Amplia Therapeutics (ASX:ATX) on Wednesday revealed its receipt of approvals from the Australian Safety Review Committee (SRC) to increase dosages of its novel treatment being used in an ongoing pancreatic cancer trial.
The company’s ‘ACCENT’ trial kicked off in August last year.
The first stage of the trial saw 12 participants with pancreatic cancer take Ampila’s in-house patented medical treatment AMP945 in combination with a drug called Abraxane, an oral tablet chemotherapy drug.
The SRC has now allowed Amplia to escalate the dosages of AMP945 given to participating patients in the trial, as well as kick off recruitment of a second patient cohort.
SRC determined the treatment was so far safe and medically sound to continue using for the trial, and greenlit higher dosages for patients.
“We are delighted that the data we have collected for AMP945, when used in combination with [chemotherapy drugs] gemcitabine and nab-paclitaxel, supports dose escalation in the second cohort of patients,” Amplia chief Dr. Chris Burns said.
AMP945 is a drug developed by Ampila classified by the company as a Focal Adhesion Kinase (FAK) inhibitor.
FAK is a protein naturally occurring in humans which effectively regulates cell proliferation in the human body.
In patients with non-blood cancers, FAK is typically found at higher concentrations in the human body than that in a healthy background patient representative of the larger population.
The company’s flagship commercial strategy sees it developing a line of FAK inhibitors intended to treat cancer and fibrotic tissue diseases.
Multiple research articles posit FAK indirectly supports the spread of cancer through the body by allowing the spread and proliferation of cancerous cells.
“The performance of AMP945 appears to be tracking well, and is aligned with our expectations based on the excellent profile AMP945 demonstrated in the previous Phase 1 clinical trial in healthy volunteers,” Burns added.
With the trial, Ampila is ultimately seeking to test the veracity of its hypothesis that by inhibiting FAK from being able to “communicate” with other cells, the AMP945 treatment may be able to slow down the spread of cancer.
Cancerous growths in the human body, the theory goes, would thereby be more vulnerable to chemotherapy and radiotherapy, ultimately boosting the chance of securing heightened survival outcomes for affected patients.
Get the latest news and insights direct to your inbox