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Be the first with the news that moves the market- Algernon Pharmaceuticals (AGN) has received positive feedback from the U.S. FDA for its investigation of NP-120 (Ifenprodil) to treat small cell lung cancer
- Algernon will immediately move to file an IND application to begin its Phase 1 SCLC study as soon as possible
- Algernon is planning to conduct its Phase 1 study in patients with recurrent SCLC to measure preliminary efficacy
- Algernon is also planning to file a Pre-IND meeting request for Ifenprodil and the investigation of pancreatic cancer in a Phase 1 study
- Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications
- Algernon Pharmaceuticals Inc. (AGN) opened trading at C$5.00 per share
Algernon Pharmaceuticals (AGN) has received positive feedback from the U.S. FDA for its investigation of NP-120 (Ifenprodil) to treat small cell lung cancer.
Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B).
CEO Chris Moreau sat down with Dave Jackson to discuss the news.
Algernon will immediately move to file an IND application to begin its Phase 1 SCLC study as soon as possible. Based on the feedback from the pre-IND (Investigational New Drug) meeting, the company plans to use its current Ifenprodil finished product inventory for the study. The U.S. FDA meeting also produced very helpful guidance on the protocol design and endpoints for the planned SCLC study.
Algernon is planning to conduct its Phase 1 study in patients with recurrent SCLC to measure preliminary efficacy.
The company also plans to apply for orphan drug designation for Ifenprodil to treat patients with SCLC. The U.S. Orphan Drug Act grants special status to a drug for the treatment, diagnosis or prevention of a rare disease or condition.
Algernon’s decision to investigate Ifenprodil and move it into human trials for SCLC is based on a preclinical study, authored by Dr. William North. In the study, Ifenprodil, in combination with chemotherapeutic agent Topotecan, produced clear additive effects that significantly blocked tumour growth.
In August 2021, Algernon announced that it had signed an exclusive licensing agreement with Dartmouth College to acquire the rights to a method of use patent for treating neuroendocrine cancers, which express functional NMDA receptors. Algernon appointed Dr. William North, professor emeritus at Dartmouth College and cancer research pioneer, as lead consultant.
Algernon is also planning to file a Pre-IND meeting request for Ifenprodil and the investigation of pancreatic cancer in a Phase 1 study.
“We are very pleased with the response we received from the U.S. FDA,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals Inc.
“Being able to move directly into a SCLC Phase 1 study will save the company considerable cost and time and will allow us to more quickly begin investigating Ifenprodil as a potential non-toxic cancer treatment option for patients who suffer from this disease.”
Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications.
Algernon Pharmaceuticals Inc. (AGN) opened trading at C$5.00 per share.
