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VANCOUVER, British Columbia, 16 July 2020 (GLOBE NEWSWIRE) – Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical-stage pharmaceutical progression company, is pleased to announce that it has concluded its clinical trial agreement with the Westchester Research Center of Westchester Hospital, Florida, for its multinational human phase 2b/3 in the NP-120 (Ifenprodil) for COVID-19. The principal investigator is Dr. Aimee Gonzalez, MD. Ifenprodil is an NMDA receptor antagonist that is particularly targeted at NMDA subunit 2B.
Corporate plans to make an introductory scale on-site at Westchester General Hospital the week of July 20, 2020 and the recruitment of patients on the test would possibly begin some time later.
The Company is in final contract negotiations with four more clinical sites in the United States. The company has already obtained moral approval from a central institutional review committee for all U.S. sites. The company is also in the final stages to conclude contract negotiations and obtain moral approval in Australia, Romania and the Philippines.
“Of the five U.S. institutes of study. With those we have worked, two are located in Florida, where they have recently had a significant number of cases shown from COVID-19,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “We look forward to running with Dr. Gonzalez and appreciate his paintings to launch the trial at Westchester General as soon as possible.
Context
The company announced on March 6, 2020 that it would explore Ifenprodil as an imaginable remedy for COVID-19 when it discovered an independent study showing that the drug was active in an animal style for H5N1, the world’s deadliest avian influenza, with a mortality rate of about 60% in humans. In the study, Ifenprodil reduced mortality by 40% and reduced acute lung damage and inflammation of lung tissue.
In addition to the company’s own animal knowledge of the relief of pulmonary fibrosis through ifenprodil in two separate studies, the company is reading ifenprodil to determine whether it can decrease the severity and duration of cOVID infection.
Summary of Phase 2b/3 Study Protocol
The company’s multinational phase 2b/3 human trial for COVID-19 is entitled “A randomized open phase 2b/3 examination on the protection and efficacy of NP-120 (Ifenprodil) for the remedy of hospitalized patients with confirmed COVID-19 disease. “
The trial will begin as a Phase 2b exam out of a total of 150 patients. With positive initial knowledge, the clinical trial will go directly to a phase 3 trial. Knowledge will be the number of patients expected to reach statistical significance in the phase 3 trial.
Patients will be randomized separately and will be treated with an existing popular treatment or a popular treatment plus Ifenprodil 60 mg (taken as a 20 mg 3 times daily pill) for one arm or a popular treatment plus Ifenprodil 120 mg (taken in the form of two 20 mg 3 times daily tablets) for two weeks.
During the period, doctors will see if there is an improvement in a number of secondary parameters, adding up mortality, blood oxygen levels, time spent on intensive care, and time spent on mechanical ventilation.
Test start date
The first patient is expected to register for Phase 2b/3 by the end of July 2020. It is difficult to assess at this time what the recruitment rate will be for all countries and decided sites. Once it begins, the Company will evaluate the board fee and provide a market update on an expected final touch date and the date on which knowledge is expected.
About NP-120 (Ifenprodil)
NP-120 (Ifenprodil) is an N-methyl-D-aspartate receptor antagonist (NMDA) that is particularly targeted at nmDA 2B subunit (Glu2NB). Ifenprodil prevents glutamate signaling. The NMDA receptor is discovered in many tissues, adding lung cells, T cells and neutrophils.
The company believes NP-120 may decrease infiltration of neutrophils and T cells into the lungs, where they can release glutamate and cytokines, respectively. The latter can cause the highly problematic cytokine typhoon which contributes to the loss of lung function and eventually death, as reported in patients inflamed by COVID-19.
About Algernon Pharmaceuticals Inc.
Algernon is a drug reuse company that studies and already approved medicines for new disease applications, successfully and effectively moving them to new human trials, presenting new formulations and seeking new regulatory approvals in global markets. Algernon, in particular, studies compounds that have never been approved in the United States or Europe to avoid discarding off-label prescriptions.
Algernon has introduced new global intellectual asset rights for NP-120 (Ifenprodil) for respiratory disease remedy and is running to expand an exclusive slow-release injectable formula.
CONTACT INFORMATION
Christopher J. Moreau Ceo of Algernon Pharmaceuticals Inc. 604.398.4175 701
[email protected] [email protected] www.algernonpharmaceuticals.com.
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NO inventory exchange has reviewed or accepted the duty of relevance or accuracy of the content of this press release. This press release includes forward-looking statements regarding product development, licensing, marketing, and compliance issues, and other statements that are not made in the old. Forward-looking statements are known through terms such as “will,” “possibly,” “should,” “anticipate,” “expects, ” and similar expressions. All statements other than statements of old fact, which are included in this press release, are forward-looking statements involving dangers and uncertainties. There is no guarantee that such statements will prove to be accurate and actual effects, and long-term occasions may also differ materially from those expected in those statements. The important points that may also cause the actual effects to differ materially from the Company’s expectations come with non-compliance with the terms of the exchange of securities or exchanges involved and other detailed hazards from time to time in the Company’s records with securities regulations. The reader is cautioned that the assumptions used in the preparation of any prospective data may be incorrect. The actual effects may differ materially from those expected due to a large number of known and unknown hazards, uncertainties and other points, many of which are beyond the Company’s control. Readers are cautioned not to place undue reliance on prospective data. These data, although considered moderate through control at the time of preparation, may be incorrect and the actual effects may differ materially from expected. The forward-looking statements contained in this press release are expressly qualified through this warning. The forward-looking statements contained in this press release are made as of the date of this press release and the Company will publicly update or revise any of the accompanying forward-looking statements, as expressly required by applicable law.