Adamis Pharmaceuticals Provides Update on Clinical Study Assessing Tempol for the Treatment of COVID-19
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) announced that the Data Safety Monitoring Board (DSMB) recommended continuing the Phase 2/3 clinical trial of Tempol for treating COVID-19 after a positive interim data review on March 11, 2022. The board found no need for modifications, which supports the trial's progress.
CEO Dr. Dennis J. Carlo expressed optimism about the trial's conduct and anticipates the next DSMB meeting in May.
- DSMB recommends continuation of the Phase 2/3 clinical trial without modifications.
- Interim analysis indicates favorable clinical and safety data for Tempol.
- None.
DSMB met to evaluate interim clinical and safety data and clears Phase 2/3 study to continue
SAN DIEGO, March 14, 2022 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today announced that on March 11, 2022, the Data Safety Monitoring Board (DSMB) overseeing the Phase 2/3 clinical trial investigating the use of Tempol for the treatment of COVID-19, met to evaluate the clinical and safety data from the first planned interim analysis. Following their evaluation, the DSMB recommended that the study continue without modification.
“We continue to be pleased with the conduct of the trial and look forward to the next DSMB meeting currently planned for May,” said Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals.
About the Phase 2/3 Clinical Trial
Additional information about the trial can be found on www.clinicaltrials.gov using the identifier NCT04729595.
Adamis has licensed exclusive worldwide rights under certain patents, patent applications and related know-how relating to Tempol for certain licensed fields including the treatment of respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19, and for the reduction of radiation-induced dermatitis in patients undergoing treatment for cancer.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The Company’s SYMJEPI® (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The Company’s ZIMHI™ (naloxone) Injection product is approved for the treatment of opioid overdose (https://www.zimhi.com/). Tempol is in development for the treatment of patients with COVID-19 and a Phase 2/3 clinical trial is underway. For additional information about Adamis Pharmaceuticals, please visit www.adamispharmaceuticals.com and follow us on Twitter and LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the following statements: statements concerning the Company’s Phase 2/3 clinical trial for Tempol; statements concerning the activities and process of the DSMB and the timing and outcome of that process; the Company’s beliefs concerning the mechanisms of action, safety and effectiveness of Tempol and that Tempol addresses an unmet medical need; the timing, progress or results of the Company’s Phase 2/3 clinical trial for Tempol or other studies or trials relating to Tempol; the opinions and beliefs of any third parties identified in this press release concerning the potential of Tempol as a treatment for COVID-19 and the results of previous studies of Tempol; the Company’s ability to commercialize the product candidates described in this press release, itself or through commercialization partners; the Company’s beliefs concerning the benefits, enforceability, and extent of intellectual property rights and protection afforded by patents and patent applications that it owns or has licensed, including those relating to Tempol; and other statements concerning the Company’s future operations and activities. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause Adamis’ actual results to be materially different from the results anticipated by such forward-looking statements. There are no assurances concerning the amount of time that the DSMB will take to conduct or complete the interim analyses and reviews described in this press release, concerning the results or outcome of that analysis, or concerning what decisions the Company will make after receiving information concerning that analysis. There can be no assurances regarding the timing, progress or outcome of trials or studies relating to Tempol, or that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication. In addition, as previously disclosed, each of the Company and its US Compounding Inc. subsidiary has received a subpoena from the U.S. Attorney’s Office for the Southern District of New York issued in connection with a criminal investigation. Accordingly, all forward-looking statements are subject to the outcome of this investigation and any other governmental investigations or proceedings. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, including its annual report on Form 10-K for the year ended December 31, 2020 and subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov.
Contact:
Adamis Investor Relations
Robert Uhl
Managing Director
ICR Westwicke
619.228.5886
robert.uhl@westwicke.com
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