HOUSTON, May 29, 2019 — Rejenevie™ Therapeutics announced the start of its phase two clinical trial to study the safety and effectiveness of its proprietary AR-100 immune restoration therapy today. The therapy, which is administered at the Okyanos Center for Regenerative Medicine in Freeport, Bahamas, aims to address the declining capacity of the aging immune system through the use of rejuvenating factors from young blood cells. The Bahamian National Stem Cell Ethics Committee recently approved Rejenevie’s proposed trial protocol which will administer and monitor the treatment of up to 20 patients.
“The clinical trial has the potential to be a landmark study to determine if Rejenevie’s immune restoration therapy is the key to unlock, restore and strengthen the power of an aging immune system,” said Dr. Vincent Burton, President and Chief Anesthesiologist, Okyanos Center for Regenerative Medicine. “At the Okyanos Center, we are privileged to participate in the study to potentially help older individuals lead healthier and productive lives.”
During the Phase I clinical trial that concluded in February 2019, five patients received Rejenevie’s AR-100 immune restoration therapy to evaluate its safety in human patients. To date, no serious adverse events have been reported in any of the trial’s participants.
“We’ve been very pleased with the results in the patients who participated in the Phase I trial,” said Dr. Steven Greco, the Chief Science Officer of Rejenevie Therapeutics and Okyanos Global Health. “We found the majority of patients experienced an increase in natural killer cell function, which is a measure of our immune system’s ability to fight and kill cancer cells. We also noted an increase in the ratio of infection- and cancer-fighting immune cells compared to pro-inflammatory immune cells. Finally, and most impressively, we saw a dramatic decrease in the number of aging- and senescence-related genes expressed in the circulating immune cells of the patients.”
Prior to treatment, the patient’s stem cells will be transferred to the cGMP-certified Rejenevie laboratory at the Okyanos Center in Freeport to undergo a seven-day manufacturing process using Transwell technology.
In the Transwell system, two-chambers are separated by a nano-porous Transwell filter. The patient’s aged stem cells are placed in one chamber, while younger cells are put in the other. The cells interact but do not mix. The interaction allows young “factors” to penetrate the filter’s nano-pores to be absorbed into the aged stem cells.
Upon arrival at the Okyanos Center, the restored stem cells are delivered back into the patient through intravenous infusion in a process lasting approximately one hour. After the patient is discharged and returns home, he or she receives periodic blood testing over a 12-month period using a kit developed with one of the world’s leading diagnostics companies to ensure safety and to determine the therapy’s effectiveness.
“Our mission at Rejenevie is to give aging patients an improved quality of life and healthspan,” said Mark Benerofe, President and COO, Rejenevie Therapeutics and Okyanos Global Health. “With promising results observed in our Phase I trial and the potential of the Phase II study, we believe our science, methods and technology will give an aging world population hope to prevent or defeat a variety of age-related diseases.”
More About Rejenevie:
Rejenevie™ Therapeutics is a clinical-stage biotechnology company developing first-in-world immune restoration treatments that target age-related diseases. Based on the science of parabiosis, the company’s pioneering approach is focused on identifying factors found in the cells of young healthy individuals and using them to improve the function of aging stem cells and aging cells. Rejenevie™ plans to expand its therapeutic program beyond age-related immune restoration to treat specific types of cancer and infectious disease across all age groups.
More About Okyanos:
Okyanos is a regenerative medicine center of excellence that combines advanced technology, state-of-the-art equipment and a first-rate treatment team of expert physicians, nurses and technicians.