Gene therapy research switches off joint inflammation; switches on genetic process of joint repair
Never before demonstrated approach now in clinical trial
CAMBRIDGE, MD. (Oct. 18, 2006) -- Scientists at Case Western Reserve University School of Medicine and Albany Medical College, together with Rainforest Nutritionals, Inc. have demonstrated in a mini symposium held today at the 14th International Conference of the Inflammation Research Association (IRA) that a blend of natural botanical products called Reparagen have turned on the master repair gene, IGF-1, which is responsible for growing human cartilage and restores joint function while blocking joint destruction associated with inflammation. The IRA is the preeminent meeting for inflammation investigators.
Mark J.S. Miller, Ph.D., M.B.A., Professor of Cardiovascular Sciences and Pediatrics at Albany Medical College (NY) and head of the Reparagen’s Scientific Advisory Board said that, "Sixty six million people have poor joint health; 20 million people suffer from osteoarthritis. Compromised joint health is a major contributor to comprised quality of life. No product of any kind has been able to demonstrate this combination of actions. These findings have been published in peer-review journals and presented to learned societies. The commercialization of Reparagen has been supported by the US government with a grant from the National Institutes of Health.
"Glucosamine is currently a gold standard in the natural product approach to joint health with $1 billion in annual sales but recent studies have questioned its effectiveness. There are no therapies on the market today that work by activating the genes that control the process of joint repair. Reparagen’s approach is unique, in that it switches ‘off’ the genes that control joint destruction and inflammation while turning ‘on’ the process of inserting glucosamine into new cartilage. Without this activated repair process glucosamine cannot be effective.1 So this solves a riddle that has plagued researchers for decades and corrects a problem that is exacerbated with aging.
Multi-center, Randomized controlled Clinical Trial Underway
Dr. Mark J.S. Miller said that, "This trial is important because it directly compares Reparagen with glucosamine in treating subjects with moderate osteoarthritis. Glucosamine is both familiar to consumers and healthcare providers and is the primary natural product approach to osteoarthritis."
The double blind randomized controlled clinical trial will assess a variety of pain, mobility and functional assessments in subjects with moderate osteoarthritis of the knee. Prior to this clinical investigation Reparagen was found to be the first natural product to "silence" genes that promote joint damage while simultaneously activating the repair gene, IGF-1, in human chondrocytes.2
The clinical study being conducted by clinical research organization Santerra Pharmaceuticals, LLC (www.santerra-pharma.com) was submitted to Current Controlled Trials for review of the protocol and assignment of an International Standardized Randomized Controlled Trial Number (ISRCTN25438351).3
Rainforest Nutritionals, Inc. Vice President Paul Bobrowski emphasized that, "Reparagen continues to set a new standard in the joint health market, emphasized by this clinical study and the Current Controlled Trials validation." Elaborating Bobrowski said, "We believe that Reparagen’s unique mechanism of action and its NIH innovation Award makes it the alternative to glucosamine or chondroitin that consumers can trust and try".
Coauthor Paul Bobrowski emphasized that "If joints are like a brick wall made from bricks of glucosamine, and then it makes sense that to rebuild a functional wall that you need the master bricklayer and not just the simple approach of getting more bricks." Elaborating Bobrowski said, "By activating the joints master bricklayer Reparagen offers a more effective approach for regaining joint health."
- The role of IGF-1 in joints is to improve the quality and quantity of cartilage and it does this by inserting glucosamine and related chemicals into the matrix. In inflammation this process is silenced preventing repair and for this reason responsiveness to glucosamine is highly variable. This research was published in the open access journal BMC Complementary & Alternative Medicine (http://www.biomedcentral.com/1472-6882/6/13).
- Both Santerra and Rainforest Nutritionals believe in the importance of exemplary science performed in open access manner and details of this 8 week clinical study in 80 subjects can be found at http://www.controlled-trials.com/ISRCTN25438351. Patients are taking Reparagen„µ orally with meals at the dose of 3 capsules of 600 mg a day.
The Inflammation Research Association is a non-profit organization instituted to bring together the world's top scientists and investigators with an interest in inflammation research, to encourage communication and discussion of scientific and technological advances that can be used to develop new therapeutic agents for the wide diversity of serious diseases with inflammatory processes.
EDITOR'S NOTE: An annotated background briefing document is available upon request.
About Park Labs, LLC
Founded in 2005, Park Labs is dedicated to bringing to market innovative approaches to health and unmet consumer needs. For more information see www.reparagen.com
About Rainforest Nutritionals, Inc
Founded in 2002, Rainforest Nutritionals, Inc. (www.rainforest-inc.com) is dedicated to the development of innovative natural therapeutics for the business-to-business market. Rainforest Nutritionals, Inc was awarded an Innovation Research Award (R43AG024733) from the NIH to foster the development and commercialization of Reparagen.
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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