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FDA Accelerated Review of Diffusion Pharmaceuticals Inc. TSC Clinical Development Plan

Wednesday, May 6, 2020  
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Diffusion Pharmaceuticals Inc. (“Diffusion” or “the Company”), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to deliver oxygen to the areas where it is needed most, today announced that the U.S. Food and Drug Administration (FDA) will accelerate its review of the Company’s clinical development plan using trans sodium crocetinate (TSC) in COVID-19 patients displaying severe respiratory symptoms and low oxygen levels. Development of Acute Respiratory Distress Syndrome (ARDS) is common in patients hospitalized with COVID-19 due to lack of sufficient oxygen to vital organs as a consequence of impedance in the lungs. Diffusion believes that TSC’s novel oxygen-enhancing mechanism of action could provide an important new treatment option for this life-threatening condition.

Under federal regulations, the FDA had up to 60 days from the Company’s April 24, 2020 submission to respond, but the FDA has announced its intention to significantly shorten review times for select COVID-19 submissions under its Coronavirus Treatment Acceleration Program (CTAP). Clinical trial preparations at multiple potential sites are continuing as the Company awaits the FDA’s expedited response.

Diffusion’s COVID-19 program is a cooperative research effort with the University of Virginia Health System (UVA) and the Integrated Translational Research Institute of Virginia (iTHRIV). To aid in timely trial enrollment, Diffusion is in discussions with institutions located in areas of severe COVID-19 incidence, both in the U.S. and in Eastern Europe. Similar to the FDA CTAP, health authorities in certain Eastern European countries have implemented emergency policies to compress regulatory review cycles from months to just days. These policies could expedite partnering possibilities with one or more Eastern European national institutes currently treating hundreds of COVID-19 patients daily, with almost immediate study start up and shortened time to data.

“This news of accelerated FDA review of the proposed clinical development plan for our lead compound TSC in a COVID-19 ARDS program is most welcome,” said David Kalergis, chief executive officer of Diffusion. “We continue to work with hospital and regulatory authorities in the U.S., and now also in Eastern Europe, to forge the fastest possible pathway to approval for TSC in the treatment of COVID-19 patients.”

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