In recent years, gene therapy has grown considerably. Several experimental treatments have emerged, and various clinical trials have been carried out with the aim of treating certain pathologies such as childhood blindness. While these procedures are generally highly controlled, some biopharmaceutical players prefer to operate outside of legal oversight. This is the case of BioViva, a biotechnology startup based in Mexico that has administered gene therapy to patients with dementia based on an experimental treatment that is neither approved nor controlled.
Elizabeth Parrish, CEO of a biotech start-up called BioViva, announced last month that six dementia patients have traveled to Mexico so the company can administer experimental anti-aging gene therapy to them at the shelter l watchful eye of the FDA. Parrish – who told STAT News that she had administered experimental gene therapy of her own design more than 100 times – indicates that dementia patients were recruited and treated in 2019 with a similar gene therapy experimental vector intended to extend telomeres.
” The power of the technology is there, we just can’t harness it because no one is able to raise the funds to bring these breakthrough regenerative drugs into clinical trials. Says Parrish. In his opinion, aging is a disease that requires treatment like any other. So she’s trying to revive the field of anti-aging treatments, which she says is getting heavier and burdened with unnecessary regulation.
Telomeres, genetic sequences located at the ends of chromosomes, are often used as an indicator of aging and cellular health because they gradually shorten over time, in which case cells lose their ability to replicate. This makes it a common target for longevity treatments – and according to Parrish, a target for reversing or delaying dementia and Alzheimer’s disease.
BioViva treatments: many unanswered questions
But when STAT investigated this particular startup and its alleged treatment, the newspaper left with more alarming questions than when it started. For example, BioViva worked with researchers to develop gene editing vectors for use in animals, but it is still unclear where and how they obtained human-focused vectors.
The fact that BioViva claims to have experimented with patients with dementia – a particularly vulnerable group – further complicates the problem, while deliberately avoiding regulatory oversight. Missing clinical data, sources circling in circles and contradictory reports call into question the validity and even the reality of the treatments, according to the STAT survey, which has experts in the field concerned. ” Everything I see indicates that the parties involved are not conducting a credible clinical trial with proper safeguards Says Leigh Turner, bioethicist at the University of Minnesota.
Renowned scientific consultants
BioViva relies in part on the presence of eminent scientists, including renowned Harvard geneticist and pioneer of genetic editing, George Church. But while Church said he provided BioViva with scientific information – and believed telomere treatments almost ready for humans – he had no idea the company was already experimenting on humans. .
” You don’t want academics at reputable institutions offering a protective function for what in many ways seems to be pretty disturbing activities on the part of these companies. So if he wants to lend his name to companies like this, he somehow becomes responsible by supporting them. Turner concludes.