Cynata receives IRB approval for proposed phase 2 aGvHD clinical trial

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Cell therapy company Cynata Therapeutics (ASX:CYP) has received approval to commence the proposed phase 2 clinical trial in acute graft-versus-host disease (aGvHD).

The approval has been granted by Advarra, which is a US-based central Institutional Research Board (IRB) service provider.

IRB approval is an essential step in the process of opening clinical study sites and commencing a clinical trial in humans in the US.

The company said it is now finalising contractual and logistic arrangements with individual sites to prepare for patient recruitment.

The proposed clinical trial is a multicenter, randomised, double-blind, placebo-controlled phase 2 study that will investigate the efficacy and safety of CYP-001 in combination with corticosteroids, compared to corticosteroids alone, for the treatment of high-risk acute graft versus host disease.

The trial is expected to involve around 60 patients at sites in the US, Europe and Australia.

“We are very pleased with this important progress towards commencing a phase 2 clinical trial in this challenging condition," said Cynata chief medical officer Dr Jolanta Airey.

"This new study will build on the very promising results achieved in our phase 1 clinical trial of CYP-001 in which all safety and efficacy endpoints were met.

"In addition to this milestone IRB achievement in the USA, we are continuing to make similar progress in Europe and Australia and are expecting to commence patient recruitment in the coming few months. We aim to complete primary evaluation of the trial data in 2024.”