Total
0
Shares
Amplia Therapeutics’ (ASX:ATX) preliminary toxicology supports phase one clinical trial
  • Amplia Therapeutics (ATX) has received preliminary results from a preclinical toxicology study for its focal adhesion kinase (FAK) inhibitor, AMP945
  • FAK inhibitors work to suppress tumour growth by blocking signalling pathways responsible for cell growth and proliferation
  • The results indicate no observed adverse effects, meaning planning for the phase one clinical trial is likely to go ahead
  • The preclinical toxicology results are an important step as the company progresses toward creating a novel treatment for pancreatic and ovarian cancers, as well as other chronic diseases
  • Amplia Therapeutics shares are trading 4.2 per cent higher at Tuesday's close, valued at 12.5 cents per share

Amplia Therapeutics (ATX) has received preliminary results from a preclinical toxicology study for its focal adhesion kinase (FAK) inhibitor, AMP945.

The results indicate no observed adverse effects, meaning planning for a phase one clinical trial is likely to go ahead.

Green light

FAK inhibitors work to suppress tumour growth by blocking signalling pathways responsible for cell growth and proliferation.

FAK inhibitors are increasingly being sought as a complement to immunotherapy in cancer treatments, as they can help stop tumour progression.

The preliminary data of Amplia's preclinical trial, conducted under a Good Laboratory Practice (GLP) quality framework, indicate that there's no observed adverse effect level associated with repeat doses of AMP945.

The company is expecting final results in late July, at which time the phase one trial planning can begin in earnest.

The trial

If the final toxicology results prove as positive as expected, Amplia will begin planning for the phase one study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AMP945 in single and multiple doses.

The trial will also require approval from an independent human research ethics committee and funding to get it off the ground.

The study is expected to take six to nine months from first patient enrolment to final results, and is expected to be completed by mid-next year.

If results prove positive, planning for a phase two trial in solid tumour cancer patients and/or patients with fibrotic diseases, such as idiopathic lung fibrosis, can begin.

If things progress as expected, the phase two trial could begin in late 2021.

Amplia CEO and Managing Director, Dr John Lambert, says the company is making strides towards its goals.

"We are very pleased to receive the final piece of key data from the preclinical studies conducted to date," he said.

"Achieving this milestone marks an important transition for Amplia as we transform the company into a clinical-stage drug development company."

Amplia CEO and Managing Director, Dr John Lambert

Amplia is aiming its FAK inhibitor studies towards the treatment of cancer and fibrosis.

The preclinical toxicology results are an important step as the company progresses toward creating a novel treatment for pancreatic and ovarian cancers, and other chronic diseases.

Amplia Therapeutics shares are trading 4.2 per cent higher at Tuesday's close, valued at 12.5 cents per share.


Subscribe


ATX by the numbers
More From The Market Herald
Cyclopharm (ASX:CYC) - Managing Director and CEO, James McBrayer (right) - The Market Herald

" Cyclopharm (ASX:CYC) progresses U.S. FDA approval for Technegas

Cyclopharm (CYC) has announced its Technegas product is on track to receive United States Food and Drug Administration (FDA) approval in the first
Orthocell (ASX:OCC) - Managing Director, Paul Anderson - The Market Herald

" U.S. FDA clears Orthocell’s (ASX:OCC) CelGro product

Orthocell (OCC) has received Food and Drug Administration (FDA) 501K approval to supply and market its medical collagen product CelGro in the U.S.
Noxopharm (ASX:NOX) - Chief Executive Officer, Dr Graham Kelly - The Market Herald

" Noxopharm (ASX:NOX) cleared to up dosage in COVID study

Noxopharm (NOX) has been cleared to up the dosage of its COVID-19 Veyonda treatment and progress to the final stages of the dose
MGC Pharmaceuticals (ASX:MXC) - Global Chief Sales Officer, Nicole Godresse - The Market Herald

" MGC Pharmaceuticals (ASX:MXC) appoints Nicole Godresse as Global Chief Sales Officer

MGC Pharmaceuticals (MXC) has appointed Nicole Godresse as Global Chief Sales Officer, effective immediately.