MELBOURNE, Australia--(BUSINESS WIRE)--A leading developer of exosome therapies, Australia-based Exopharm Limited, supports the US Food & Drug Administration (FDA) in highlighting the health dangers of unapproved products peddled by clinics that are openly flouting the rules.
In a public safety notification released on December 6, the FDA highlighted reports of serious adverse health events in patients given unapproved products claimed to contain exosomes.
According to the report, the dispensing clinics “deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions.”
This behaviour “ultimately puts at risk the very patients that these clinics claim to want to help.”
Exopharm's approach to developing exosome therapeutics is vastly different to that of the dubious operators.
In concert with other research-led biomedical companies, Exopharm is working with regulators such as the FDA to develop to test the safety and efficacy of their candidate exosome therapies as cautiously and thoroughly as needed.
The FDA report makes it clear the regulator takes issue with the clinics flouting the rules, rather than the exosomes themselves.
Exosomes are small particles naturally produced by cells, which deliver therapeutic ‘cargoes’ to other cells to reduce inflammation and promote regeneration.
The FDA will continue to work closely with investigators and firms legitimately working on exosome development and will do so “in the most effective manner possible while meeting the FDA’s standards for safety and efficacy.”
Along with other legitimate entities, Exopharm’s path to regulatory approval is based on an established route that highlights the safety of any new drug.
The first critical point is to develop a safe, robust and reliable exosome production method, which gives a highly consistent product from batch to batch. With its LEAP exosome isolation and purification technology, Exopharm has focused on this aspect since day one.
Before starting its first human clinical trials in August 2019, the company received human research ethics committee approval as well as consent under the Australian Clinical Trials Notification (CTN) scheme.
The FDA says: “We look forward to working with those who share our goal of bringing safe and effective products to market to benefit individuals in need.”
As a legitimate operator in this fast emerging field, Exopharm echoes that statement wholeheartedly.
- Public Safety Notification on Exosome Products
- The power of LEAP Technology
- Exopharm, PLEXOVAL Study Announcement
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.
While trillions of exosomes are produced by stem cells, the real challenge is to ‘purify’ them as drug products. Exopharm owns a purification technology called Ligand-based Exosome Affinity Purification (LEAP). LEAP technology and associated know-how places Exopharm at the forefront of this emerging field worldwide. Exopharm is at clinical stage with pending and current trials for wound healing, dry aged-related macular degeneration and osteoporosis.
Exopharm was founded in 2013 by Dr Ian Dixon, co-founder of the ASX-listed stem-cell therapy developer Cynata Therapeutics. He was also a director of Cell Therapies, which produced adult stem cells for ASX-listed stem cell company Mesoblast. Exopharm listed on the ASX in December 2018.