Inside the Offshore Clinics Developing Gene Therapy to Fight Aging
In this episode, Ivan Morganov and Anna Vakrusheva, the CEO and CTO of Unlimited Bio, discuss the promise and challenges of gene therapy, the importance of the extracellular matrix in aging, and new regulatory models that could shape the future of longevity science. They share their personal backgrounds and motivations for getting involved in this field.
The conversation delves into the concept of "special economic zones" like Prospera in Honduras, where Unlimited Bio is operating. These zones aim to provide a more flexible regulatory environment for experimental therapies compared to traditional healthcare systems. However, there are concerns about oversight, quality control, and patient recourse if issues arise.
Unlimited Bio's first approved therapy in Prospera is a VEGF gene therapy for peripheral artery disease, which has been used in over 10,000 patients in Russia. The therapy is administered locally and has shown good safety and efficacy data. The company is exploring the potential of VEGF therapy for other applications like muscle function and hair growth.
The discussion shifts to other gene therapy approaches, such as AAV-based therapies targeting proteins like follistatin and Clotho. The speakers acknowledge the potential risks and challenges of systemic gene therapies compared to more localized treatments.
The conversation touches on the concept of "hallmarks of aging" and whether a targeted, one-by-one approach to addressing these hallmarks is the best path forward, or if a more holistic, combinatorial approach is necessary to have a significant impact on longevity and healthspan. The potential costs and scalability of gene therapies are discussed, with the speakers suggesting that plasmid-based therapies could potentially be manufactured at a low cost, similar to some vaccines, if the regulatory burden can be reduced.
The discussion concludes with a look at emerging initiatives like the "Right to Try" laws in Montana, which aim to provide more flexibility and access to experimental therapies within the United States. The speakers see this as a potential model for balancing innovation and patient safety.