On September 18, 2018 Rapamycin Holdings, Inc. (RHI), a privately-held drug development company based in San Antonio, Texas, reported that it has treated its first human patient with the company’s pharmaceutical formulation of its eRapaTM compound (Press release, Rapamycin Holdings, SEP 18, 2018, View Source [SID1234529479]). This first in human Phase 1b clinical trial of eRapa focuses on men with early stage prostate cancer.
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The trial will dose an expected twelve to 24 qualified patients to establish safety and explore the optimal biologic dose of eRapa. The trial is led by Michael Liss, M.D., a urologic oncologist at UT Health San Antonio MD Anderson Cancer Center, where the Phase 1b study is being conducted.
"This trial holds tremendous promise, not only for early stage prostate cancer patients but for many people with age-related diseases," commented RHI President and CEO, Dan Hargrove. "In addition to evaluating the safety and optimal dose of eRapa to potentially prevent the progression of prostate cancer, this trial will explore the ways in which eRapa can rejuvenate the body’s immune system, which is one of the strongest weapons against cancer. The final results will help signal our next clinical trials, as well as identify the various opportunities to explore to move eRapa toward becoming a platform therapy to alleviate a number of age-related diseases."
Dr. Liss, the principal investigator of the trial, said, "Early stage prostate cancer is a good target for eRapa because past research has shown that the compound has inhibited the growth of certain types of cancer cells. In this trial, men will be given eRapa in different doses to find the level that provides the biggest benefit with minimal side effects. The therapy has the potential to change how we manage men with early prostate cancer."
Dr. Ruben Mesa, director of UT Health San Antonio MD Anderson added, "This is a great example of the innovative clinical trials that are taking place here. Our cancer center has a long history of testing cancer breakthrough therapies in our world-renowned, early-phase cancer treatment program, the Institute for Drug Development. I am particularly excited about the potential of this new therapy to make an impact on early stage prostate cancer and possibly decrease the chance of recurrence."
RHI anticipates that the trial will conclude in mid 2019, leading the company closer to collaboration with the US FDA toward the expedited 505(b)(2) regulatory pathway. The company is also looking ahead to future clinical trials in potential indications that may expedite marketing authorization and commercialization of eRapa.
For information about participating in the study, please contact Allison Sherrill at (210) 567-1172.
About eRapaTM
Researchers at UT Health San Antonio discovered that an improved formulation of the well-known drug, Rapamycin, extended life span and health span in rodents by mitigating the effects of age-related diseases. Rapamycin Holdings, as the exclusive licensee of this technology, is capitalizing on this discovery by developing a novel proprietary and patented formulation for the treatment of serious unmet medical needs.