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Pharmaxis moving into phase I clinical trial of its small molecule LOX inhibitor

Published: 21:11 19 Nov 2018 EST

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The compound is an all‐encompassing LOX inhibitor

Pharmaxis Ltd (ASX:PXS) has completed the preclinical package on its anti‐fibrotic Lysyl Oxidase (LOX) program focused on pancreatic cancer and will this week file an ethics submission to enable progress into a phase I clinical trial in healthy volunteers.

The trial is planned to commence in the first quarter of 2019.

WATCH: Pharmaxis advancing partnership talks for LOXL2, starting pancreatic cancer program

This is the third program from Pharmaxis’ amine oxidase chemistry platform to reach the important stage of entering human clinical trials.

The company has a successful track record of research, development and commercialisation of human healthcare products for the treatment of fibrotic and inflammatory diseases

The company has a successful track record of research, development and commercialisation of human healthcare products for the treatment of fibrotic and inflammatory diseases

Significantly, Pharmaxis is the first company to progress a small molecule LOX inhibitor into clinical development.

The compound is an oral once‐a‐day drug that inhibits all lysyl oxidase family members (LOX, LOXL1, 2, 3 & 4).

It successfully cleared pre‐clinical safety and toxicity studies in the third quarter of 2018 and has shown significant reductions in fibrosis in in‐vivo models of kidney fibrosis, lung fibrosis, myelofibrosis and pancreatic cancer.

Whereas the Pharmaxis selective LOXL2 inhibitors that are currently completing phase I studies are suited to chronic fibrotic conditions such as IPF and NASH, this all‐encompassing LOX inhibitor is well positioned for the treatment of severe fibrosis as well as cancer with prominent stroma (connective tissue) or fibrotic metastatic niches.

WATCH: The videos of the presentations at today’s onsite Investor Research Briefing

READ: Pharmaxis receives positive results from clinical trial of treatment for fibrotic diseases

Pharmaxis is collaborating with Garvan Institute of Medical Research to investigate the therapeutic potential of LOX inhibition in pancreatic cancer.  

Researchers at the Garvan Institute have evidence in mouse models that inhibition of the LOX family alters the tumour microenvironment rendering tumours more susceptible to existing therapies.

The team has also generated positive results in in-vitro and in‐vivo models of pancreatic cancer using the Pharmaxis LOX inhibitor.

READ: Pharmaxis receives positive results from LOXL2 clinical trial

Pharmaxis CEO Gary Phillips said: “Moving another a drug into the clinic further validates the productivity and expertise of our drug discovery and development team.

“This latest drug has shown real promise in pre‐clinical testing and our ambition is to move it into pancreatic cancer patients as soon as possible and demonstrate clinical proof of concept in a disease which has a very high unmet need. 

“The clinical program we envisage in pancreatic cancer is very efficient relative to other fibrotic indications so the opportunity to add significant value to the asset by taking it into phase II clinical trials prior to partnering is very attractive.”

Pharmaxis to focus on clinical-stage drug development

Pharmaxis Ltd (ASX:PXS, OTC:PMXSF) CEO Gary Phillips tells Proactive the company is set to undergo a restructure to refocus on developing drugs to treat blood-related cancers. This involves the creation of clinical stage drug development company, Syntara and the sale of its mannitol respiratory...

on 10/02/2023