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McCool, RxBio Holdings team pursuing a second promising drug

By Tom Ballard, Director of Innovation and Entrepreneurial Initiatives, Pershing Yoakley & Associates, P.C.

There’s a great deal of activity underway in both divisions of RxBio Holdings, Inc., according to Shannon McCool, the company’s Chair and Chief Executive Officer (CEO).

We first profiled one of McCool’s efforts – the Rx100 drug – in a teknovation.biz post in May (http://www.teknovation.biz/2012/05/15/rxbios-shannon-mccool-non-traditional-commercialization-path/). It is being developed by the holding company’s RxBio division and is intended to treat or prevent death for those who experience high-dose radiation. The company won a two-year, up to $24 million grant from the Biomedical Advanced Research and Development Authority (BARDA) of the U. S. Department Health and Human Services in late 2011 to further develop the drug.

When we looped back with McCool several weeks ago, we learned that another new drug under development by the holding company’s other division – ED Laboratories, Inc. – also shows promise in the radiation exposure area even though that was not the initial focus.

Ryan Yates, RxBio’s Vice President for R & D, told us that he has spent years “trying to come-up with new anti-inflammatory drugs.” One of those used a natural product called Cat’s Claw extract. During an especially difficult personal experience with peptic ulcer disease, Yates decided to try Cat’s Claw and found that it cured his peptic ulcer.

Over the next few years, Yates, who is also a faculty member in the College of Pharmacy at the University of Tennessee Health Science Center (UTHSC), and colleague Duane Miller began using Cat’s Claw as a building block for new drugs.

“We had a natural product that was essentially non-toxic,” Yates said. As they explored various possibilities, one of the analogs that they developed became today’s EDL 2000. “In early studies, it appears that the compound protects normal cells but not those with cancer” and is very effective in protecting normal cells exposed to high doses of radiation.

“It is really promising,” Yates added.

For McCool, it’s another potential product and further validation of the collaboration that has been underway between RxBio Holdings and UTHSC.

“Rx100 is our lead compound, and EDL 2000 is the next one coming-up in line,” McCool said. “We’ve discovered that EDL has a real impact on radiation injury. It fits some nice niches that our other products, including Rx100, don’t fit,” citing inflammatory bowel disease and inflammatory diseases of the eye.

Rx100 is a drug, taken parenterally. EDL 2000, on the other hand, can be applied orally, internally, or applied directly to the skin as a “dermal nanoemulsion”.

“In a health emergency, the solution must be easily administered,” McCool said, adding that EDL 2000 is “clearly classified as a pre-clinical compound” that will take five to 10 years to fully develop. This sort of time frame is not surprising or challenging for the CEO who has spent his entire career in the pharmaceutical industry.

“We’re dealing with cutting edge technologies designed to address significant human challenges,” McCool says. “What I enjoy doing is plowing totally new ground and hitting home runs.”

Just as interest in Rx100 grew significantly after the Fukushima nuclear disaster in March 2011, so, too, has interest in EDL 2000 increased as a result of an abstract that Yates submitted to the American Association of Pharmaceutical Sciences (AAPS). More than 10,000 to 12,000 people attend the group’s annual meeting.

“Out of all of the compounds being looked at for the meeting, this one (EDL 2000) was selected to be in the final five or six,” McCool said. It was the one that was ultimately selected for pre-meeting pitches to media.

The AAPS visibility drew the attention of the National Institutes of Health (NIH) which asked Ryan to make a presentation at a recent meeting. As a result, McCool says that the “interest we are now getting from NIH is significant.”

All of the interest and the various possibilities are just fine for him.

“I’ve never worked harder than I’m working now,” McCool says, but he’s also mindful that he has two drug possibilities in the pipeline, and more on the way. He’s equally mindful of the U.S. Food and Drug Administration’s emergency authorization powers to quickly approve drugs “if a situation ever warranted it.”

“Rx100 and EDL 2000 might be fine candidates,” he says, quickly adding that he wants to have them as close to ready as possible if people need them.


Tom Ballard

By Tom Ballard, Chief Alliance Officer,
Pershing Yoakley & Associates. P.C.

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