SAN DIEGO, Feb. 28, 2022 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today announced that due to accelerated patient enrollment in Tempol’s phase 2/3, double-blind, placebo-controlled trial of the COVID-19 remedy, an ad hoc meeting of the Data Safety Monitoring Board (DSMB) was held to compare clinical and interim protection knowledge of the trial. The DSMB is comprised of subject matter experts and can disseminate knowledge to discover the effects of the remedy on the topics of the trial. Based on an investigation of the data, the DSMB decided that the study can continue, as no clinical or protective considerations were identified. Data from the first 50 topics will be reviewed in March when the DSMB reviews them. more clinical and protective knowledge as a component of the first planned interim investigation.
“We are pleased with the progress of the trial, which has already exceeded the required number of subjects (124) for the time being, the planned interim DSMB analysis,” said Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals. ” After the first planned interim analysis, if the DSMB recommends continuation of the study, we will also report on when the DSMB review was planned after its completion, which may provide more data on protection and clinical outcomes at that time. hour.
The company previously announced the effects of a study published in collaboration with researchers at Stanford University, suggesting that Tempol has strong and extensive anti-cytokine activity in vitro. In addition, the company previously announced that in an animal form of SARS-COV2 provocation, a reduction in inflammation was observed in the lungs of animals that gained Tempol compared to control animals. In addition, independent researchers at the National Institutes of Health (NIH) recently noted that Tempol is a potential home-based antiviral. remedy for COVID-19 (https://covid19. nih. gov/news-and-stories/tempol-prospective-home-remedy-covid19).
Unlike two oral antivirals recently approved through an Emergency Use Authorization (EUA) for the treatment of COVID-19, Adamis Pharmaceuticals believes that Tempol addresses an unmet medical need due to its unique multiple mechanisms of action and well-tolerated protective profile demonstrated in previous preclinical studies. Studies.
About the Phase 2/3 Clinical Trial
Additional data on the trial can be found in www. clinicaltrials. gov identifier NCT04729595.
Adamis has authorized exclusive international rights to certain patents, patent programs, and Tempol-related technology for certain authorized areas, including the treatment of respiratory illness, asthma, respiratory syncytial virus, influenza, and COVID-19, and for radiation reduction. dermatitis induced in patients with cancer remedy.
About Adamis Farmacéutica
Adamis Pharmaceuticals Corporation is a specialized biopharmaceutical company primarily focused on the progression and commercialization of products in a variety of healing areas, including allergies, opioid overdoses, respiratory and inflammatory diseases. The company’s SYMJEPI® (epinephrine) injection products are FDA approved for use in the emergency remedy of acute allergic reactions, adding anaphylaxis. The company’s injectable product ZIMHI™ (naloxone) is approved for the opioid overdose remedy (https://www. zimhi. com/). Tempol is progressing for the remedy of COVID-19 patients and a phase 2/3 clinical trial is underway. To learn more about Adamis Pharmaceuticals, stop by www. adamispharmaceuticals. com and follow us on Twitter and LinkedIn.
Forward-Looking Statements
This press release comprises forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include explicit plans, anticipations, intentions, contingencies, long-term objectives, goals or progress and/or are not a different way s indeed ancient. These s relate to occasions or long-term effects of operations, including, among others, the following s: s related to the enrollment of patients in the Company’s Phase 2/3 clinical trial for Tempol; s in relation to the activities and procedure of the DSMB and the timing and effects of that procedure; the ideals of the Company regarding the mechanisms of action, defense and effectiveness of Tempol or of the other applicants of the Company’s products; the timing, progress or effects of the Company’s Phase 2/3 clinical trial for Tempol or other studies or trials related to Tempol; the reviews and ideals of known third parties in this press release regarding the prospect of Tempol as a remedy for COVID-19 and the effects of previous studies of Tempol; the Company’s ability to market the applicant products described in this press release, either by itself or through marketing partners; the Company’s ideals related to the benefits, enforceability, and scope of rights and coverage of high-level assets granted through the patents and patent programs it owns or has licensed, as well as those related to Tempol; and others related to the long-term operations and activities of the Company. These forecasts are only predictions and involve known and unknown hazards, uncertainties and other things, which could possibly cause the actual effects of Adamis to differ materially from the effects expected through such forecasts. There is no guarantee regarding the time that DSMB will take to perform or complete the interim analyzes and reviews described in this press release, regarding the final effects or results of such analysis, or regarding any decision that the Company will make. after having gained data relating to this analysis. There can be no promises regarding the timing, progress, or effects of trials or studies related to Tempol, or that Tempol will be found to be safe and effective in the treatment of COVID-19 or any other indication. Additionally, as previously reported, the Company and its subsidiary US Compounding Inc. obtained a subpoena from the United States Attorney’s Office for the Southern District of New York issued in connection with an investigation of criminals. Accordingly, all prospective emails are subject to the final results of this investigation and any other government investigation or proceeding. We cannot assess the impact of each thing on our business or the extent to which any one thing, or a combination of things, may also cause actual effects to differ materially from those contained in the future. yes You deserve not to place undue trust in forward-thinking people. Furthermore, any forward-looking statement speaks only as of the date it was made and, except as required by applicable law, we assume no legal responsibility to update or publicly disclose the effects of any revisions to such forward-looking statements. s forward-looking or to reflect occasions or occurrences after the date of this news release. Some of those dangers and additional perils, uncertainties and other things are described in greater detail in Adamis’s filings from time to time with the SEC, adding his Annual Report on Form 10-K for the fiscal year ended December 31. of 2020 and the next deposits. . with the SEC, which Adamis urges you to read and consider, all of which can be obtained free of charge at the SEC’s online page at http://www. sec. gov.
Contact:
Adamis Investor RelationsRobert UhlGeneral DirectorICR Westwicke 619. 228. 5886[email protected]
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