Diffusion Pharmaceuticals ([[DFFN]] -9.3%) submits Clinical Trial Application to the Romanian National Agency for Medicines and Medical Devices ((NAMMD)) to initiate a Phase 1a/1b clinical trial of the Company's oxygenation-enhancing product candidate trans sodium crocetinate ((TSC)) for the treatment of hospitalized COVID-19 patients displaying severe respiratory symptoms and low oxygen levels. Diffusion...
Low oxygen levels occur as a consequence of damage to the lungs from COVID-19 and often result in mechanical ventilation and, if that is ineffective, multiple organ failure – the leading cause of death in COVID-19 patients. Assuming NAMMD authorization of the CTA and approval by the National ethics committee under NAMMD’s accelerated seven-working-day approval process, Diffusion plans to begin the 24 patient Phase 1a portion of the clinical trial by the end of Q2 2020.
The Company had previously been notified by Nasdaq on December 11, 2019 that it was not in compliance with the minimum bid price rule because its common stock failed to maintain a minimum bid price of $1.00 for 30 consecutive business days. In order to regain compliance with Listing Rule 5550(a)(2), the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved on May 28, 2020. The Company’s last closing bid price on May 28 was $1.27.
The PIND was filed on April 27, seeking FDA guidance on the Company’s proposed clinical development program for the use of trans sodium crocetinate (TSC) in COVID-19 patients displaying severe respiratory symptoms and low oxygen levels. The FDA’s accelerated response to the PIND meeting request recommended that the first U.S. TSC COVID-19 study employ a double-blinded, controlled, randomized clinical trial design to address the wide variability in standard of care due to the rapidly evolving COVID-19 experience.