• Exosomes have the potential to replace stem cells as medicines
• BioMAP external testing validates possible safety and mechanism of action
• Positive BioMAP testing provides a basis for further testing and future potential clinical trials
BioMAP testing of Exopharm’s exosome platform has validated safety and mechanism of action (MOA) and found that they have different and distinct activities compared to 4,500 other drugs. This confirms this therapeutic approach is a distinct and potentially new class of medicine.
Exopharm submitted its exosome products for testing under the BioMAP testing program operated by Eurofins, a European-based group of laboratories.
The headline results of the BioMAP® Diversity Plus® screen testing are:
Exopharm’s Plexaris product (exosomes from platelets) was compared with 4,500 experimental and sold medicines across a panel of 12 human primary cell-based systems. Plexaris was found to be safe (by comparison and absolute measures) and had notable biological activity in (i) tissue remodelling (ii) immunomodulatory and (iii) inflammatory-related activities.
Exopharm’s Cevaris product (exosomes from adult stem cells) was compared with 4,500 experimental and sold medicines across a panel of 12 human primary cell-based systems. Cevaris was found to be safe (by comparison and absolute measures) and had notable biological activity in (i) tissue remodelling, (ii) inflammatory and (iii) immune-modulatory-related activities.
“These are very positive results from a detailed external test of two of our experimental exosome products,” says Dr Ian Dixon, founder and CEO of Exopharm.
“The testing showed that both Plexaris and Cevaris had different and distinct activities to comparison drugs. This confirms our belief that exosomes are a distinct and potentially new class of medicine, different from existing medicines,” he adds. “Importantly, neither was shown to be cytotoxic, and neither caused antiproliferative effects at the concentrations tested.”
The BioMAP results “have a positive impact” across Exopharm’s business, and “will be of interest to potential partners,” Dr Dixon says. “Our testing is looking at issues of safety, mechanism of action and potency, and these results point to an expected safety profile and where these products could be best directed to serve patients.”
In summary, Dr Dixon says, the BioMAP results point to the potential value of Exopharm’s world-leading exosome products as medicines. Further testing is required to validate these products.
The BioMAP testing provides a basis for further non-clinical testing of Exopharm’s products in selected indications based upon improved MOA knowledge, based on the limitations outlined below.
“The results of the BioMAP testing will help Exopharm plan its next studies with additional insights and confidence. After that, further human clinical trials are the next step,” says Dr Dixon.
For further media information contact:
Dr Ian Dixon
Phone: 03 9111 0026
Exopharm Limited (ASX:EX1) is a clinical-stage Australian regenerative medicine company developing therapeutic exosome products as alternatives to stem-cell therapies.
Exosomes are small particles naturally produced by cells, which deliver therapeutic ‘cargoes’ to other cells to reduce inflammation and promote regeneration. Exosomes are plentiful in our youth but decline with age. Recent research points to exosomes as a way to extend the number of healthy, functional years (extending health span).
Exosomes secreted by stem cells could be used instead of stem-cell therapy with equal or greater benefit – and without the problems of stem-cell therapies. They could be used to deliver targeted ‘novel’ drugs and have potential as diagnostics.