23 July 2019
As reported in Biotech Daily
Exopharm says it is ready for a 20-patient phase I trial of its Plexaris exosomo treatment for would healing, and has requesting a trading halt for a capital raising.
Exopharm said it had been approved by the Melbourne Health ethics committee to begin its ‘Ploxoval’ trial of autologous, or one’s own, exosomos derived from blood platelets.
The company said the exosome product was purified using its Leap technology which was a “manufacturing process to isolate and purify exosomes from adult stem cells and other sources”.
Exopharm said the prospective, open-label, single dose, proof-of-concept study would track participants for 42 days after dosing to evaluate the safety, tolerability and biological activity of platelet-derived extracellular vesicles on the augmentation of wound healing.
The company said the primary endpoints of the study were safety and efficacy in wound closure and scar formation.
Exopharm chief executive officer Dr Ian Dixon said “exosomes represent a new modality to treat a variety of conditions and the Plexoval study will be a world-first to apply this type of product in a phase I study looking at both safety and signs of efficacy.”
Exopharm said trading would resume on July 24, 2019 or on an earlier announcement.
Exopharm last traded at 44.5 cents.