Algernon Pharmaceuticals Inc announced it has filed a pre-IND (Investigational New Drug) meeting request with the US Food and Drug Administration (FDA) for its Ifenprodil small cell lung cancer study.
The move marks the start of formal communications with the US regulatory body about the development of Algernon’s clinical research program and related license agreement with Dartmouth College.
In the application, Vancouver-based Algernon said it is confirming the direction it plans to take when it comes to developing Ifenprodil as an add-on to Topotecan to treat chemorefractory small cell lung cancer (SCLC).
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The disease represents 15% of all lung cancers and is considered to be highly aggressive, quickly spreading and metastasizing. While SCLC is usually very responsive to chemotherapy, it often recurs anywhere from five to 15 months following treatment.
Algernon said it decided to investigate Ifenrpodil as a possible SCLC treatment based on a January 2019 study that found Ifenprodil – in combination with Topotecan – helped to block tumor growth.
Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signaling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils and certain types of cancer cells.
“I am very pleased that our team has been able to advance our SCLC program so quickly with this pre-IND filing,” said Christopher Moreau, CEO of Algernon Pharmaceuticals, in a statement.
“People who are suffering from chemorefractory SCLC have very few options and so we are hoping to be able to move Ifenprodil directly into a US clinical trial as soon as possible.”
Algernon is a drug repurposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications.
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