- Amplia Therapeutics has received second HREC clearance for Phase 2 clinical trial of AMP945
- The approval will allow the company to accelerate recruitment into the trial and focus on its execution phase
- The trial is designed to evaluate the optimal dose of AMP945 based on safety, pharmacokinetic and pharmacodynamic measures
ASX-listed clinical-stage drug development company Amplia Therapeutics Limited (ASX: ATX) has achieved a major milestone in its journey to develop a treatment for pancreatic cancer. The pharmaceutical company has received second approval from the Human Research Ethics Committee (HREC) for conducting a Phase 2 clinical trial of its Focal Adhesion Kinase (FAK) inhibitor, AMP945, in first-line patients with advanced pancreatic cancer.
Amplia is progressing a pipeline of FAK inhibitors for cancer and fibrosis. FAK is a critical target in cancer immunology, and Amplia is specially focused on pancreatic and ovarian cancer treatment.
Last month, the company received an HREC approval for commencing the trial in New South Wales. However, the company was expecting the outcome of a second pending HREC application covering sites in Victoria, Australia.
With no further HREC approvals pending, the company will accelerate recruitment into the trial, shifting its focus to the trial’s execution phase.
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Phase 2 clinical trial
The trial is designed to assess the optimal dose of AMP945 in nearly 12 patients. The optimal dose will be determined based on safety, pharmacokinetic and pharmacodynamic measures.
After finding out the optimal dose, about 26 first-line patients will be treated with the optimised dose of AMP945 in combination with gemcitabine and nab-paclitaxel. Amplia will use data from the trial to conduct an interim analysis around mid-2023.
In February, Amplia, in association with its collaborator Garvan Institute, demonstrated that AMP945 could improve the current standard of care in a second model of pancreatic cancer. The compound has the potential to enhance the effectiveness of gemcitabine/Abraxane® in a model of human pancreatic cancer.
At the time of writing this article (FRI 13 MAY 10:32 AM AEST), shares of Amplia were trading at AU$0.12.
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