In vitro and in vivo analysis will be conducted to determine efficacy and mechanism of action.

Mount Sinai School of Medicine entered a research collaboration to evaluate Pro-Pharmaceuticals’ antifibrotic preclinical compounds. Previous experiments have shown that these Galectin-targeting polysaccharide molecules reverse the formation of fibrotic tissue in diseased rat livers.

Scott L. Friedman, M.D., division director of liver diseases at Mount Sinai, will test several of the company’s galactomannans and rhamnogalacturonans as Galectin blockers in liver antifibrotic therapies. Specifically, Dr. Friedman will complete the in vitro and in vivo analysis to assess fibrosis, fibrogenic gene expression, and liver function with the aim of determining efficacy and mechanism of action.

The only current treatment for late-stage fibrosis, or cirrhosis, is a liver transplant. More than 25 million Americans are or have been afflicted with liver and biliary diseases, according to the American Liver Foundation.

“The need for an effective therapeutic solution for liver fibrosis is acute, and this innovative project would certainly be vital and could significantly advance treatment in this critical area,” remarks Dr. Friedman. “The efficacy and safety of Pro-Pharmaceuticals’ approach appears to be unique, and thus these studies should be of the highest priorities.”

Pro-Pharmaceuticals’ GR-series of drug candidates are being developed for fibrotic diseases. Carbohydrate polymers were synthesized and screened to inhibit collagen production in in vivo and in vitro fibrosis models. Uncontrolled collagen expression is a pathological process that occurs during the fibrotic process affecting various organs and leading to scar tissue.

In vitro data indicated a reversal of fibrosis markers. Animal studies conducted in October 2007 showed that the compounds reduced collagen expression and reversed liver fibrosis.

Pro-Pharmaceuticals has a research alliance with the Brigham and Women’s Hospital in Boston to evaluate the antifibrotic effects of these compounds to treat acute and chronic kidney disease. The company is also working with the University of California, Davis and Fudan University in Shanghai to conduct antifibrosis tests.

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