Exopharm backs regulatory crackdown on unapproved exosome products
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.”