The company has received written advice from the FDA regarding the regulatory approval path for its proprietary Cymerus™ mesenchymal stem cell (MSC) products in the U.S.
Cynata is developing cellular therapies to treat respiratory disease, cardiovascular disease and a number of other serious conditions.
The FDA confirmed that the scope and substance of Cynata’s “Chemistry, Manufacturing and Controls” dossier is commensurate with its expectations.
This indicates that Cymerus™ MSC products are expected to be of suitable quality for clinical trial use in the U.S.
Cynata also received clarification on the design of preclinical studies required to support a U.S. IND.
The company anticipates conducting those studies in parallel with the ongoing clinical trial of CYP-001 for the treatment of graft-versus-host disease (GvHD) being conducted in the UK and Australia.
The FDA also provided advice regarding the protocol for a planned GvHD clinical trial in the U.S.
Earlier this year, Cynata announced a strategic agreement with Fujifilm which included the Japanese company investing A$4 million in Cynata to become its largest shareholder.
The global regenerative medicine market was worth US$18.9 billion in 2016 and is expected to exceed US$53.7 billion by 2021.