Melbourne, Australia – Exopharm Limited (ASX:EX1) has received approval from Melbourne Health Human Research Ethics Committee to commence the PLEXOVAL wound healing study with its PlexarisTM product under the Australian Clinical Trials Notification (CTN) arrangement.
This first-in-human clinical trial will investigate autologous (from the same person) Plexaris (exosomes from blood platelets) administered once and will track participants over 42 days from dosing.
The PLEXOVAL study is a Prospective open-Label, single dose proof of concept study to Evaluate the safety, tolerability and biological activity of Platelet-derived Extracellular Vesicles, on the augmentation of wound healing and is defined as a Phase I study.
Plexaris is an experimental exosome product derived from human blood platelets and purified using Exopharm’s own LEAP Technology. The main readouts of the study will be safety, wound closure and scar formation.
Dr Ian Dixon, Exopharm’s Founder CEO and Managing Director said, “This approval is the result of some outstanding work by our team, together with key support from our partners.
“Exosomes represent a new modality to treat a variety of conditions”, says Dixon, “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.”
The PLEXOVAL study is a part of Exopharm’s strategy to demonstrate its capabilities in manufacturing, clinical testing and scientific review.
Read the full ASX Announcement here: https://exopharm.com/asx-announcements/
Exopharm Limited is an Australian regenerative medicine biopharmaceutical company which is listed on the Australian Securities Exchange (ASX:EX1) seeking to develop and commercialise exosomes as therapeutic agents – initially a product called Plexaris™ and later a product called Exomeres™.
These products are exosomes that are derived from human platelets in relation to Plexaris, and adult stem cells in relation to Exomeres, and purified using the LEAP Technology and referred to as biologic products.
As its primary focus, Exopharm aims to be a leader in the field of human therapeutics using exosomes as regenerative medicine products for heath span related conditions.