Botanisol LLC awarded NIH/NCCIM grant to develop a new anti-inflammatory and possible Non-Steroidal Anti-Inflammatory Drug (NSAID) replacement. Use of NSAIDs cause an epidemic of cardiovascular and gastrointestinal complications resulting in 17,000 deaths and cost the US healthcare system more than $2 billion annually in 2008.
At some point everyone suffers pain due to inflammation. Causes may be as benign as intense physical activity and age related osteoarthritis or due to systemic, chronic diseases like rheumatoid arthritis. The incidence of inflammatory disease, especially arthritis is rapidly increasing with the aging population. The significance is evident in the size of the global market for anti-inflammatory drugs that exceeds $60 billion. Three of the top five selling drugs in the world are biotechnology derived anti-inflammatories, known as biologic response modifiers (BRMs) (Humira, Enbrel and Remicade). At a somewhat more benign level, medicines used for pain management, which include steroids and opiates, exceed $22 billion.
The common treatment for moderate and acute inflammatory pain is one of 19 FDA approved drugs called non-steroidal anti-inflammatory drugs (NSAIDs for short). Examples are ibuprofen, Motrin, Aleve and Celebrex. Although a staggering $12 billion of NSAIDs are sold worldwide each year, they carry a high cost in medical complications. With 100,000 hospitalizations, 17,000 deaths and $2 billion in added healthcare costs in the US each year, it’s easy to see why many have termed NSAID use an epidemic. Only a month ago the FDA strengthened its’ warning about the dangers of NSAIDs in an announcement titled: “FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes.” This builds upon more than a decade of studies and reports linking use of NSAIDs to bleeding ulcers, kidney problems, stroke and heart attacks. Recent data indicate greatly increased risk for cardiovascular complications for those over 65.
Scottsdale based Botanisol believe it has a promising solution in a compound they call TAI-LCx. Early published research has shown it to be effective at reducing inflammation using biologic pathways different from traditional NSAIDs. According to P. Scott Waterhouse, Botanisol’s CEO and co-founder, “ TAI-LCx is a promising discovery because it reduces inflammation without affecting the COX-2 (cyclooxygenase) enzyme. COX-2 mediation is directly linked to the known cardiovasular adverse effects of NSAIDs.” The National Institutes of Health, National Center for Complementary and Integrative Medicine seem to agree that this Scottsdale start-up is onto something potentially significant. Botanisol was officially informed on August 9 of a competitive grant award that will fund three crucial development stages of TAI-LCx.
TAI-LCx was discovered at the University of Arizona through a multi-year NIH supported research program. Botanisol is the exclusive licensee of the patented technologies. Dr. David Gang, Botanisol’s Chief Science Officer will direct the new research from rented laboratories at Washington State University. Gang explained, “What we know about TAI-LCx is very encouraging. Through the grant we will learn a great deal more about its structure and effect on other inflammatory pathways. The expertise, support and facilities at WSU, especially the TIPL lab are ideal for us.”
Botanisol is a “big idea” company poised to make a big splash in the growing biosciences community in Arizona. According to Mr. Waterhouse, “TAI-LCx is the first of what we hope will be several viable drug leads generated by our innovative approach. I feel we have passed a stern test in gaining the confidence of the incredible scientific community at NIH/NCCIM.”
ABOUT Botanisol LLC:
Botanisol is a translational biopharmaceuticals company that advances discoveries by applying modern science to known bioactive constituents of plants. Our mission is to provide the product development pipelines of pharmaceutical and healthcare companies with more affordable and safer drugs and other healthcare products. We operate with a unique capital efficient, low-overhead business model intended to reduce discovery risk and deliver rapid asset turnover.
Scott Waterhouse, Chief Executive Officer
32531 N Scottsdale Rd, Suite 105, Scottsdale AZ 85266
FDA Warning: http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm
New England Journal of Medicine re deaths and hospitalizations:
NSAIDs versus War Casualties
Lancet re cardiovascular risk:
Journal of the American Medical Association re NSAIDs and Congestive Heart Failure