Hopkinton, MA, November 4, 1996--Creative BioMolecules, Inc. (Nasdaq: CBMI) and its collaborators announced today the presentation of results from two separate studies indicating that a morphogenic protein, OP-1, protects against kidney damage in rodent models of acute and chronic renal failure. Additional studies presented by Creative and its collaborators confirm the critical role of OP-1 in kidney development and tissue survival. Based on the results of these studies, which were presented at the American Society of Nephrology 29th Annual Meeting and Scientific Exposition in New Orleans, Creative is accelerating its program to develop OP-1 as a treatment for kidney failure.
"Our research with OP-1 represents a promising approach to preventing the damage caused by acute renal failure," said Joseph V. Bonventre, M.D., Ph.D., Associate Professor of Medicine at Harvard Medical School and Massachusetts General Hospital. "In our rat model, administration of OP-1 provided significant protection against renal damage as determined by measuring markersof renal function." In studies done by other collaborators in a more severe model of acute renal injury, there was a significant reduction in mortality rate with OP-1 administration.
"In a chronic renal failure model, the results of our studies suggest that OP-1 plays a role in tissue survival and morphogenesis. OP-1 may provide a basis for the treatment of chronic renal disease," said Slobodan Vukicevic, M.D., Ph.D., Visiting Scientist at the National Institutes of Health. "In these statistically significant studies, systemically administered OP-1 demonstrated the ability to halt the progression of renal dysfunction in our rat model. The OP-1 treated group also exhibited statistically significant increase in survival rate as compared with the control group."
"The data from these studies provide strong evidence for the potential application of OP-1 in treating kidney disease and confirm our previous observations," said Charles Cohen, Ph.D., Chief Scientific Officer of Creative BioMolecules. "The Company has expanded the scope of its preclinical safety and efficacy studies to more fully evaluate the clinical promise of this compound. As our data have accumulated, we have seen great consistency of results showing the efficacy of OP-1 for both types of renal failure." He added, "Collectively, the data developed to date strongly suggest OP-1 and other morphogenic proteins may play an important role in the treatment of degenerative disorders."
Acute renal failure affects an estimated 250,000 people in the United States each year, and is characterized by the rapid and sudden loss of the kidneys' ability to filter blood. Acute kidney failure is often associated with multiple organ failure and a high mortality rate. A therapy which prevents, improves recovery or reduces the extent of kidney injury from acute renal failure would be a major medical advance. Chronic renal failure is a gradual and progressive loss of kidney function often associated with diabetes and high blood pressure and present in an estimated 700,000 people in the United States. Patients with chronic renal failure typically progress to end-stage renal disease, requiring dialysis or kidney transplantation. Recent research indicates that OP-1 is instrumental during the embryonic development of the kidney and that recovery from acute renal failure may involve repeating the processes that occur during embryonic kidney development. In one of the presented studies, scientists at Creative BioMolecules and the National Institutes of Health, led by Dr. Vukicevic, confirmed that OP-1 alone can induce kidney formation during embryonic development.
In another presented study, scientists at the University of Miami/Jackson Children's Hospital, led by Ana Paredes, M.D., Assistant Professor of Clinical Pediatrics, confirmed that following acute ischemic renal injury, OP-1 gene expression is severely downregulated, suggesting a role for OP-1 in natural kidney tissue survival. These and companion studies will help us better understand the mechanism by which OP-1 exerts its biological influence.
The statements in this news release that are not historical facts include forward-looking statements that involve risks and uncertainties. Factors which could cause actual results to differ from the Companys expectations include, without limitation, the achievement of product development milestones by the Company, the impact of competitive products, the timely receipt of regulatory clearances required for clinical testing, manufacturing and marketing of products and the other risks and uncertainties detailed from time to time in the Companys periodic reports.
Creative BioMolecules is a discovery and development company focused on proprietary protein-based therapeutics for human tissue regeneration and restoration. The Companys therapeutics are based on proteins that act as signals in initiating and regulating the cellular events involved in cell and tissue formation.
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