Posted: 19 January 2024
Amplia Therapeutics Limited is pleased to announce that the US FDA have cleared Amplia’s IND application for a trial of Amplia’s best-in-class focal adhesion kinase (FAK) inhibitor narmafotinib in pancreatic cancer. The proposal trial will explore the saferty, tolerability and efficiency of a combination of narmafotinib with the chemotherapy regime FOLFIRINOX.
The company is currently undertaking a Phase 2a clinical trial of narmafotinib, in combination with two chemotherapy drugs, gemicitabine and Abraxane, in advanced pancreatic patients in Australia and South Korea. In contrast, the IND application reviewed by the US Food and Drug Administration (FDA) supports the use of narmafotinib in combination with a different chemotherapy called FOLFIRINOX (a four drug regimen), which is widely employed in the US for the treatment of pancreatic cancer.
The IND document is an extensive dossier that details all preclinical and clinical data amassed to date for narmfotinib, along with the complete CMC (chemistry, manufacturing and controls) information. The final document comprised more that 10,000 pages and represented a major undertaking by the company over the previous months.
Amplia CEO and MD Dr Chris Burns comments: “Clearance of the IND by the US FDA is a significant step forward for the Company. We will now start planning the combination trial of narmofitinib with FOLFIRINOX in the US, which expands the clinical opportunities for our best-in-class FAK inhibitor. FOLFIRINOX is the preferred treatment for pancreatic patients in the USA and most of Europe, and therefore this combination trial is highly relevant as we position narmafotinib as the preferred drug to enhance the effectiveness of existing chemotherapy combinations in pancreatic cancer.”
