BioViva

BioViva logo

BioViva is a Bainbridge Island, Washington-based biotechnology company developing treatments to slow the ageing process in humans.

History

BioViva was founded in 2015.[1] In early 2016, Sierra Sciences announced that they were working with BioViva to start a new medical tourism-based venture, BioViva FIJI, on Fiji and that they will be the first company to use gene therapy to treat biological aging in humans.[2] CEO Liz Parrish explained the reason for setting up in Fiji: "The current regulatory authorities have an outdated model that does not accommodate these new technologies."[3] In June 2016, government sources in Fiji denied knowledge of the venture.[4]

BioViva released data gathered post-therapy in 2016, claiming that independent testing by SpectraCell Laboratories had revealed Parrish's leukocyte telomere length had been extended from 6.71kb to 7.33kb, an amount they state is equivalent to a reversal of 20 years of telomere attrition. The company also released data suggesting an improvement in insulin sensitivity, an increase in muscle mass, a more favourable blood lipid profile and a reduction in C-reactive protein, a potent marker of inflammation.[5]

BioViva's CEO Liz Parrish appeared on Norwegian television in the program Trygdekontoret to discuss the use of gene and cell therapies to improve health in an aging population.[6] Parrish has also appeared on Australian network ABC's Lateline, discussing BioViva's development of therapies to treat biological ageing.[7]

Parrish appeared at WIRED Health 2017 in London to discuss BioViva's testing of gene therapies targeting hallmarks of the ageing process. Appearing in WIRED, Parrish stated, "The company was built essentially to prove these therapies work or not. Remember BioViva is not a research organisation. We are taking things like gene therapies and using them like technology."[8]

Response

Parrish's treatment, often labelled as self-experimentation, is highly controversial. As the requirements to progress to human trials had not started, the US Food and Drug Administration did not authorize Parrish's experiments. Parrish travelled to Colombia for the treatments.[9]

Some have criticised BioViva's release of data claiming an extension of Parrish's leukocyte telomeres following her therapy, suggesting that the aforementioned extension is within the error change for telomere measurements. Dr. Bradley Johnson, Associate Professor of Pathology and Lab Medicine at the University of Pennsylvania said, "Telomere length measurements typically have low precision, with variation in measurements of around 10 percent, which is in the range of the reported telomere lengthening apparently experienced by Elizabeth Parrish."[10]

Altering the genetic makeup of humans, or gene therapy, by lengthening telomeres has been described as dangerous, as the ageing process is poorly understood. The telomeres' function is to restrict the number of times a cell can divide (thereby multiplying) to suppress cancer. Duncan Baird, a professor of Cancer and Genetics at Cardiff University's School of Medicine states, "Meddling with a fundamentally important tumor-suppressive mechanism that has evolved in long-lived species like ours doesn't strike me as a particularly good idea."[9]

Timothy Caulfield, professor in the Faculty of Law and the School of Public Health at the University of Alberta, characterized BioViva's work as 'pseudoscience' and lacking scientific rigor. George M Martin, professor of pathology at the University of Washington had agreed to be an adviser to the company but resigned upon hearing about Parrish's self-experiments.[9]

Antonio Regalado, reporter for the MIT Technology Review states, "The experiment seems likely to be remembered as either a new low in medical quackery or, perhaps, the unlikely start of an era in which naive people receive genetic modifications not just to treat disease, but to reverse aging."[11]

Parrish's decision to be 'patient zero' and test the company's technology on herself in a personalised N=1 study has been both criticised and lauded. Dr. Lawrence Altman, author of "Who Goes First? The Story of Self-Experimentation in Medicine" has said, "N's of 1 have had their value through history, and will. But you're not going to license a drug based on an N-of-1."[12]

Science

BioViva's technology is based on preclinical research of inhibition of both the enzyme telomerase and myostatin.

