Rejenevie™ Therapeutics Announces Start of AR-100 Trial

Rejenevie™ Therapeutics announced the commencement of the company's Phase II clinical trial to study the safety and effectiveness of its proprietary AR-100 immune restoration therapy to boost the function of the aging immune system. The clinical-stage biotechnology company develops first-in-world stem cell restoration treatments targeting age-related diseases.

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. Phase II trial participants will receive treatment at the Okyanos Center for Regenerative Medicine in Freeport, Bahamas.

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, Chief Science Officer, Rejenevie Therapeutics. "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."

As people age, the immune system's functions diminish increasing susceptibility to immune-related diseases, including cancer. The goal of the AR-100 clinical trial is to address the declining capacity of the aging immune system through a mixed-age (heterochronic) cell culture model to stimulate production of rejuvenation factors from young blood cells.

"Our mission at Rejenevie is to give aging patients an improved quality of life and healthspan," said Mark Benerofe, President and COO, Rejenevie Therapeutics. "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."

Patients participating in the Phase II clinical trial must be 55 years of age or older and determined to be in good health by a physician. Qualifying patients will have their blood stem cells mobilized, collected and cryopreserved within the United States.

"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."

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 global diagnostics company Quest Diagnostics to ensure safety and to determine the therapy's effectiveness.

Rejenevie plans to expand its cell-based therapeutic program beyond age-related diseases to include cell- and gene-based therapies to treat patients with certain types of cancer and infectious disease, among other potential indications.

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