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Amplia Therapeutics’ (ASX:ATX) preliminary toxicology supports phase one clinical trial
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  • Amplia Therapeutics (ATX) has successfully completed a single-dose study of its proprietary focal adhesion kinase (FAK) inhibitor AMP945
  • The Melbourne-based pharmaceuticals company is developing new approaches for the treatment of cancer and fibrosis
  • The single ascending dose component of the phase one clinical trial involved four cohorts of healthy volunteers
  • The last cohort received the highest single dose of the AMP945 administered to date, achieving drug exposures corresponding to the maximum allowable level
  • AMP945, in its highest dose, was found to be well-tolerated among volunteers with no safety concerns identified
  • Amplia is on track to complete dosing and report top-line trial data in the June quarter
  • Amplia Therapeutics shares are up 5.88 per cent, trading at 27 cents each

Pharmaceuticals company Amplia Therapeutics (ATX) has successfully completed a single dose study of its proprietary focal adhesion kinase (FAK) inhibitor AMP945.

Amplia, based in Melbourne, is developing new approaches for the treatment of cancer and fibrosis.

The company tested the drug on four cohorts of healthy volunteers in the single ascending dose (SAD) component of its phase one clinical trial.

The last cohort received the highest single dose of AMP945 that has been administered to date to achieve drug exposures corresponding to the maximum allowable level specified in the trial's design.

The drug, in its highest dose, was found to be well tolerated among the participants with no safety concerns identified.

Amplia Resources CEO Dr John Lambert said data coming in from the study is encouraging.

"Our focus is now on completing the trial in a timely manner, fully analysing the data and preparing for future clinical studies in patients with cancer and fibrosis," he commented.

Amplia started dosing subjects for the multiple ascending dose (MAD) component of the phase one trial last month and remains on track to complete dosing and report top-line trial data in the June quarter.

FAK is an increasingly important target in the field of cancer immunology and also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis.

Amplia Theraputics shares are 5.88 per cent higher on Wednesday, trading at 27 cents at 1:03 pm AEDT.

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