Creative BioMolecules' OP-1 Slows Progress of Chronic Renal Failure in Preclinical Model of the Disease.

HOPKINTON, Mass.--(BW HealthWire)--Nov. 8, 1999--

Data Presented at the Annual Meeting of the

American Society of Nephrology 

Creative BioMolecules, Inc. (Nasdaq:CBMI) announced today new preclinical data which indicates that the administration of OP-1 offers advantages over the current standard of care for patients with chronic renal insufficiency. The study indicated that OP-1 reduced scar tissue formation in the kidneys, reduced damage to the tubular structure and preserved renal function. These new data further support the Company's development of an OP-1 therapy to treat chronic renal failure. The study was conducted by researchers at the Washington University School of Medicine in St. Louis and presented at the Annual Meeting of the American Society of Nephrology.

"The administration of OP-1 appears to provide an important advantage over ACE inhibitors, the current standard of care for renal insufficiency. While both OP-1 and ACE inhibitors were able to reduce fibrosis, only OP-1 preserved tubular structure. The ability to preserve tubular structure may help slow the progression of the disease and delay the need for dialysis treatment," commented Keith A. Hruska, MD, Professor of Medicine at the Barnes-Jewish Hospital of the Washington University School of Medicine.

"This study confirms the effect of OP-1 in an important model of chronic renal failure. Based on these data and previously reported preclinical studies, Creative expects to file an Investigational New Drug application with the U.S. Food and Drug Administration in the fourth quarter of 2000 to initiate a human clinical trial," said Carl M. Cohen, PhD, Vice President, Research and Development of Creative BioMolecules.

In the study, rats underwent a unilateral ureteral obstruction--a procedure causing progressive fibrosis and renal damage that closely mimics the kidney scaring which occurs in chronic renal failure. Animals in the study were treated with either a vehicle control, an ACE inhibitor, or OP-1. The study showed that animals treated with OP-1 experienced reduced fibrosis and had less damage to renal tubules where key absorptive events occur, than animals in the ACE inhibitor and control groups. In addition, OP-1-treated animals retained approximately 30 percent of their normal kidney filtration and approximately 65 percent of normal renal blood flow as compared to the vehicle and ACE inhibitor-treated animals in which there was no measurable return of filtration and blood flow. These data indicate that the administration of OP-1 preserves kidney function in a model of chronic renal failure.

Individuals affected by chronic renal failure experience a progressive decline in kidney function which leads to a toxic buildup of metabolic waste products in the blood. The most common causes are diabetes and high blood pressure. Sixty-thousand patients with chronic renal failure begin dialysis each year in the United States. Dialysis severely compromises a patient's quality of life and is estimated to cost the U.S. healthcare system close to $12 billion annually. ACE inhibitors, the current standard of care, help to control blood pressure and are commonly prescribed to slow the progression of renal failure.

Creative BioMolecules is a biopharmaceutical company developing therapies for human tissue repair and regeneration. The company is focused on morphogenic protein-based therapies to enhance stroke recovery and treat renal disease. Both applications are currently undergoing preclinical development, with the submission of INDs to begin clinical trials expected in 2000. The first product resulting from Creative BioMolecules' technology, the OP-1 Implant(TM) for orthopaedic reconstruction, is licensed to Stryker Corporation and is under regulatory review for approval in the U.S. and Europe.

This news release includes forward-looking statements that involve risks and uncertainties. Factors which could cause actual results to differ from the Company's expectations include, without limitation, preclinical demonstration of safety and efficacy in the renal field, the course of its preclinical and clinical development programs, including the achievement of development milestones by the Company and/or its partners, the initiation, progress and successful completion of human clinical testing, the timely receipt of regulatory approval required for clinical testing, manufacturing and marketing of products, the impact of competitive products, and the other risks and uncertainties detailed from time to time in the Company's periodic reports.

NOTE: For additional information, please consult Creative BioMolecules' homepage at http://www.creativebio.com.