Pharmaxis announced that a phase 1c trial of its novel topical drug treatment for scarring, has commenced dosing in patients with established scars. The study, led by renowned surgeon Professor Fiona Wood AM and researchers at The University of Western Australia (UWA), will assess the safety and tolerability of a once daily application of Pharmaxis drug PXS6302 applied to areas of established scars on adult patients. Skin biopsies will be taken in order to study the impact on scar structure as well as visual and physical assessments of the scar tissue.

PXS6302 is a first in class inhibitor of the lysyl oxidase enzymes (LOX) that are involved in formation and maintenance of scars and is a potential breakthrough treatment for patients with problematic scars. Scar formation following a burn or skin injury is a considerable health issue worldwide. After an injury, people are unable to regenerate normal skin, instead the repair process leads to scar formation.

Scars are both aesthetically and functionally inferior to normal skin, leading to significant psychological and physical problems. Key factors in the poor appearance and pliability of scars, and in particular hypertrophic scars, are the changes to the structure and quantity of collagen in the dermal layer. Current treatments in a global market valued at USD 3.5 billion, aim to rectify the scar in the acute phase (i.e. during wound healing and scar maturation) through options such as compression therapy, silicone gel sheeting or later when the scar is established by cryotherapy, scar revision or laser. LOX plays a critical role in scar formation by crosslinking the collagen fibres.

The resulting changes in collagen structure and increased rigidity of the tissue stimulates greater production of collagen and LOX which in turn leads to more scar tissue. Pharmaxis and its collaborators at UWA will now test if inhibiting LOX in established scar tissue with PXS6302 can safely and effectively improve scarring when administered as a cream once a day for a 3month period. PXS6302 was discovered by the Pharmaxis research team at the company's Frenchs Forest laboratories.

The project was supported by a National Health and Medical Research Council (NHMRC) development grant funding extensive preclinical work executed in collaboration with UWA. The clinical trials in patients with established scar and patients with burns will both be conducted at Fiona Stanley Hospital in Perth with financial support from Pharmaxis.