Melbourne, Australia – Regenerative medicine company Exopharm Limited (ASX:EX1) announces the start of the PLEXOVAL Phase 1 study, the first human clinical trial using exosomes for wound healing.
This is an important step forward as a clinical-stage company and 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.
Exopharm was recently granted Human Research Ethics Committee approval to commence the PLEXOVAL wound healing study with its PlexarisTM (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 2involves 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 practicing dermatologist and dermatopathologist and a Fellow of Australasian College of Dermatologists.
The study is being facilitated by Accelagen, a Melbourne based Contract Research Organisation (CRO).
Dr. Ian Dixon, Exopharm’s Founder CEO and Managing Director said:
“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 the safety of the product and potentially show signs of efficacy.”
Exopharm is manufacturing the Plexaris product at its Fitzroy manufacturing facility.
For further company and media information contact:
Dr Ian Dixon
Phone: +61 (0)3 9111 0026
Phone: +61 (0)3 9620 3333
Exopharm Limited is an Australian regenerative medicine biopharmaceutical company that is listed on the Australian Securities Exchange (ASX:EX1) seeking to develop and commercialise exosomes as therapeutic agents – initially a product called Plexaris™ and later a product called Exomeres™.
These products are exosomes that are derived from human platelets in relation to Plexaris, and adult stem cells in relation to Exomeres, and purified using the LEAP Technology and referred to as biologic products.
As its primary focus, Exopharm aims to be a leader in the field of human therapeutics using exosomes as regenerative medicine products for heath span related conditions.