- Ampila Therapeutics (ASX:ATX) has won initial approval from the US FDA
- That approval awards its investigational new drug (IND) status
- IND status allows a company to fast-track through the FDA bureaucracy
- The company wants to combine one drug with another type of chemo drug to boost outcomes
- Shares last traded at 8.1 cents
Ampila (ASX:ATX) has told the market it is the recipient of a positive clearance from the US Food and Drug Administration (FDA) regarding an application for investigational new drug (IND) status.
The FDA is the peak American medical regulator a counterpart to the Australian TGA; IND status allows companies with experimental drugs to be fast-tracked through the onerous tier-1 approvals system.
Pancreatic cancer focus
Ultimately, Ampila is seeking to use an existing drug in its IP catalogue in the treatment of pancreatic cancer.
A proposed trial – not yet entirely approved but with an FDA green tick behind it, anticipated to go ahead – will look at the safety, tolerability and efficacy of the treatment in question.
Narmafotinib will be used alongside two chemotherapy drugs – gemcitabine and Abraxane – in advanced pancreatic cancer patients in both Australia and South Korea.
The US application cleared by the FDA seeks to combine narmafotinib in combination with a different chemo drug, Folfirinox (“a four drug regimen”), which Ampila states is widely used in the US for pancreatic cancer.
Management comment
“We will now start planning the combination trial of narmafotinib with FOLFIRINOX in the US, which expands the clinical opportunities for our best-in-class FAK inhibitor,” Ampila CEO Dr Chris Burns said.
An FAK inhibitor is intended to stop the spread of cancer in the body as opposed to destroying cancer cells outright; when used in combination with chemo or radiotherapy, Ampila believes they can maximise patient outcomes post-recovery.
“FOLFIRINOX is the preferred treatment for pancreatic patients in the USA and most of Europe, and therefore this combination trial is highly relevant as we position narmafotinib as the preferred drug to enhance the effectiveness of existing chemotherapy combinations in pancreatic cancer.”
ATX shares last traded at 8.1 cents.