Diffusion Pharmaceuticals has announced that it expect delays in enrolment in the company’s ambulance-based PHAST-TSC phase 2 clinical trial in acute stroke due to the coronavirus. According to a news release, the LA County Fire Department informed the company that, due to the necessity to respond to the pandemic, it is suspending future training of first responders who had been scheduled to participate in the trial protocol. Such disruptions are expected to delay the company’s previously announced timeline for study completion.
“The coronavirus pandemic is affecting the conduct of clinical trials throughout the world, and the PHAST-TSC programme is no exception,” said Diffusion’s CEO, David Kalergis. “We are following the US Food and Drug Administration’s [FDA] recent guidelines for conducting clinical trials during this emergency, and are planning ways to make up lost time once the pandemic abates.”
Diffusion’s lead drug TSC was originally developed in conjunction with the Office of Naval Research, which was seeking a way to treat haemorrhagic shock caused by massive blood loss on the battlefield.
The company is currently enrolling patients in its PHAST-TSC phase 2 clinical trial in acute stroke. In July 2019 the Company reported favourable safety data in a 19-patient dose-escalation run-in study to its phase 3 INTACT programme, using TSC to target inoperable GBM. Further findings from the dose-escalation run-in study, released in December 2019, also showed possible signals of enhanced survival and patient performance.