Michael M. Tarnow, President and CEO of Creative BioMolecules commented, "We are pleased with the recent encouraging preclinical results with OP-1 in renal failure. The development timeline for a chronic renal failure product now appears longer than first anticipated. With Biogens financial support and technical assistance, our internal renal team will work diligently over the coming months to move a chronic renal failure product toward the clinic. At the same time, we are evaluating the clinical opportunities for OP-1 in acute renal failure."
Creative BioMolecules decision to move forward with development of a therapy for chronic renal failure is based on the promising results of recently completed preclinical studies. Recent safety studies in primates have indicated a good systemic safety profile for OP-1, with no local or distal bone formation.
This news release includes forward-looking statements that involve risks and uncertainties. Factors which could cause actual results to differ from the Companys expectations include, without limitation, the course of the research and development programs, including the achievement of development and regulatory milestones by the Company, the timely receipt of regulatory clearances required for clinical testing, and completion of 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 has established a substantial proprietary position in the field of morphogenic proteins, including OP-1. The Companys morphogenic protein programs include a late stage development effort in orthopaedic reconstruction with Stryker Corporation as well as ongoing research to develop renal disease treatment with Biogen, Inc., and proprietary new therapies for stroke and other neurological disorders.
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