The U.S. Food and Drug Administration (FDA) has been working overtime to grant pre-investigational approvals for several vaccine and therapy candidates being designed to fight the COVID-19 disease caused by the novel coronavirus SARS-CoV-2. Diffusion Pharmaceuticals (NASDAQ: DFFN), a small biotechnology company from Charlottesville, Va., is one of the latest companies to hit its stride with a COVID-19 therapy candidate.
8-K findings
According to the company's most recent 8-K filing with the U.S. Securities and Exchange Commission (SEC), Diffusion has received an accelerated response from the FDA regarding its pre-investigational new drug (PIND) application.
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The company filed its application April 27 by seeking guidance from the FDA on how to follow through with its proposed clinical trial program for a COVID-19 treatment using trans sodium crocetinate (TSC) for patients who have displayed respiratory symptoms and low oxygen levels.
Diffusion noted in the 8-K that the FDA had suggested a double-blind, controlled, and randomized design for a clinical trial. Because the COVID-19 situation has developed so fast (and continues to do so), such a trial will give needed context on the way it affects the population. Additionally, the agency recommended that Gilead Sciences's (GILD -0.51%) remdesivir, which has been approved for emergency use, be a component of the trial.Preclinical data indicate that TSC could work to fight COVID-19 by increasing oxygen availability.
New ranges for clinicals and finances
The accelerated response to Diffusion's PIND application also allows the company to conduct domestic U.S. trials, and it allows for a collaborative initiative with the Romanian National Institute of Infectious Diseases to cover European tests of TSC and its use in COVID-19 treatment.
Diffusion Pharmaceuticals has traded for well under $2.50 for several weeks. The stock's volatility makes it a strong contender for those seeking substantial returns in the future -- as long as they're comfortable with today's risks. Diffusion's capital has seen an uptrend in recent months, including a building momentum behind it, which includes the TSC clinical trial news and a $12 million offering closure where share prices were averaged out over about $1.05.
This windfall could offer Diffusion on-hand cash that could finance more clinical trials and buoy other ventures that may include more trials to counter COVID-19.
What's TSC and its origins?
According to Diffusion Pharmaceuticals, TSC is a patent-protected mechanism which offers safely reoxygenated tissue. Reportedly, a trans sodium crocetinate platform could be used to enhance the power of radiation and chemotherapy treatments for several cancers.
TSC oxygenates hypoxic tissues that use the effects of water molecules in blood plasma through increasing hydrogen bonding between the said water molecules. The origins of TSC were developed by Diffusion and the U.S. Office of Naval Research. The Navy was working toward a way to treat organ failure and mortality caused by low oxygen levels from blood loss in battlefield settings.
TSC includes treatment for organ failure caused by respiratory damage, like the damage brought on by COVID-19, and other cases from stroke and brain cancer.
