Algernon Pharmaceuticals Files U.S. FDA Pre-IND Meeting Request for Ifenprodil Small Cell Lung Cancer Study

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VANCOUVER, British Columbia, Sept. 22, 2021 (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 it has filed a pre-IND (Investigational New Drug) meeting request with the U.S. Food and Drug Administration (U.S. FDA) for its investigation of NP-120 (Ifenprodil) for the treatment of small cell lung cancer (SCLC).

This initiates formal communications with the U.S. FDA regarding development of the Company’s newly announced SCLC clinical research program and related license agreement with Dartmouth College.

In the pre-IND meeting request application, the Company is confirming the direction it plans to take in the development of Ifenprodil as an adjunct to Topotecan for the treatment of chemo refractory SCLC.

SCLC represents 15 percent of all lung cancers and occurs almost exclusively in smokers. It is distinguished from non-small cell lung cancer by its rapid doubling time, high growth fraction, and the early development of widespread metastases. Although considered highly responsive to chemotherapy and radiotherapy, SCLC usually recurs within 14 to 15 months for patients with limited-stage SCLC and five to six months for patients with extensive-stage SCLC. Many of these patients are candidates for additional systemic treatment. The median survival of patients with relapsed SCLC ranges from two to six months. 1

The Company’s decision to investigate Ifenprodil and move it into human trials for SCLC is based on a study published in January 2019, entitled “Small-Cell Lung Cancer Growth Inhibition: Synergism Between NMDA Receptor Blockade and Chemotherapy”. In the study, Ifenprodil in combination with chemotherapeutic agent Topotecan, produced clear additive effects that completely blocked tumor growth.

Study Link: Small Cell Study

“I am very pleased that our team has been able to advance our SCLC program so quickly with this pre-IND filing,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals Inc. “People who are suffering from chemo refractory SCLC have very few options and so we are hoping to be able to move Ifenprodil directly into a U.S. clinical trial as soon as possible.”

About Ifenprodil

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils and certain types of cancer cells.

About Algernon Pharmaceuticals Inc.

Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

1 https://www.uptodate.com/contents/treatment-of-refractory-and-relapsed-small-cell-lung-cancer#!

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.


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