Telomerase gene therapy utilizing an adeno-associated virus undertaken by María Blasco's group at the Spanish National Cancer Research Centre (CNIO), has demonstrated several beneficial effects and an increase in median lifespan of up to 24% in mice.[13] Discussing her team's research, Blasco has stated in discussion with The Scientist, "We demonstrated that AAV9-Tert gene therapy was sufficient to delay age-related pathologies and extend both median and maximum longevity in mice. Many pathologies were delayed, including cancer. Translating these results to human diseases (telomere syndromes or certain age-related diseases without effective treatments) may be of interest in the context of clinical trials approved by the corresponding regulatory agencies."[14]

Myostatin inhibition gene therapy, utilizing the gene follistatin (a known inhibitor of myostatin), has been tested in a phase 1/2 trial on 6 people, for Becker's muscular dystrophy. 4 of the 6 patients showed improvements in walking ability following application of the gene therapy, with some muscle growth especially in response to the higher dosage.[15]

References

  1. ↑ "Company Overview of BioViva USA Inc". Bloomberg. Retrieved November 14, 2016.
  2. ↑ Tayag, Yasmin (22 May 2016). "BioViva Plans an Age Reversal Clinic in Fiji as Medical Tourism Gets Weird". Retrieved 24 July 2016.
  3. ↑ Bainbridge, Bill (31 May 2016). "'Fountain of youth' clinic proposed for Fiji called into question by Australian expert". Retrieved 24 July 2016.
  4. ↑ Pratibha, Jyoti (8 June 2016). "Authorities Deny Anti-Ageing Clinic Being Set Up Here". Retrieved 31 July 2016.
  5. ↑ "Dual Gene Therapy Has Beneficial Effects On Blood Biomarkers And Muscle Composition". BioViva USA Inc™. Retrieved 2017-03-31.
  6. ↑ NRK TV - Se Trygdekontoret (in Norwegian), retrieved 2017-03-31
  7. ↑ "Interview: Liz Parrish". 2017-02-23. Retrieved 2017-03-31.
  8. ↑ Medeiros, João. "Ageing is a disease. Gene therapy could be the 'cure'". WIRED UK. Retrieved 2017-03-31.
  9. 1 2 3 Nicola Davis; Dara Mohammadi (24 July 2016). "Can this woman cure ageing with gene therapy?". www.theguardian.com. The Guardian. Retrieved 1 August 2016.
  10. ↑ "Liz Parrish Is Patient Zero in Her Own Anti-Aging Experiment - The Crux". The Crux. 2016-04-29. Retrieved 2017-03-31.
  11. ↑ Regalado, Antonio (14 October 2015). "A Tale of Do-It-Yourself Gene Therapy". www.technologyreview.com. MIT Technology Review. Retrieved 25 July 2016.
  12. ↑ "Biotech executives using themselves as human guinea pigs". STAT. 2016-07-07. Retrieved 2017-03-31.
  13. ↑ Bernardes de Jesus, Bruno; Vera, Elsa; Schneeberger, Kerstin; Tejera, Agueda M.; Ayuso, Eduard; Bosch, Fatima; Blasco, Maria A. (2012-08-01). "Telomerase gene therapy in adult and old mice delays aging and increases longevity without increasing cancer". EMBO Molecular Medicine. 4 (8): 691–704. doi:10.1002/emmm.201200245. ISSN 1757-4684. PMC 3494070. PMID 22585399.
  14. ↑ "First Data from Anti-Aging Gene Therapy | The Scientist Magazine®". The Scientist. Retrieved 2017-03-31.
  15. ↑ Mendell, Jerry R.; Sahenk, Zarife; Malik, Vinod; Gomez, Ana M.; Flanigan, Kevin M.; Lowes, Linda P.; Alfano, Lindsay N.; Berry, Katherine; Meadows, Eric (2015-01-01). "A phase 1/2a follistatin gene therapy trial for becker muscular dystrophy". Molecular Therapy: The Journal of the American Society of Gene Therapy. 23 (1): 192–201. doi:10.1038/mt.2014.200. ISSN 1525-0024. PMC 4426808. PMID 25322757.
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