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BIOHYL & OSTEOARTHRITIS

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BIOHYL

BioHyl™ is a patent pending, modified-hyaluronan biopolymer with superior oral absorption and bioavailability characteristics.   It is marketed as a branded dietary ingredient for systemic arthrosupplementation with supportive fundamental scientific and clinical research.  BioHyl is produced using microbial fermentation and contains no ingredients of animal origin.      

Increasing prevalence of joint pain

Joint pain occurs frequently in mammals.  The pain may be transient, acute, or chronic depending on its cause, i.e. trauma, overuse, inflammation, and osteoarthritis.  Mammals frequently develop referred pain in multiple areas due to altered gaits and compensation for load redistribution.

Risks of current osteoarthritis drugs

Currently the most common medications used to treat joint pain and osteoarthritis (OA) are Non-Steroidal Anti-inflammatory Drugs (NSAIDs).  They are pain relievers that reduce pain and swelling.  They are frequently prescribed or self-administered ad libitum.  Types include aspirin, ibuprophen, (Motrin, Advil, Nupron), and naproxen (Aleve, Naprosyn, Naprelan, Anaprox).  Although NSAIDs work well, long-term use of these drugs can cause stomach problems, such as ulcers and bleeding. In April 2005 the FDA asked manufacturers of NSAIDs to include a warning label on their product to alert users of an increased risk for cardiovascular events (heart attacks and strokes) and gastrointestinal bleeding (Dugowson et al. 2006).  Certain NSAIDs may also increase the risk of fractures (Wheeler and Batt 2005).

Other medications used to treat OA include COX-2 inhibitors (coxibs).  Coxibs block an inflammation-promoting enzyme called COX-2.  This class of drugs was initially believed to work as well as traditional NSAIDs, but with fewer stomach problems.  However, numerous reports of heart attacks and stroke have prompted the FDA to re-evaluate the risks and benefits of the COX-2s.  Rofecoxib (Vioxx) and valdecoxib (Bextra) have been withdrawn from the US market following reports of heart attacks in some patients taking the drugs.  Celecoxib (Celebrex) is still available, but labeled with strong warnings and a recommendation that it be prescribed at the lowest possible dose for the shortest duration possible. 

Steroids and artificial joint fluid (Synvisc, Hyalgan etc.) can be injected directly into the joint capsule to reduce pain and inflammation for up to six months but have attendant injection site risks and do not improve the underlying condition.    

BioHyl is Orally Absorbed and Active

Researchers at the London Health Sciences Center have shown in a placebo controlled study that oral administration of BioHyl™ leads to a change in the size distribution of hyaluronan in the plasma. Specifically, the proportion of hyaluronan that is high molecular weight -- anti-inflammatory -- is increased, and the proportion of hyaluronan that is low molecular weight -- pro-inflammatory -- is decreased. The fundamental mechanism underlying these findings remains to be elucidated, but the results are consistent with earlier studies showing similar benefits with injected hyaluronan.  This is the first controlled study of an oral biomacromolecule demonstrating an increase in circulating HMW hyaluronan. 
Hyaluronan plays a vital role in many biological processes such as tissue hydration, proteoglycan organization, cell differentiation, proliferation and angiogenesis.  Hyaluronan plays a fundamental role in tissue repair processes, especially in the first stages of the process of granulation tissue, by stabilizing the coagulation matrix and controlling its degradation, favoring the recruitment of inflammatory cells, such as polymorphonucleocytes and monocytes of mesenchymal cells such as fibroblasts and endothelial cells, and directing the subsequent migration of epithelial cells.     

References
Dugowson CE et al (2006). Phys Med Rehabil Clin N Am 17, 347.
Wheeler P and Batt ME (2005). Br J Sports Med 39, 65.

Compiled by G.D. McClure Jr., Ph.D., Chief Scientific Officer,
Cogent Solutions Group.

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