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Local biotech moving potential cancer drug closer to market
May 9, 2018

Rapamycin Holdings Inc. expects it will soon get the clearance to conduct a first-in-human clinical trial for its novel drug at the UT Health San Antonio Mays Cancer Center.

By W. Scott Bailey – Senior Reporter, San Antonio Business Journal

Rapamycin Holdings Inc., a privately held drug development company based in San Antonio, has taken a critical step toward leveraging years of research into a marketable drug to fight cancer and other illnesses.

Rapamycin has submitted an investigational new drug, or IND, application with the U.S. Food and Drug Administration for the company’s pharmaceutical formulation of its eRapa compound. That application moves the Alamo City company closer to a planned Phase Ib clinical trial that could expedite the use of eRapa in patients with early-stage prostate cancer.

“Filing our IND is an inflection point for RHI,” Rapamycin President and CEO Dan Hargrove, said. “It allows us to start our first-in-human clinical trial.”

The FDA maneuver is years in the making. Rapamycin was established in 2012 and has a portfolio of several issued and pending patents for the use of its formulation of rapamycin to address dementia, cancer, autoimmune disease and postsurgical adhesions.

“Now, for the first time, we will see in what ways eRapa can help patients with cancer and how eRapa can rejuvenate the body’s immune system, especially in elderly patients,” Hargrove said.

There is a significant need for the treatment of early-stage prostate cancer, said Rapamycin officials, who note that therapeutic options range from active surveillance to aggressive radiation or surgical intervention. The company said its early evidence indicates there is a potential for eRapa to prevent the progression of prostate cancer in animal models, and that it could benefit early-stage human patients who are under active surveillance.

Rapamycin expects to soon launch the first-in-human clinical trial for early-stage prostate cancer at UT Health San Antonio’s Mays Cancer Center. Hargrove said significant collaboration among San Antonio organizations has helped put the company in this position.

“The leadership, scientists and clinicians at UT Health San Antonio and the Mays Cancer Center have been wonderful to work with,” he said.

Moving to market will likely require more capital. Rapamycin is seeking to close out its current $1.5 million convertible note.

“We are near the finish line,” Hargrove said.

Data from the Phase Ib clinical trial will provide necessary clues to the types of cancers that Rapamycin will look to target with eRapa.

“Our current thinking is that eRapa will be a potent drug to treat nonmuscle invasive bladder cancer. We are also exploring a handful of rare diseases that our preclinical studies indicate eRapa could treat,” Hargrove said. “The size of those Phase II trials will dictate the amount of money we will need to raise.”

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