Adamis Pharmaceuticals Announces Pre-IND Feedback from FDA Enabling Advancement of Tempol, a Novel Anti-Inflammatory and Anti-Oxidant Drug for the Treatment of COVID-19
Excerpt from the Press Release:
SAN DIEGO, Aug. 14, 2020 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today that in response to Adamis’ Pre-Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA), the FDA has provided detailed comments regarding the prospective use of Tempol in a randomized placebo controlled trial. The FDA’s response now allows Adamis to proceed to the next step of formally submitting an IND for Tempol, and at the same time, begin formal applications for funding to governmental agencies to support the clinical trial and large-scale manufacturing.
Dr. Dennis J. Carlo, President and CEO of Adamis stated: “After submitting an extensive clinical protocol entitled ‘Preventing COVID-19 Related Hospitalizations in Subjects with COVID-19 Infection’, we received thoughtful and comprehensive guidance from the FDA. We believe that Tempol’s unique antioxidant and anti-inflammatory activity, and its ability to inhibit the “cytokine storm” in pertinent animal models, makes it a strong candidate for the potential treatment of COVID-19. By protecting healthy cells, Tempol may delay or prevent disease progression and hospitialization.”
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