MELBOURNE - The US Food and Drug Administration (FDA) has approved Amplia Therapeutics Limited's Investigational New Drug (IND) application to initiate a clinical trial in the United States for narmafotinib, the company's focal adhesion kinase (FAK) inhibitor. The trial will assess the safety and efficacy of narmafotinib in combination with the chemotherapy regimen FOLFIRINOX for patients with advanced pancreatic cancer.
This regulatory clearance allows Amplia, an Australian pharmaceutical company, to expand its clinical research into the United States. Currently, Amplia is conducting a Phase 2a clinical trial in Australia and South Korea, where narmafotinib is being tested alongside gemcitabine and Abraxane®. The US-based trial, however, will pair narmafotinib with FOLFIRINOX, a four-drug chemotherapy regimen commonly used in the US and Europe for treating pancreatic cancer.
The IND submission included a comprehensive dossier of over 10,000 pages, detailing preclinical and clinical data on narmafotinib as well as complete chemistry, manufacturing, and controls (CMC) information. This extensive documentation reflects the company's efforts over the past months to meet the rigorous requirements of the FDA.
Dr. Chris Burns, CEO and Managing Director of Amplia, expressed that the FDA's clearance marks a significant advancement for the company. He noted the relevance of the upcoming trial, as FOLFIRINOX is a preferred treatment for pancreatic cancer in the US, and emphasized the potential of narmafotinib to enhance the effectiveness of existing chemotherapy treatments for this aggressive cancer.
Amplia Therapeutics focuses on developing FAK inhibitors for the treatment of cancer and fibrosis, with a particular interest in fibrotic cancers such as pancreatic and ovarian cancer. FAK is a key target in cancer research due to its role in the progression of various chronic diseases, including idiopathic pulmonary fibrosis (IPF).
The company's progress in advancing its pipeline of FAK inhibitors is based on the press release statement issued by Amplia Therapeutics. The planned US trial will contribute to the growing body of research on potential treatments for pancreatic cancer, a disease with historically limited treatment options.
This news is based on a press release.
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