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Amplia Therapeutics (ASX:ATX) receives ethics approval for phase one FAK trial
  • Amplia Therapeutics (ATX) has received ethics approval to conduct phase one of its clinical trial for its Focal Adhesion Kinase (FAK) inhibitor, AMP945, which aims to treat both cancer and fibrosis
  • The trial will test the treatment on up to 64 healthy adult volunteers
  • Amplia hopes the trial will establish the safety profile of oral doses of AMP945
  • Now armed with ethics approval, the company expects to initiate its phase one trial in the coming weeks, with the first subject likely to be dosed by early October
  • Amplia is up 11.5 per cent on the market today and is trading for 14.5 cents per share

Amplia Therapeutics (ATX) has received the tick of approval from the Alfred Hospital Human Research Ethics Committee (HREC) to conduct a phase one clinical trial.

The clinical trial is for Amplia's Focal Adhesion Kinase (FAK) inhibitor, AMP945, which aims to treat both cancer and fibrosis.

With this approval, the company is expecting to initiate its phase one trial in the coming weeks, with the first subject likely to be dosed by early October.

The trial is to establish the safety profile of oral doses of AMP945 in up to 64 healthy adult volunteers, as well as provide data on the drug's impact on humans. Amplia said recruitment for the trial is not expected to be impacted by COVID-19.

Data from this trial will be used to support phase two for the treatment of patients with specific, hard-to-treat cancers or with certain fibrotic diseases.

Earlier this year, Amplia received Orphan Drug Designations (ODDs) from the U.S. Food and Drug Administration (FDA) for the use of AMP945 in the treatment of pancreatic cancer and idiopathic pulmonary fibrosis (IPF).

CEO Dr John Lambert is excited with the ethics approval.

"Despite the challenges thrown up by the current COVID-19 pandemic, in the past
few months we have managed to secure two Orphan Drug Designations, complete the preclinical studies required to support the phase one trial, secure funding to conduct the trial, and now receive the approval required to initiate the trial," he said.

"We are extremely grateful for the support we have received from our partners, providers and shareholders that has allowed us get to this stage and initiate
the first-in-human study for AMP945," he added.

Amplia is up 11.5 per cent on the market this morning and is trading for 14.5 cents per share at 11:46 am AEST.


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