AMPLIA TO CONDUCT PHASE 2 TRIAL IN FIRST-LINE PANCREATIC CANCER PATIENTS
• First-line cancer patients to be assessed in Phase 2 clinical trial of AMP945
• Provides access to largest relevant patient population for the clinical trial
• Patient recruitment planned to start in Q1 2022
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”, a
company developing new drugs for the treatment of cancer and fibrosis, is pleased to announce it has
completed the design for a Phase 2 clinical trial of its Focal Adhesion Kinase (FAK) inhibitor, AMP945.
This trial will be conducted in newly diagnosed patients receiving first-line therapy for pancreatic
cancer.
Amplia’s planned Phase 2 clinical trial will add AMP945 to chemotherapy with gemcitabine and nab-
paclitaxel, which is a standard of care currently used to treat the majority of newly diagnosed advanced
pancreatic cancer patients. In the trial, designated AMP945-202, AMP945 will be administered orally
to patients prior to each dose of their standard gemcitabine/nab-paclitaxel chemotherapy. The design
of this trial is based on studies conducted in collaboration with Professor Paul Timpson’s group at the
Garvan Institute of Medical Research, Sydney, where it has been shown that intermittent dosing of
AMP945 makes tumours more responsive to standard chemotherapy treatments in animal models of
pancreatic cancer.
Conducting the Phase 2 clinical trial in first-line patients is expected to expedite recruitment for the
trial and provides the best opportunity to detect any efficacy signal from the addition of AMP945 to
chemotherapy. The ability to test AMP945 in a first-line setting is also made possible by the excellent
safety and tolerability profile demonstrated in Amplia’s recent Phase 1 clinical trial.
Dr Adnan Nagrial, of Sydney’s Westmead Hospital and lead investigator on the trial, commented that
“Patients with advanced pancreatic cancer have very limited treatment options and we desperately
need new therapies with novel mechanisms of action. Based on the evidence we have seen so-far, FAK
inhibitors deserve to be tested in the clinic and I am excited to be part of this trial”.
The Phase 2 trial of AMP945 will be an open-label single arm trial conducted in two stages. In the first
stage, an optimal dose of AMP945 will be selected and a preliminary assessment of efficacy will be
performed in approximately 40 pancreatic cancer patients. In the second stage, up to an additional 24
pancreatic cancer patients will be recruited in order to increase confidence in the preliminary results.
All patients are expected to receive multiple rounds of treatment.
The Company plans to initiate patient recruitment at Australian sites in the first quarter of 2022.
Currently, the Company expects that recruitment will take 18-24 months but is working with vendors
to accelerate key aspects of the trial. The primary endpoint for the trial will be based on the objective
response rate from treatment compared to historical controls. In addition, multiple other signals of
efficacy will be assessed in the trial’s secondary and exploratory endpoints including duration of
response, disease progression rates, survival and effects on biomarkers of disease. “Clinical evaluation of AMP945 as part of a first-line treatment for pancreatic cancer significantly
de-risks the program and makes the drug relevant for a much larger patient base.” said Dr John
Lambert, CEO of Amplia Therapeutics. “If we are able to see positive signs that AMP945 improves the
leading current treatment option we will commence discussions with regulators and potential partners
concerning future trials required to support product approval.”
This ASX announcement was approved and authorised for release by the Board of Amplia
Therapeutics.
ATX Price at posting:
20.0¢ Sentiment: Hold Disclosure: Held
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