Libella Gene Therapeutics is looking to sell life-prolonging gene therapy. Her representative told about this to the portal OneZero. Patients will be injected with a viral vector with a telomerase gene. This experimental therapy will be part of a clinical trial, but will cost the participants a million dollars. Despite this, company representatives said that they already have two buyers and will receive their injections in the winter.
Telomeres are the ends of chromosomes that get smaller with each cell division. It is believed that their shortening is one of the causes of aging: cells in which telomeres have become shorter than a certain threshold lose their ability to divide and repair tissue damage. However, this process does not occur in all cells of the body: the enzyme telomerase works in the stem cells and tissues of the embryo, which builds on the ends of chromosomes and allows cells to divide longer.
Ever since this enzyme was discovered - and won the Nobel Prize for it in 2009 - researchers have been trying to use it to prolong life. In some cases, it even succeeded: for example, it turned out that if the telomerase gene is introduced to elderly (2 years old) mice, their average life expectancy increases by 13 percent, and the maximum - by 20.
Elisabeth Perisch, the first person on the planet who received an injection of a viral vector with the telomerase gene, advanced farthest on the path of mastering telomerase. Perisch founded her own company BioViva, which offers gene therapy to patients for old age, Alzheimer's disease, muscle weakness and kidney problems. However, until now, the company has not registered a single clinical study, and nothing is known about other patients who would have undergone therapy.
Meanwhile, a second company has appeared in the United States that plans to catch up and overtake Elizabeth Perisch - this is Libella Gene Therapeutics. Its representatives recently announced that they are launching their own clinical trial of a therapy that should operate on the same principle: a viral vector with a telomerase gene is injected into the patient's body. The trial is designed for three groups of participants: the elderly, patients with Alzheimer's disease and patients with limb ischemia.
Libella Gene Therapeutics invites clients to pay for the trial on their own: the cost of one course should be one million dollars. According to company representatives, two patients have already paid for the treatment: a 90-year-old woman and a 79-year-old man. By the second week of January, they will presumably have received their therapy.
Unlike BioViva, this company has registered its trial on the official US website clinicaltrials.gov. Nevertheless, the researchers plan to conduct it in Colombia, outside the jurisdiction of the American counterpart of the Ministry of Health (FDA), which, according to company representatives, would take too long to obtain approval for such a procedure.
This maneuver has already attracted the suspicion of critics on the company: the fact that the researchers are conducting their experiment outside the United States immediately suggests that they are afraid of control from the authorities, which means that they are not completely sure about the quality and effectiveness of their therapy. The fact that they registered their trial on an official resource does not add confidence to anyone as a result: the registration procedure is purely formal, and the therapy does not receive expert approval. Not so long ago, the American media reported that stem cell clinics were registering unverified treatments on the same site, thus giving the appearance of legitimacy. Finally, the hospital itself, which is planning to conduct experimental gene therapy, is not one of the largest in Colombia, and there are no more clinical trials registered there.
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However, questions arise not only about the quality and legitimacy of this test, but also about the method itself. So far, no evidence is known that telomerase can prolong human life. Elizabeth Perisch - the only one who could tell something about this - in 2018 (three years after the injection) announced that her telomeres became longer, which supposedly indicates a decrease in her biological age. In fact, the length of her telomeres is within the normal range, which means that it could have changed for other reasons, which sometimes occurs in humans.
But even if we assume that gene therapy really influenced Perisch's body, it is premature to draw any conclusions on this basis - this is an isolated case, which, moreover, has not been published in a peer-reviewed journal. And the same problem will appear, apparently, with the clients of Libella Gene Therapeutics - given the price they pay for the experiment, there will hardly be many of them, which means that these will also be isolated cases that do not confirm anything.
And the very idea of measuring biological age by the length of telomeres is now gradually losing popularity - at least, more and more works appear (here is an example) in which the authors fail to find a correlation between this parameter and the age of people. It seems that telomere length itself does not mean so much, but more important is the speed with which they shorten - among animals, for example, it is this parameter that correlates with lifespan.
The man listed on the company's website as Chief Scientist - William Andrews - already has several failed predictions. In 2016, he also worked with BioViva and announced the construction of a rejuvenation clinic on the island of Fiji, and in 2017, as part of Libella Gene Therapeutics, promised that telomerase trials "will begin in the coming weeks." Neither has happened yet.
Gene therapy itself looks like a promising method to combat if not aging in its purest form, then at least with age-related diseases. However, while any gene therapy remains a very expensive procedure, and in the USA, for example, a group of “biohackers” has even appeared who are trying to create a “pirated”, cheaper version of one of the most expensive drugs.
Polina Loseva