FDA Approves Start of Innovative On-Ambulance Phase 2 Clinical Trial for Treatment of Acute Stroke by Diffusion Pharmaceuticals

Diffusion Pharmaceuticals (Nasdaq:DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it’s needed most, announced today that it has received FDA approval to enroll patients in an ambulance-based Phase 2 clinical trial testing its lead drug, trans sodium crocetinate (TSC), for the treatment of acute stroke.

As quoted in the press release:

The trial, named PHAST-TSC (Pre-Hospital Ambulance Stroke Trial-TSC), will involve 23 hospitals across urban, suburban, and rural areas in Los Angeles and Central Virginia, working closely with approximately 150 emergency medical transport groups. Results for the PHAST-TSC trial could be available in just under two years – a critically fast turnaround for this potential improvement in the front-line medical treatment of stroke, which afflicts nearly 800,000 Americans each year at an estimated cost of over $34 billion to the U.S. economy.

Nearly two million brain cells die each minute during a stroke. As a result, medical providers seek to provide treatment for patients as quickly as possible during the hours immediately after stroke onset. TSC, which will be administered by paramedics while the stroke victim is still in the ambulance, may offer new hope for these patients by increasing the amount of oxygen directed to affected tissue, potentially reducing cell death and improving patient outcomes. In addition to stroke, TSC has shown safety and efficacy to date in oncology, with a Phase 3 trial in glioblastoma (GBM) brain cancer currently enrolling.

Click here to read the full press release.