FDA clearance of Amplia's IND for pancreatic cancer trial in US


Amplia Therapeutics has today announced that the US FDA has cleared Amplia’s IND application for a trial of Amplia’s best-in-class FAK inhibitor narmafotinib in pancreatic cancer.  

The proposed trial will explore the safety, tolerability and efficacy of a combination of narmafotinib with the chemotherapy regime FOLFIRINOX. 

FOLFIRINOX is widely employed in the US and Europe for the treatment of pancreatic cancer. Amplia is currently undertaking a clinical trial of narmafotinib, in combination with the chemotherapeutics gemcitabine and Abraxane®, in advanced pancreatic patients in Australia and South Korea. 

Amplia CEO and MD Dr Chris Burns commented:  

“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 narmafotinib 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 US 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.” 

Click here to read the ASX release.