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Rapamycin Holdings, Inc. Opens First Human Clinical Trial of its eRapaTM Compound Targeting Early Stage Prostate Cancer

September 18, 2018

SAN ANTONIO--(BUSINESS WIRE)--Sep 18, 2018--Rapamycin Holdings, Inc. (RHI), a privately-held drug development company based in San Antonio, Texas, has treated its first human patient with the company’s pharmaceutical formulation of its eRapa TM compound. This first in human Phase 1b clinical trial of eRapa focuses on men with early stage prostate cancer.

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 eRapa TM

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.

About Rapamycin Holdings, Inc.

Rapamycin Holdings holds the exclusive licenses for Rapamycin-related research discoveries made at UT Health San Antonio. The company is leveraging a platform of Rapamycin-related discoveries which could have dramatic implications in improving an individual’s health-span and in fighting cancer as well as other age-related medical conditions.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the results of clinical studies and as to further development of eRapa for cancer. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with immune-oncology product development and clinical success thereof, uncertainties related to timing and ability to obtain needed shareholder consent in a timely manner, the uncertainty of regulatory approval, the uncertainty of partnering its clinical assets, and other risks and uncertainties affecting RHI and its development programs. Other risks and uncertainties of which RHI is not currently aware may also affect RHI’s forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. RHI undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

View source version on businesswire.com:https://www.businesswire.com/news/home/20180918005086/en/

CONTACT: for Rapamycin Holdings, Inc.

Lisa Owens, 210-601-6647

lisammowens@gmail.com

KEYWORD: UNITED STATES NORTH AMERICA TEXAS

INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS ONCOLOGY PHARMACEUTICAL RESEARCH SCIENCE

SOURCE: Rapamycin Holdings, Inc.

Copyright Business Wire 2018.

PUB: 09/18/2018 10:00 AM/DISC: 09/18/2018 10:01 AM

http://www.businesswire.com/news/home/20180918005086/en

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