SAN CLEMENTE, CA (November 6, 2007)— Metagenics, Inc., a leading developer and manufacturer of science-based medical foods and nutraceuticals sold through healthcare practitioners, today announced the publication of a scientific paper, “Clinical safety and efficacy of NG440: a novel combination of rho iso-alpha acids from hops, rosemary, and oleanolic acid for inflammatory conditions,” in the Canadian Journal of Physiology and Pharmacology, a publication of the National Research Council Canada.
The paper provides a detailed overview of the body of primary research conducted by Metagenics regarding NG440, an all-natural anti-inflammatory derived from hops.
Millions of people seek relief from minor pain and joint discomfort using conventional methods, but not without the possibility of adverse reactions. In their search for a safer, all-natural alternative, Metagenics researchers tested more than 200 natural compounds before discovering NG440. In vitro cell culture studies indicated that the primary ingredients of NG440—rho iso-alpha acids (RIAA) derived from hops (Humulus lupulus L.), rosemary extract (Rosmarinus officinalis), and oleanolic acid (Olea europa) derived from olive leaf—inhibit the formation of PGE2, a hormone-like chemical produced in response to inflammation and involved in the sensation of pain. Combined, as NG440, they selectively inhibit the pro-inflammatory activities of the COX-2 enzyme (release of PGE2) without affecting the maintenance activities of COX-2 (protection of the gastrointestinal lining, normal platelet function, and kidney blood flow).
In subsequent studies conducted at the Functional Medicine Research Center in Gig Harbor, Wash. (a Metagenics subsidiary), NG440 demonstrated a high degree of predicted safety in humans by having little or no impact on cardiovascular and gastrointestinal markers normally affected by selective COX-2 enzyme inhibitors, such as platelet function, blood pressure, blood cell count, or fecal calprotectin, a measure of gastrointestinal injury.
Highlights of this research include:
Safety. A study of 40 male and female mice administered NG440 orally for 22 days showed no adverse effects on body mass, food consumption, organ mass, ratio of organ mass to body mass, or gross or microscopic pathology, suggesting NG440 is a safe formula for human consumption.
Gastrointestinal function. In a 14-day clinical study in which subjects were treated with either NG440 or an equivalent dose of the non-steroidal anti-inflammatory drug (NSAID) indomethacin, it was found that NG440 resulted in no increase in intestinal inflammation whereas the NSAID in the same subjects did result in measurable increases in intestinal inflammation.
Platelet function. In a week-long clinical study in which subjects were treated in random order with a single dose of control (placebo), NG440 showed no effect on key markers of blood flow and vascular hemostasis, prostacyclin (PGI2) and thromboxane A2 (TXA2).
Blood coagulation. An open-label study of platelet function and blood coagulation after NG440 treatment showed no clinically relevant effect on prothrombin time (PT), a measure of blood coagulation.
Blood pressure. In an institutional review board (IRB)-approved human study of 50 subjects, NG440 demonstrated no significant changes in systolic or diastolic blood pressure.
Kidney, liver function. In an IRB-approved, 6-week, randomized, double-blind placebo-controlled study of 39 patients, NG440 showed no adverse effect on general chemistries, CBC, kidney, or liver function markers.
Clinical effectiveness. In an IRB-approved, 6-week, randomized, double-blind, placebo-controlled study of 39 patients, NG440 demonstrated significant influence on the reduction of pain scores related to joint discomfort.
“We believe NG440 may be a new class of therapeutic agent,” said Jeffrey S. Bland, PhD, Metagenics Chief Science Officer and President of the MetaProteomics® Nutrigenomics Research Center, “and that it may serve as a safe and efficacious alternative in some areas where specific COX-2 inhibitors have been traditionally used.”
About Metagenics, Inc.
Metagenics is a life sciences company and leading developer and manufacturer of science-based medical foods and nutraceuticals sold to healthcare practitioners worldwide. It is headquartered in San Clemente, CA, with manufacturing and research facilities located in Gig Harbor, WA, including the MetaProteomics® Nutrigenomics Research Center and the Functional Medicine Research CenterSM for human clinical research. Metagenics holds multiple proprietary formula patents and produces more than 400 research-based products to optimize health. The company demonstrates its commitment to purity and quality through its certifications for Good Manufacturing Practices ( GMP) from the NPA, NSF International, and TGA. For more information, please visit www.metagenics.com.
For further information or to arrange an interview with Dr. Bland, please contact: