Cynata Therapeutics Ltd (ASX:CYP) has completed a successful meeting with Health Canada, regarding the clinical development of its proprietary Cymerus process in Canada.
Health Canada, the Canadian regulatory authority for national public health, agreed in principle that the unique Cymerus process meets its expectations for a product entering clinical trials.
The Cymerus process includes donor screening and testing, the induced pluripotent stem cell (iPSC) derivation process and the manufacture and testing of the final product.
Cymerus overcomes critical issues in the production of therapeutic mesenchymal stem cells (MSC) by enabling its economic manufacture in commercial-scale, independent of multi-donor limitations.
The company also received clarification from Health Canada on the design of preclinical studies required to support a clinical trial application in Canada.
This advice was consistent with the advice recently obtained from the U.S. FDA.
Earlier this year, Cynata entered into a strategic agreement with Fujifilm which included the Japanese company investing $4 million in Cynata to become its largest shareholder.
Cynata has already gained approval for its Phase 1 trial in patients with acute graft-versus-host disease (GvHD) in the UK and Australia.
The company is now continuing consultations with regulatory authorities in other key jurisdictions to ensure that there is a clear path for global clinical development of its products.