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In Pharmapro Magazine

February 20, 2017

Botanisol featured in Pharmapro Pipeline Update: "TAI-LCx: A Botanical Alternative to NSAIDs?"

https://www.pharmpro.com/article/2015/10/pipeline-update-emergence-biosimilars-and-botanical-alternatives

Botanisol, LLC, was recently awarded an NIH/NCCIM grant to develop a new anti-inflammatory treatment that has the potential to replace non-steroidal anti-inflammatory drugs (NSAIDs)—which are known to have adverse effects on gastrointestinal and cardiovascular wellness. According to a 2002 report by the FDA, experts estimate that 103,000 individuals are hospitalized annually for serious NSAID-related gastrointestinal complications in the United States—with a cost exceeding two billion dollars. Since then, the statistics have either remained at similarly high levels or have continued to rise. According to Consumer Reports, the “Arthritis, Rheumatism, and Aging Medical Information System estimates that adverse effects due to NSAIDs are responsible for more than 100,000 hospitalizations and more than 16,000 deaths in the U.S. each year,” as of 2013. Furthermore, as of July, the FDA strengthened their existing warning label that NSAIDs increase the chance of heart attack or stroke.

With such a prominence of the adverse effects of NSAIDs, Botanisol has endeavored to find an alternative. Their product, TAI-LCx—which stands for turmeric anti-inflammatory–lipophilic compound, with the ‘x’ acting as a placeholder—is intended for anti-inflammatory use and pain management. Their R&D program is targeting development of an NSAID alternative as an over-the-counter drug.

Initial testing of TAI-LCx was done in comparison with indomethacin, specifically, which was one of the first NSAIDs on the market. Research found TAI-LCx to be similar in efficacy to indomethacin, and even more efficacious. Specifically, TAI-LCx has been shown in rheumatoid arthritis-induced rats to be at least as effective as indomethacin at reducing inflammation with a much better IC50 profile.

P. Scott Waterhouse, Chief Executive Officer of Botanisol LLC“TAI-LCx was discovered by a research group at the University of Arizona (Arizona Center for Phytomedicine Research) in 2005,” says Mr. P. Scott Waterhouse, Chief Executive Officer of Botanisol LLC. “There were eight NIH grants totaling $6.8 million from 2000 through 2004. The purpose of the research and grants was to find a non-COX anti-inflammatory treatment from a botanical source. The research focused on five different botanicals that were known historically to treat diseases, pain, and inflammation. They looked at the botanicals to determine how their anti-inflammatory properties were expressed and then isolated constituent(s) that reduced inflammation through a non-COX2 pathway.”

COX-1 is an enzyme that protects your gastrointestinal tract, while COX-2 protects the cardiovascular system—both of which are known to be negatively impacted by NSAIDs. TAI-LCx, on the other hand, was created with the purpose of avoiding the COX pathway entirely. “TAI-LCx has been shown to reduce inflammation in in vitro and rat studies,” says Waterhouse. “The initial research shows TAI-LCx reduces inflammation without mediating the COX2 enzyme. Therefore, it should avoid the cardiovascular adverse effects of the NSAIDs. It works downstream of COX on TNF-alpha, which is a leading and promising mechanism for a new anti-inflammatory medicine.”

“Our product does not mediate the COX-2 enzyme,” he clarifies. “We don’t have data to show that it doesn’t affect the COX-1 enzyme yet. That is part of what will be done in this next stage of research.” Botanisol was officially informed on August 9th of a competitive grant award that will fund three crucial development stages of TAI-LCx. These three stages, according to Waterhouse, are:

Developing a manufacturing process for doing the extraction and purifying the compound that is scalable to larger-scale production.

Extending studies of structure and biologic properties of variants to learn what the beginning compound looks like chemically.

Extending research into biologic pathways that the product affects.

“Given TAI-LCx’s mode of action, we think there is a possibility that it could end up being for chronic inflammatory diseases,” says Waterhouse. “At the current time, however, it seems a pretty clear it has great promise as a possible NSAID replacement.” Botanisol, a small company with an expertise in bioactive constituents of plants, has high expectations for TAI-LCs. “If we are successful, we will have a drug that doesn’t kill people or make them sick,” says Waterhouse. “Pure and simple.”

 

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