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AGN.C -- Coronavirus Treatment Spec; Phase 2 Clinical Trial news

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CSE:AGN   ALGERNON PHARMACEUTICALS INC.
Another CoronaVirus spec play. Pulled back from recent highs and trading in the support band, for now. I bought in at .20 - .21 today. $18M mkt cap. 90M float. Could see a nice run on today's news:

Algernon to Support Planned Phase 2 Trial of Ifenprodil for Coronavirus

VANCOUVER, British Columbia, March 19, 2020 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce that Novotech, a leading Asia-Pacific clinical research organization (CRO), has identified physicians in South Korea who have agreed to conduct an investigator initiated phase 2 clinical trial of Ifenprodil for coronavirus patients.

The investigators were identified after Algernon retained Novotech to conduct a feasibility study in South Korea. Novotech was asked to advise on the most efficient regulatory approach to initiating a phase 2 clinical trial for Ifenprodil for COVID-19 and to also help identify potential investigators.

Ifenprodil is an already approved drug in South Korea and Japan for certain neurological conditions with a known safety history. Algernon has been investigating Ifenprodil under its re-purposed drug program and has appointed Novotech as the lead CRO for its upcoming idiopathic pulmonary fibrosis (IPF) and chronic cough phase 2 clinical trial to be conducted in Australia.

The Company is in the process of refining the protocol for the phase 2 coronavirus study after receiving input from the investigators, and is working with Novotech to provide the necessary information and support in order to assist with the study’s approval. The study approval process may be expedited due to the current global health crisis.

The Company will release more information about the planned phase 2 coronavirus study shortly.

The decision to retain Novotech to conduct a feasibility study was made after a recent independent study found that Ifenprodil significantly reduced acute lung injury (ALI) and improved survivability in an animal study with Asian H5N1 infected mice by 40%. Asian H5N1 is the most lethal form of influenza known to date with an over 50% mortality rate. The drug was also previously shown in a separate study to prolong survival under anoxic (low oxygen) conditions, as might occur in patients with severely impaired lung function.

“This independent study data, along with the data generated from the Company’s animal studies on IPF and chronic cough, have supported the Company’s recent new COVID-19 and acute lung injury clinical program,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals.
Comment:
Some interesting activity on Friday with Industrial Alliance broker putting up walls while accumulating 500K+ shares over the course of 2 days.

More good news on Friday afternoon and I suspect there will be a followup soon on the FDA meeting requested by the company...

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VANCOUVER, British Columbia, March 20, 2020 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce today that it has chosen to appoint award winning Novotech as the contract research organization (“CRO”) for a planned physician initiated study of NP-120 (Ifenprodil) for COVID-19 infected patients in South Korea. Novotech is an internationally recognized full service CRO known for its experience across Australia, New Zealand, Asia and South Africa, representing emerging markets with a population base of over 3 billion people.

Novotech will be working to assist the investigators of the planned study, including supporting all aspects of the clinical trial. After the trial is approved, the Company will provide full details on the study protocol and timelines.

The Company also wishes to advise that it has retained Novotech to conduct a feasibility study in Australia for a phase 2 sponsor initiated Ifenprodil COVID-19 trial. Novotech has already identified 3 physicians who have indicated their interest to participate. The Company will update the market shortly.

“Novotech was a natural CRO choice for us to help to support this important investigator-led clinical trial,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals. “Since Ifenprodil is an already approved drug with a known safety history, we look forward to expedited steps that will make it available to patients as soon as possible under the study guidelines.”
Comment:
Algernon Appoints U.S. Company for cGMP Manufacturing of NP-120 (Ifenprodil) for COVID-19 Clinical Trials
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VANCOUVER, British Columbia, March 23, 2020 (GLOBE NEWSWIRE) -- VANCOUVER, BC – (March 23, 2020) – Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company announces that it has awarded the contract to manufacture the active pharmaceutical ingredient for NP-120 (Ifenprodil), to U.S. based Cascade Chemistry. Algernon has made the decision to scale-up cGMP manufacturing of Ifenprodil to support its quickly evolving clinical program for acute lung injury (ALI), its urgent clinical focus on COVID-19 (Coronavirus), as well as its idiopathic pulmonary fibrosis (IPF) clinical program. Cascade Chemistry, based in Eugene Oregon, are specialists in chemical synthesis.

As work begins on the synthesis of Ifenprodil, the Company will also be moving forward as soon as possible with toxicity testing, as well as the development of new formulations for parenteral injection for ALI and an oral slow release formulation for IPF.

“We are every pleased to have appointed Cascade Chemistry to start the synthesis of Ifenprodil,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “The Company believes strongly in the potential of Ifenprodil to treat patients who are suffering from a severe acute lung injury as a result of various forms of respiratory diseases including coronavirus, influenza, and IPF.
Trade closed: target reached

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