(ASX:PXS) has announced that its novel topical drug treatment for scarring has delivered positive phase one clinical trial results and will now advance to the next stage of development in patients.
The company said in a study of healthy volunteers led by renowned surgeon Professor Fiona Wood AM the Pharmaxis drug demonstrated good tolerability and full inhibition of the enzymes being targeted to prevent scarring.
The phase one trial of the drug known as PXS-6302 tested four different strengths formulated as an easy to apply cream in four subjects as a single dose, scaling to the highest dose applied daily for seven days in a further six subjects.
The positive results from the study have now triggered the next steps in initiating a longer-term study in patients with scars.
The study was conducted by a research team at the University of Western Australia (UWA) and Fiona Stanley Hospital.
"Scars are a constant reminder of trauma with both physical and psychological impact. Our aim is to reduce the scar and reduce the impact. We have two studies planned with Pharmaxis; this first one in established scars and an additional one in patients with burn injuries after they have had surgery," said Professor Wood.
Dr Kylie Sandy-Hodgetts, senior research fellow at the School of Biomedical Sciences, UWA, and principal investigator on the study said, "Based on the encouraging results from the phase 1 study in healthy volunteers, we are now preparing for a study in patients with established scars. We will be investigating the safety of 3 months' treatment with PXS-6302, and exploring if 3 months' treatment with PXS-6302, at a dose that we now know will significantly inhibit an enzyme implicated in scar formation, can make a difference to both the appearance and structure of their scars."
Pharmaxis said its discovery has shown promising results in pre-clinical models of scar tissue development under the direction of Dr Mark Fear, senior research fellow at the Stan Perron Centre for Excellence in Childhood Burns.
Dr Fear commented on the background to the forthcoming study in patients with established scars, "We now understand from our research that even scars which are stable and many years old are in fact replenishing a significant proportion of mature, stiff collagen in a matter of a few months. This presents an opportunity for a drug like PXS-6302 to potentially improve even established scars."
PXS-6302 was discovered by the Pharmaxis research team at the company's laboratories in Sydney. The project was supported by a National Health and Medical Research Council (NHMRC) development grant funding extensive pre-clinical work executed in collaboration with UWA. The clinical trials in patients with established scar and patients with burns will both be conducted at the Fiona Stanley Hospital in Perth with financial support from Pharmaxis.
