Melbourne-based regenerative medicine company Exopharm (ASX:EX1) has announced the first dosing has occurred in the PLEXOVAL phase 1 study using exosomes isolated from human platelets for wound healing.
It is the company's first human clinical trial. Further participants are expected to soon follow in this study that involves up to 20 participants.
The company said the first dosing in the PLEXOVAL study is a key milestone. According to Dr Ian Dixon, Exopharm’s founder and CEO, “The first dosing of the PLEXOVAL study positions Exopharm as a clinical stage leader in the cell-free exosome field of regenerative medicine. It is a great achievement for our team to test our exosome product in this Phase 1 study, which is a world first.
"Our LEAP Technology allows us to manufacture an advanced exosome product. We believe our progress will be closely watched by industry players and potential partners.”
The company said exosomes show great promise across a range of age-related medical conditions including problems with mobility and sensory function, but the number of companies capable of manufacturing sufficient quality and quantities of exosome products at the clinical level is still very limited.
Exopharm said it was granted Human Research Ethics Committee approval to commence the PLEXOVAL wound healing study with its Plexaris (exosomes from platelets) autologous product under the Australian Clinical Trials Notification (CTN) scheme in 2019.
“Platelets have a well-established safety profile from millions of transfusions annually, so Plexaris™ is an excellent first step in our regulatory journey toward commercialising the medical use of a variety of exosome products in humans,” said Dr Chris Baldwin, Chief Commercial Officer.
The main readouts of the PLEXOVAL study will be safety, wound closure and scarring. Subject to successful recruitment and throughput, a study report will be provided to Exopharm, at this stage expected in the second half of 2020.
“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. 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 for medical professionals and potential partners,” added Dr Dixon.