Cynata Prepares for Phase 1 Clinical Trial

Company News

Australian stem cell and regenerative medicine company, Cynata Therapeutics (ASX:CYP), announced that it intends to file an application for regulatory approval with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a Phase 1 clinical trial of CYP-001 in July 2016.

Cynata’s Phase 1 clinical trial application process advanced after a successful scientific advice meeting with the MHRA earlier this year.

CYP-001 is Cynata’s lead Cymerus mesenchymal stem cell (MSC) product and the Phase 1 trial will be conducted in patients with steroid-resistant graft-versus-host disease (GvHD).

The company said it is currently preparing its clinical trial application and expects to receive additional data within the coming weeks from the proof of concept (PoC) study of CYP-001 progressing at the University of Massachusetts Amherst (UMass).

This PoC study is assessing the response to CYP- 001 in animals with an experimental form of severe GvHD. Interim data announced in April demonstrated that CYP-001 treatment resulted in a strong, statistically significant, survival benefit in the study animals and confirmed biological activity of the Cymerus MSC product.

The additional data for the MHRA application process is expected to provide a more robust data package for clinical trial approval.

“The pre-clinical product development program has been a success, with considerable credit due to Dr Kilian Kelly, Cynata’s VP of Product Development,” said Cynata CEO and Managing Director Dr Ross Macdonald.

“We are on track with our plans to file the clinical trial application in the UK and with that, the Company is approaching a very important, value accretive milestone in the development of Cynata's unique and proprietary MSC technology, Cymerus”.