Enormous costs are imposed by regulators in the US and Europe on the process of manufacturing a candidate drug to Good Manufacturing Practice (GMP) standards and then running a first clinical trial. Combine this with three years of a bad market for biotech, in which investors have pulled back from investing in preclinical companies, and one sees a much greater pressure than usual to expand alternative paths to obtaining initial human data in a responsible way. Right to Try initiatives within the US are underway, and ever more groups within the medical tourism industry are attempting to position themselves as service providers for an alternative to a first clinical trial in the US or Europe. Próspera in Honduras is the most visible of a fair number of entities. At the end of the day, much of the cost and requirements imposed by the FDA and other bodies are not necessary for responsible safety. When regulators make the task of conducting manufacture and a safety trial in humans cost $20M, but it can actually be accomplished responsibly for $5M, as is the case for many classes of therapy, something must change - and change is coming.
Mitrix Bio has reported preliminary Phase 1 safety results for what it describes as large infusions of transplanted mitochondria in humans, while simultaneously launching a small network of clinics offering the experimental intervention under Right to Try frameworks. Taken together, the announcements mark a transition from laboratory concept to early clinical deployment - albeit on a limited scale.
The initial safety work was conducted at a clinic in Dallas, Texas, involving two older participants who received escalating doses of transplanted mitochondria, with monitoring of blood chemistry and physical condition throughout. According to the company, no obvious adverse effects were observed during the study period. Alongside this, new Mitochondrial Transplant Institute clinics have opened in Newport Beach, Dallas and Palm Beach, where treatments will be offered on an individualized basis by physicians, targeting a wide range of chronic and degenerative conditions.
Mitrix's approach involves the use of bioreactors to grow mitochondria derived from an individual's own cells, with the aim of enabling larger-scale infusions. In the recent safety study, doses were increased incrementally, allowing investigators to assess tolerability before proceeding further. The absence of immediate adverse effects supports continued investigation, and though efficacy data has not yet been released, the company is aiming for full efficacy data by the end of this year.
Link: https://longevity.technology/news/mitrix-moves-mitochondria-into-the-clinic/
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