- Exopharm has received approval from the Melbourne Health Human Research Ethics Committee for the ‘PLEXOVAL’ study to test the Plexaris exosome product in wound healing
- A world first study using cell free exosome product manufactured using Exopharm’s LEAP Technology
- Next steps are to seal study site contracts and recruit participants
Exopharm has received approval from the Melbourne Health Human Research Ethics Committee for the PLEXOVAL study to test the Plexaris exosome product in wound healing.
“This approval is the result of some outstanding work by our team, together with key support from our partners,” Founder, CEO and Managing Director Dr Ian Dixon said.
The Plexaris exosome product is derived from human platelets and purified using Exopharm’s Ligand-based Exosome Affinity Purification (LEAP) technology.
The company’s aim is to develop and commercialise exosomes as therapeutic agents. The first is Plexaris and later a product called Exomeres.
Recent pre-clinical research highlights exosomes as a regenerative medicine being relevant to many health span related conditions including skin, liver, brain, vascular, cardiac, joints, bones and eyes.
“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,” Dr Ian said.
The PLEXOVAL trial marks the first-in-human clinical trial for the Plexaris product.
It will investigate autologous Plexaris administered once and will track participants over 42 days from dosing. Cohort 1 involves 15 participants and Cohort 2 involves five 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.
Exopharm is in the process of completing a 12-month Development Program.
This program comprises the manufacturing of the Plexaris product and developing the Exomere product, small-scale human clinical studies of Plexaris in wound healing, research activities, and to investigate other LEAP Technology opportunities.
During this program, the Exopharm team has grown significantly and now includes experts from all areas of the business.
“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,” Dr Ian concluded.
Upon the successful completion of the first-in-human PLEXOVAL study, the company expects further study with the allogeneic Plexaris product.
Next steps include study site contracts and recruiting participants for the Phase 1 Study.