Adamis Pharmaceuticals Doses First Patients in Phase 2/3 Clinical Trial for Tempol in the Treatment of COVID-19
Excerpt from the Press Release:
SAN DIEGO, Sept. 02, 2021 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today announced the initiation of patient dosing in the Phase 2/3 clinical trial for Tempol, an oral antiviral product candidate, in adult patients with confirmed COVID-19 infection. In preclinical studies, Tempol has been shown to have antiviral, anti-inflammatory and antioxidant activity. The trial is designed to enroll 248 patients.
Shyam Kottilil, MBBS, Ph.D., Professor of Medicine at the University of Maryland School of Medicine (UMSOM), Chief of the Division of Clinical Care and Research at UMSOM’s Institute of Human Virology, and Principal Investigator for the trial, commented: “The timing for this trial could not be more important as the delta variant spreads and breakthrough infections in vaccinated individuals occur in the U.S. and worldwide. Tempol as an oral antiviral and anti-inflammatory may be an important countermeasure if proven safe and effective in this trial.”
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis, commented: “We are pleased to begin patient dosing in this Phase 2/3 clinical trial for Tempol, which has demonstrated highly encouraging preclinical data in several disease models of infection and inflammation. Worldwide appearance of new variants with increased transmissibility and resistance necessitates the development of new therapeutic agents. The data from Israel should be a wake-up call to the U.S. and the rest of the world. Israel has among the highest levels of vaccination for COVID-19, yet the country is now showing one of the world’s highest infection rates (breakthrough). Currently, in Israel, the majority of the hospitalized patients are fully gene vaccinated. If approved, Tempol may not only prove to be a very important drug for the treatment of COVID-19, but it may also play a role in curbing the pandemic.”
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