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FDA Grants Clearance to Amplia's IND for Pancreatic Cancer Trial in the United States

Thursday, January 18, 2024

Amplia Therapeutics Limited (ASX: ATX) is delighted to announce the approval of its Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for a trial involving the company's leading focal adhesion kinase (FAK) inhibitor, narmafotinib, in the treatment of pancreatic cancer. The upcoming trial aims to evaluate the safety, tolerability, and efficacy of combining narmafotinib with the widely used chemotherapy regimen FOLFIRINOX.

Currently engaged in a Phase 2a clinical trial of narmafotinib with gemcitabine and Abraxane® in advanced pancreatic patients in Australia and South Korea, the FDA's clearance now allows Amplia to explore the potential of narmafotinib in conjunction with FOLFIRINOX, a four-drug regimen extensively utilized in the United States for pancreatic cancer treatment.

The IND application underwent thorough review by the FDA, covering a comprehensive dossier featuring all preclinical and clinical data gathered for narmafotinib, as well as detailed Chemistry, Manufacturing, and Controls (CMC) information. The extensive document, spanning over 10,000 pages, reflects months of dedicated efforts by the company.

Dr. Chris Burns, CEO and MD of Amplia, emphasized the significance of the FDA's clearance, marking a pivotal step forward for the company. With the green light, Amplia is now set to plan the combination trial of narmafotinib with FOLFIRINOX in the United States. This strategic move expands the clinical possibilities for Amplia's top-tier FAK inhibitor, aligning with the preferred treatment approach for pancreatic patients in the USA and most of Europe. Dr. Burns highlighted the trial's relevance, positioning narmafotinib as a promising candidate to enhance the effectiveness of existing chemotherapy combinations in pancreatic cancer.



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