VANCOUVER, British Columbia, June 03, 2021 — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) announces it has initiated a new clinical research program for pancreatic cancer (PC) and NP-120 (Ifenprodil). Ifenprodil demonstrated a significant anti-tumour effect in a PC animal model which was reported in a paper published in the Dove Press Journal, Clinical Pharmacology: Advances and Applications.
The research paper concluded that Ifenprodil significantly and rapidly reduced the average solid tumour size by approximately 50% by day three and remained stable while on treatment in a murine model of PC. The average tumour size in the untreated group doubled during the same period.
PC is an orphan disease and has a five-year survival rate of 7.9%. This means that only approximately 8 in 100 people will have survived for five years and beyond. The 10-year survival rate of the disease is 1%, meaning only approximately 1 in 100 people survive 10 years and beyond. PC has the lowest 5-year survival rate of any of the 22 common cancers.1
The Company has decided to expand its clinical investigation of Ifenprodil based on the drug’s significant effectiveness in treating a number of diseases including cancers, chronic disorders and psychological disorders such as addiction and PTSD, in certain pre-clinical and clinical studies. Algernon also recently announced that Ifenprodil, in its multi-national COVID-19 study, significantly reduced interleukin 6 (IL-6) at day five in the 20mg treatment arm, compared to the standard of care group. IL-6 is a pro-inflammatory cytokine and its involvement in multiple disease indications has been well established, including PC where its over-expression is related to poor survival.
Ifenprodil’s historical 45-year safety record, which was consistent with the findings of the Company’s 150 patient multi-national COVID-19 study, was also a contributing factor in the Company’s decision to proceed.
The Company has synthesized its own supply of Ifenprodil cGMP grade active pharmaceutical ingredient and has now begun the process of advancing to the finished product stage with new formulations planned.
Key findings from the study were as follows:
- Cell lines PanC-1, HPAC-1 and BXCPC-3 as well as tissue samples from a commercial array of insulinoma and adenocarcinoma with normal adjacent tissues showed GluN1 and GluN2B NMDA receptor subunit presence. Subunit presence on normal pancreatic tissues was not detected.
- Treatment of cell lines for 48 hours with Ifenprodil reduced viability across all trials in a dose-dependent fashion.
- Administration of 2.5mg/kg Ifenprodil once daily over 10 days reduced PanC-1 tumour xenograft size by almost half with the reduction persisting four days after treatment ceased (p<0.01) while having no apparent impact on animal health.
The Company has already begun preparing a pre-IND meeting request that will be filed shortly with the U.S. FDA to help determine next steps to advance Ifenprodil into clinical studies for PC. Algernon also plans to file for an orphan disease designation and seek Fast Track status, as well as a Breakthrough Therapy Designation.
“Ifenprodil’s anti-tumour effect in this study is very impressive when you consider it does not appear to have the serious side effects typically seen with other chemotherapy agents,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “Our business plan is to have upwards of three to four Phase 2 trials underway in 2022 and we are very pleased to be adding Ifenprodil with a cancer indication to our pipeline.”
Global Pancreatic Cancer Treatment Market
The global pancreatic cancer treatment market is expected to reach USD 4.2 billion in 2025, according to a new report by Grand View Research, Inc. Increasing tobacco consumption, smoking, obesity, and growing awareness pertaining to various treatment options available are propelling the market growth at a global level. The peak incidence of pancreatic cancer is seen in the age group of 65 to 75 years. This expanding geriatric population is also expected to drive the growth during the forecast period.
About NP-120 (Ifenprodil)
NP-120 (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 some cancer cells.
About Algernon Pharmaceuticals Inc.
Algernon is a drug re-purposing company that investigates well-tolerated, 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.
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