynata’s proprietary Cymerus™ mesenchymal stem cell (MSC) product, CYP-001, is considered to be suitable for use in a proposed Phase 1 clinical trial in patients with graft versus host disease. Additionally, the MHRA advised that Cynata’s existing program of preclinical studies is expected to be sufficient to support the approval of the proposed clinical trial, and that no additional preclinical studies are required. The MHRA also agreed with the general design of the proposed clinical trial. On the basis of this advice, Cynata can now confirm that it intends to conduct the clinical trial at centres in the European Union, including the United Kingdom, and Australia. Additional countries in the EU will be confirmed following the completion of further interactions with the relevant regulatory authorities in those jurisdictions. The trial remains on track to commence during the second quarter of 2016. In parallel to these regulatory interactions, the process of identifying and selecting clinical centres for the study has been ongoing. A number of high profile investigators at leading institutions have expressed interest in participating in the study, and Cynata expects to formally select the investigators/centres by the end of the first quarter of this year. “We are delighted that one of the world’s most respected and experienced regulatory authorities has provided such a favourable assessment of the Cymerus™ technology. This reinforces the view that we had formed previously, that regulators in key jurisdictions are comfortable in principle with the progression of iPSC-derived therapies into human clinical trials”, said Dr Kilian Kelly, Cynata’s Vice President, Product Development. “We look forward to confirming the participating sites and proceeding with Clinical Trial Applications (CTA) for this ground-breaking clinical trial in the near future.”