Exopharm starts phase 1 wound healing trial

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Regenerative medicine company Exopharm (ASX:EX1) has announced the start of its PLEXOVAL Phase 1 study, the first human clinical trial using exosomes for wound healing.

The company described it as an important "step forward" as a clinical-stage company and 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, it said.

Exopharm was recently granted Human Research Ethics Committee approval to commence the PLEXOVAL wound healing study with its Plexaris (exosomes from platelets) product.

The trial is approved under the Australian Clinical Trials Notification (CTN) scheme. This first-in-human clinical trial will investigate autologous (from the same person) Plexaris (exosomes from blood platelets) administered once by local injection. The study will track participants over 42 days from dosing. Cohort 1 involves up to 15 participants and Cohort 2 involves up to 5 participants.

The main readouts of the PLEXOVAL study will be safety, wound closure and scarring.

The principal investigator of the study is Associate Professor Johannes Kern MD, PhD, FEBDV, FACD of the Dermatology Department, Royal Melbourne Hospital. The principal investigator is a practising dermatologist and dermatopathologist and a Fellow of Australasian College of Dermatologists.

The study is being facilitated by the Melbourne-based Contract Research Organisation, Accelagen.

According to Dr Ian Dixon, Exopharm’s founding CEO and managing director, “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.

“This PLEXOVAL study positions Exopharm as a leader in the cell-free exosome field of regenerative medicine world-wide. Our LEAP Technology allows us to manufacture an exosome product that has the properties a pharmaceutical company would look for. The main purpose of this small study is to demonstrate safety of the product and potentially show signs of efficacy.”

Exopharm is manufacturing the Plexaris product at its Melbourne manufacturing facility.