- Results from Amplia Therapeutics’ (ATX) recent clinical trial shows its treatment for cancer and fibrosis is safe and well tolerated in all doses tested
- The study on 56 healthy volunteers focussed on the safety and tolerability of AMP945 when orally administered
- No withdrawals or serious adverse events were recorded during the trial, with a mild headache being the most common reaction
- The company is now planning its next steps for the drug, with phase two trials in pancreatic cancer expected to start towards the end of 2021
- Amplia Therapeutics last traded at 21 cents on July 20
Results from Amplia Therapeutics’ (ATX) recent clinical trial have shown its treatment for cancer and fibrosis was safe and well tolerated in all doses tested.
Unblinded results from a phase one clinical trial of AMP945 confirmed the company’s preliminary analysis and supported its progression into later stages of clinical development.
The study was conducted at Nucleus Network in Melbourne and focussed on the safety and tolerability of AMP945 when orally administered via a capsule.
56 healthy volunteers, ranging from the ages of 18 to 65, were given either single or multiple doses of up to 125 milligrams of AMP945 or a placebo over seven days, with some also given food before and after the dosages.
The trial looked into the severity of adverse events as a result of the doses and assessed biochemical and haematological markers.
No withdrawals, significant changes in vital signs or serious adverse events were recorded during the trial, with a mild headache being the most common reaction. The results also noted that food did not appear to have any effect on the absorption of AMP945.
Amplia’s CEO and Managing Director, Dr John Lambert, says the trial delivered exactly what the company wanted — a safe and tolerable drug ready for phase two trials for pancreatic cancer and pulmonary fibrosis.
“With the successful completion of this phase one trial Amplia has hit yet another significant milestone and I would like to thank our team, Amplia’s investors and the volunteers who stepped forward to participate in this successful trial,” Dr John Lambert said.
The company is now planning its next steps for the drug, with phase two trials in pancreatic cancer expected to start towards the end of 2021.
Amplia Therapeutics last traded at 21 cents on July 20.