Join our daily newsletter At The Bell to receive exclusive market insights
- Cynata Therapeutics (CYP) receives approval to launch a phase two clinical trial in acute graft-versus-host disease
- The clinical stage biotech company was granted the green light to undertake the trial from Advarra, a central institutional research board (IRB) service provider in the US
- IRB approval is considered an “essential step” in the process of opening clinical study sites and starting trials in humans in America
- Cynata expects the trial will be conducted in around 60 patients at sites across the US, Europe, and Australia
- Cynata Therapeutics last traded at 31 cents at 2:47 pm AEDT
Cynata Therapeutics (CYP) has received approval to launch a phase two clinical trial.
The clinical stage biotech company was granted the green light to commence a proposed phase two clinical trial in acute graft-versus-host disease (aGvHD) from Advarra, a central institutional research board (IRB) service provider in the US.
IRB approval is considered an “essential step” in the process of opening clinical study sites and starting trials in humans in America.
Cynata told investors it’s now finalising contractual and logistic arrangements with individual hospital sites ahead of patient recruitment.
This follows the clearance of Cynata’s investigational new drug (IND) application in 2022 and grant of orphan drug status for CYP-001.
The proposed clinical trial is expected to be conducted in around 60 patients at sites in the United States, Europe, and Australia.
“We are very pleased with this important progress towards commencing a phase two clinical trial in this challenging condition,” Cynata Chief Medical Officer Dr Jolanta Airey said.
“This new study will build on the very promising results achieved in our phase one clinical trial of CYP-001 in which all safety and efficacy endpoints were met.
“In addition to this milestone IRB achievement in the US, we are continuing to make similar progress in Europe and Australia and are expecting to commence patient recruitment in the coming few months.”
The company aims to complete initial evaluation of the trial data in 2024.
Cynata Therapeutics last traded at 31 cents at 2:47 pm AEDT.
