Australian pharmaceutical company Amplia Therapeutics has received approval from the US Food and Drug Administration (FDA) for an IND application enabling the commencement of a trial of narmafotinib.
This clearance is a significant step for the company’s clinical trial of the focal adhesion kinase (FAK) inhibitor to treat pancreatic cancer.
The upcoming trial will assess the tolerability, safety and efficacy of narmafotinib plus the FOLFIRINOX chemotherapy regimen.
The combination therapy will be tested in patients with advanced pancreatic cancer.
Currently, Amplia is conducting a Phase IIa trial of narmafotinib in Australia and South Korea.
This trial is evaluating narmafotinib along with two other chemotherapy drugs, gemcitabine and Abraxane, to treat advanced pancreatic cancer patients.
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The IND application approved by the FDA, however, supports the usage of narmafotinib with FOLFIRINOX, a four-drug regimen commonly used in the US for this cancer type.
The IND submission included a comprehensive dossier with all the preclinical and clinical findings accumulated for narmafotinib so far.
It also contained comprehensive chemistry, manufacturing and controls information.
The final document, with more than 10,000 pages, was the culmination of several months of work by the company.
Amplia CEO and MD Dr Chris Burns said: “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.”
Amplia is advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for the treatment of cancer and fibrosis.
FAK is a key target in oncology, and the company is particularly focused on developing treatments for fibrotic cancers such as pancreatic and ovarian cancer.
This inhibitor also has a substantial role in various chronic ailments such as idiopathic pulmonary fibrosis.