- Exopharm has begun its PLEXOVAL Phase 1 human trials
- This trial marks the first human clinical trial using exosomes for wound healing
- A total of 20 patients will be tested over a 42-day period with their results to be looked at later
- The main information to be recorded will be safety, scarring and wound closure
Regenerative medicine company Exopharm Limited has begun its PLEXOVAL Phase 1 study.
This study is the first human clinical trial using exosomes (extracellular structures) for wound healing and this is an important step to becoming a world leader in exosome therapeutics for regenerative medicine.
All regulatory and site approvals have been obtained and sites are currently preparing for the initiation of recruitment and dosing.
On July 22, Exopharm was granted Human Research Ethics Committee approval to begin the PLEXOVAL wound healing study with Plexaris.
This Phase 1 first-in-human clinical trial will investigate the autologous (from the same person) Plexaris (exosomes from blood platelets) product.
The Plexaris exosome product is derived from human platelets and purified using Exopharm’s Ligand-based Exosome Affinity Purification (LEAP) technology.
By using the LEAP technology it is hoped that the challenges normally faced with cells, such as transport, storage, distribution and administration will be nullified.
The study will track participants over 42 days beginning at the dosing. Group 1 will involve 15 participants and group 2 will have five.
The main information to be recorded will be safety, scarring and wound closure.
Plexaris and exomeres currently treat wound healing, eye degeneration and osteoarthritis, amongst other conditions, in older patients but it is hoped that one day they will be able to treat sports injuries and younger people.
“Wounds and poor wound healing are medical problems affecting thousands of Australians every year. As we age our ability to heal declines and the prevalence of chronic wounds increases,” Founder, CEO and Managing Director Dr Ian Dixon said.
“Exosomes from platelets have been shown in animal studies to improve wound closure and reduce scarring. This human study is looking at whether our Plexaris product might become a useful improved treatment option.”
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 has contacted The Australian Red Cross Blood Service to collect platelets from the participants at a regular donor centre.
The platelets will be tested at the Melbourne processing centre and then transferred to the Exopharm manufacturing site.
Exopharm will then process the samples using LEAP technology to produce each patient’s individual Plexaris product.
Participants will then visit the Royal Melbourne Hospital and have Plexaris administered by injection under the principal investigator, Associate Professor Johannes Kern.
Once the patients are treated they will be assessed over a 42 day period and study results will be entered into a data management system for later analysis.
A study report will be provided to Exopharm sometime before mid-2020.