January 20, 2016 - Fertilix® becomes the first male fertility supplement with supporting data published in Human Reproduction
January 20, 2016 - Princeton, NJ - The CellOxess team is proud to announce that the Fertilix® pre-clinical, in-vivo efficacy study results have been published in the prestigious journal “Human Reproduction”, a peer-reviewed scientific journal from University Oxford Press and is available here. The work has been well received by the scientific community and was recently featured by one of the top pharmaceutical news agencies, BioSpace and the University of Clermont.
This international study was a collaboration between CellOxess biotechnology in Princeton, NJ, and scientific advisors, Professor Joël Drevet from University of Clermont in France and Professor Alfonso Gutiérrez-Adán at Instituto Nacional de Investigaciones y Experiencias Agronomicas y Alimentaria (INIA) in Madrid. Sperm DNA damage is strongly associated with subfertility/infertility, higher rates of miscarriage, and the development of novel genetic mutations in the offspring’s DNA. Results from two different, independent mouse models of oxidative stress-induced male infertility demonstrated that Fertilix® indeed restores pregnancy rates to near normal levels with a simultaneous reduction of fetal resorption (equivalent to miscarriages in women). These positive results can be attributed to Fertilix protecting the sperm cells, and most importantly the DNA they carry, from oxidation during their development and subsequent storage.
CellOxess is now the only company in the male infertility sector which has generated comprehensive preclinical data to support the treatment efficacy of its product. We believe the results of our animal studies will translate to similar findings in infertile men as natural antioxidants are used by mammals in a similar way to humans and our findings establish Fertilix as the most superior male fertility formulation in the market.
This data provides a solid foundation for the advancement of Fertilix into human clinical studies in line with the standard product development process conducted in pharmaceutical industry. Even though formal clinical trials are not required for nutritional supplements, our intention is to generate conclusive human data by conducting an international, multicenter human clinical study. To avoid erroneous or chance findings by small studies as reported by several other competitors, CellOxess plans to recruit a minimum of 500 couples for its clinical research program.
CellOxess is proud of its research efforts in understanding, treating, and improving male reproductive health and will continue to drive progress in the field forward.
This international study was a collaboration between CellOxess biotechnology in Princeton, NJ, and scientific advisors, Professor Joël Drevet from University of Clermont in France and Professor Alfonso Gutiérrez-Adán at Instituto Nacional de Investigaciones y Experiencias Agronomicas y Alimentaria (INIA) in Madrid. Sperm DNA damage is strongly associated with subfertility/infertility, higher rates of miscarriage, and the development of novel genetic mutations in the offspring’s DNA. Results from two different, independent mouse models of oxidative stress-induced male infertility demonstrated that Fertilix® indeed restores pregnancy rates to near normal levels with a simultaneous reduction of fetal resorption (equivalent to miscarriages in women). These positive results can be attributed to Fertilix protecting the sperm cells, and most importantly the DNA they carry, from oxidation during their development and subsequent storage.
CellOxess is now the only company in the male infertility sector which has generated comprehensive preclinical data to support the treatment efficacy of its product. We believe the results of our animal studies will translate to similar findings in infertile men as natural antioxidants are used by mammals in a similar way to humans and our findings establish Fertilix as the most superior male fertility formulation in the market.
This data provides a solid foundation for the advancement of Fertilix into human clinical studies in line with the standard product development process conducted in pharmaceutical industry. Even though formal clinical trials are not required for nutritional supplements, our intention is to generate conclusive human data by conducting an international, multicenter human clinical study. To avoid erroneous or chance findings by small studies as reported by several other competitors, CellOxess plans to recruit a minimum of 500 couples for its clinical research program.
CellOxess is proud of its research efforts in understanding, treating, and improving male reproductive health and will continue to drive progress in the field forward.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
