Algernon Pharmaceuticals Inc announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on its investigation of NP-120 (Ifenprodil) for the treatment of small cell lung cancer (SCLC).
Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B).
The Vancouver, British Columbia-based company said that following the feedback, it is not planning to conduct any additional pre-clinical research and will immediately move to file an investigational new drug (IND) application to begin its Phase 1 SCLC study as soon as possible.
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Based on the feedback at the pre-IND meeting, Algernon plans to use its current Ifenprodil finished product inventory for the study. The FDA meeting also produced helpful guidance on the protocol design and endpoints for the planned SCLC study, the company said in the release.
“Being able to move directly into the 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,” Christopher J. Moreau CEO of Algernon said in a statement.
The company’s decision to investigate Ifenprodil and move it into human trials for SCLC is based on a preclinical study, authored by Dr. William North, and 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 significantly blocked tumor 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.
It also appointed Dr. William North, professor emeritus at Dartmouth College and cancer research pioneer, as lead consultant.
Algernon added that it 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 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.
Contact Ritika at ritika@proactiveinvestors.com