Exopharm Limited has received approval from Melbourne Health Human Research Ethics Committee to commence the PLEXOVAL wound healing study with its Plexaris™ 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. Cohort 1 involves 15 participants and Cohort 2 involves 5 participants.
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. Study site contracts, study initiation and then commencement of participant recruitment are next steps.
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 and the PLEXOVAL study will be a worldfirst to apply this type of product in a Phase I study looking at both safety and signs of efficacy.”
Exopharm has transitioned from being a manufacturing R&D company into a clinical stage drug development company over the past 12 months. The Exopharm team now comprises experienced experts in all areas of the business; including manufacture, analytics, testing, intellectual property, partnering and experimental biology.
Dr Dixon said “This PLEXOVAL study is just one piece of our comprehensive development program – all aiming to deliver partnerships and licence transactions. Potential partners are interested in access to our LEAP Technology, engineered exosomes and uses of Plexaris and Exomeres for various other medical indications.”
Recent pre-clinical research from peer reviewed papers points to exosomes as a regenerative medicine being relevant to many health span related medical conditions including skin, liver, brain, vascular, cardiac, joints, bones and eyes. Pending a successful completion of the first-in-human PLEXOVAL study, Exopharm anticipates a further study with allogeneic (unmatched) Plexaris product. The PLEXOVAL study is a part of Exopharm’s strategy to demonstrate its capabilities in manufacturing, clinical testing and scientific review.
Source – Exopharm