Australian pharmaceutical company Amplia Therapeutics (ASX:ATX) has received approval from the Korean Ministry of Food and Drug Safety (MFDS) for the second phase of an ACCENT clinical trial.
The clinical trial will include the testing of Amplia’s narmafotinib (AMP945) product in combination with gemcitabine and Abraxane in advanced pancreatic cancer patients in Korea.
Amplia’s drug, narmafotinib, is an inhibitor of the enzyme focal adhesion kinase (FAK), which is a non-receptor tyrosine kinase that acts as a primary regulator of focal adhesion signalling to regulate cell proliferation, survival, and migration.
Essentially, it’s designed to make cancers more vulnerable to current approved treatments.
Meanwhile, gemcitabine and Abraxane help control or slow the spread of cancer cells.
Phase two of the ACCENT trial is designed to assess the efficacy of the triple drug combination, with the primary endpoint being objective response rate (ORR) and secondary endpoints including progression-free survival (PFS) and overall survival (OS).
Amplia says 5 preselected clinical trial sites in Korea can be opened ‘shortly’ to begin enrolment of patients.
In November 2023, 6 sites were opened in Australia. Experience at these sites with the initial 1B phase of the ACCENT trial will help optimise the recruitment and management of patients in the phase two stage of the trial in Australia and Korea.
Amplia Therapeutics Managing Director and Chief Executive Officer (CEO) Chris Burns says the approval comes after months of hard work from the company, which has worked closely with Korean regulators to achieve this.
“The Korean health system and their clinical trial capability are world-class, and recruitment into pancreatic cancer trials has been historically strong.
“The Korean health system and their clinical trial capability are world-class”
We look forward to opening our planned sites in Korea and working with the excellent clinical groups to further test the impact of our drug narmafotinib in the treatment of advanced pancreatic cancer.”
Amplia Therapeutics is an ASX-listed pharmaceutical company focused on advancing a pipeline of FAK inhibitors for cancer and fibrosis.
Images: Amplia Therapeutics