OP-1 is Critical Signaling Molecule in Kidney Development, Reports Proceedings of the National Academy of Sciences

Hopkinton, MA, August 20, 1996--Researchers at CreativeBioMolecules, Inc. (Nasdaq: CBMI), the National Institutes of Health and the School of Medicine of the University of Zagreb reported today on studies that show that OP-1 is a critical molecule involved in the formation of the kidney during early development. The data was published in the August 20, 1996 issue of the Proceedings of the National Academy of Sciences (PNAS) and is part of a larger body of research aimed at defining the potential role of OP-1 and other related morphogenic proteins in treating the progression of acute and chronic renal disorders.

"Research indicates that recovery from renal failure may involve repeating the process that occurs during embryonic kidney development," said Slobodan Vukicevic, M.D., Ph.D., Visiting Scientist at the National Institutes of Health and Professor at the School of Medicine, University of Zagreb, who is lead author of the paper. "Previous studies have shown that, in vivo, kidney glomeruli and tubules, the blood filtering structures in the kidney, form as a result of an interaction between two tissue types in the immature kidney. Our research demonstrates the OP-1 is the signal responsible for triggering this event."

Said Jeffrey B. Kopp, M.D., of the National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and an author, "The research is a key step in defining the molecular signals that underlie kidney development. Understanding the role of signaling molecules such as OP-1 may lead to new approaches to treating kidney diseases by mimicking the molecular events that occur in development."

"These studies, along with additional research by Creative and our academic collaborators, provide a strong rationale for evaluating OP-1 in renal failure," said Charles Cohen, Ph.D., Chief Scientific Officer of Creative BioMolecules. "The published research also provides additional evidence that OP-1 and related morphogens play a major role in tissue formation and provide a broad platform for developing therapeutics to restore damaged tissue." He noted that OP-1 is in pivotal clinical studies for use in orthopedic reconstruction and is being evaluated for use in neurological disorders, dental therapeutics and other indications.

Kidney formation occurs when undifferentiated embryonic tissue receives a signal from an adjoining tissue known as the ureteric bud. In this PNAS paper, researchers show in laboratory studies that OP-1 was a critical part of this signaling process. Researchers showed that OP-1 is produced in the ureteric bud at the precise time that differentiation into kidney tissue occurred. By substituting OP-1 for the ureteric bud tissue, the scientists stimulated the formation of normal kidney structures in cultured embryonic tissue. When the activity of OP-1 was blocked, these kidney structures failed to form. These findings suggest that OP-1 is both necessary and sufficient to either initiate or maintain kidney differentiation. Therefore, OP-1 is critical in the process of developing a mature kidney capable of filtering waste from the blood.

The authors of the published study, in addition to Drs. Vukicevic and Kopp, were Frank P. Luyten, M.D., Ph.D., of the National Institutes of Health and T. Kuber Sampath, Ph.D., of Creative BioMolecules.

In parallel with the kidney development studies, Creative BioMolecules and its academic collaborators have conducted animal studies to determine if the rapid onset of acute renal failure injury and the long-term deterioration of kidney function in chronic renal failure can be moderated by systemic administration of OP-1. Results of the initial acute studies, presented at a recent conference sponsored by the National Institutes of Health dedicated to acute renal failure, indicate that an OP-1 product can reduce the extent of injury to the kidneys in an animal model of acute renal failure.

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 Company’s 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 Company’s periodic reports.

Creative BioMolecules is a discovery and development company focused on proprietary protein-based therapeutics for human tissue regeneration and restoration. The Company’s 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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