Algernon Pharmaceuticals Launches Pancreatic Cancer Clinical Research Program with Ifenprodil

Rhea-AI Summary

Algernon Pharmaceuticals has launched a clinical research program for pancreatic cancer (PC) using NP-120 (Ifenprodil), which showed a 50% reduction in tumor size in a murine model. The five-year survival rate for PC is a stark 7.9%, prompting the company to investigate Ifenprodil’s potential further, given its historical safety record. The company plans to submit a pre-IND meeting request to the U.S. FDA and seeks orphan designation and Fast Track status for Ifenprodil. The global pancreatic cancer treatment market is projected to reach USD 4.2 billion by 2025.

Positive

• Ifenprodil reduced average tumor size by approximately 50% in a pancreatic cancer animal model.
• The drug has a historical safety record over 45 years and has shown effectiveness in multiple diseases.
• Plans to file for orphan disease designation and Fast Track status with the U.S. FDA.

Negative

• Pancreatic cancer has a low survival rate, highlighting the critical need for effective treatments.

VANCOUVER, British Columbia, June 03, 2021 (GLOBE NEWSWIRE) -- 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.

Study Summary:

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.
  

        Study Link

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.

^{(1) https://pancreaticcanceraction.org/about-pancreatic-cancer/pancreatic-cancer-prognosis-and-survival/}

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.

FAQ

What are the results of Algernon Pharmaceuticals' study on Ifenprodil for pancreatic cancer?

The study demonstrated that Ifenprodil reduced average tumor size by approximately 50% in a pancreatic cancer animal model.

What is the significance of the five-year survival rate for pancreatic cancer?

The five-year survival rate for pancreatic cancer is only 7.9%, indicating a dire need for effective therapies.

What future steps is Algernon Pharmaceuticals taking for Ifenprodil?

The company is preparing a pre-IND meeting request with the U.S. FDA and seeks orphan disease designation and Fast Track status.

How is the global pancreatic cancer treatment market projected to grow?

The global pancreatic cancer treatment market is expected to reach USD 4.2 billion by 2025, driven by factors like aging population and awareness.

What is NP-120 (Ifenprodil) and its role in treating pancreatic cancer?

Ifenprodil is an NMDA receptor antagonist showing promise in reducing tumor size and impacting pancreatic cancer treatment.