Australian stem cell and regenerative medicine company, Cynata Therapeutics, (ASX: CYP), has filed a Clinical Trial Authorisation application for its lead Cymerus mesenchymal stem cell (MSC) product, with the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The company said its proposed Phase 1 study will be conducted in patients with graft-versus-host disease (GvHD), a potentially fatal disease that often follows a bone marrow transplant procedure and occurs when the immune cells in the donor material (the graft) attack the recipient’s tissues (the host) as “foreign”.
Bone marrow transplants are used in the treatment of certain cancers including leukaemia. The application to the MHRA follows a successful scientific advice meeting which took place earlier this year.
“The application to commence our Phase 1 study with the MHRA represents the culmination of an intensive program of manufacturing process development, safety evaluation and proof-of-concept studies. The successful outcomes from our product development activities over the past two-and-ahalf years have allowed us to move things forward,” said Cynata Vice President of Product Development, Dr Kilian Kelly. “We have been very pleased with the result of our pre-clinical program and are eager to advance to an initial clinical study with our induced pluripotent stem cell (iPSC) derived MSC therapeutic product, CYP-001.”