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Uniflex® - Additional Human Clinical Studies

Unigen Pharmaceuticals sponsored a randomized, double-blind, placebo-controlled human clinical trial in persons with joint discomfort in 2003 in Montreal, Canada. Doses of Uniflex® daily were 250 mg and 500 mg in separate groups, and an active comparator group was included. WOMAC scores after 1, 2 and 3 months were measured. After one month, WOMAC joint comfort scores were improved by 39% in the 500 mg dose group, and by 52% after three months. The 250 mg dose group showed median improvements in WOMAC joint comfort scores of 30% after one month. After three months, 85% of subjects experienced improvements in joint function. These data led to the use of a loading dose (500 mg daily of Uniflex®), followed by maintenance with 250 mg Uniflex® daily for Move Free® Advanced. Thus, daily use of the amounts of Uniflex® in Move Free® Advanced were supported by human clinical data.

A human clinical study reported at the 2007 International Cartilage Repair Society World Congress comparing 1000 mg of a medical food version of Uniflex® daily to an active comparator for joint discomfort found significant results for improvement of WOMAC joint comfort scores (32%) after one month. Another study conducted at Charles University in Prague, Czech Republic administered 500 mg of a medical food version of Uniflex® daily for one month. Again, significant improvements in joint comfort and function were found. Importantly, reductions in free radical concentrations were reduced from baseline in serum and synovial fluid after one month, lending evidence for an in vivo antioxidant effect in joints for Uniflex®. Also, synovial fluid arachidonic acid levels increased, signifying less arachidonate was used for eicosanoid production, suggesting that Uniflex® mechanisms observed in vitro also apply in vivo. Both of these studies were reported as abstracts, and are pending publication. Also, three additional human clinical trials using a medical food version of Uniflex® have been registered on Clinicaltrials.gov, a service of the US National Institutes of Health.

Thus, additional human clinical studies using Uniflex® alone have consistently shown improvements in joint comfort and function. Furthermore, evidence for antioxidant and cell signaling mechanisms for protection of joints coincident with improvements in joint health have been reported for Uniflex®.

References

Levy 2007; Unigen 2005; Vecka 2008
THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION.
THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.