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Biotech / Medical : CRIS, Curis (formerly CBMI) -- Ignore unavailable to you. Want to Upgrade?

To: wolfdog2 who wrote (228)	10/19/1999 9:05:00 AM
From: wolfdog2	Read Replies (1) \| Respond to of 668

Creative BioMolecules Focuses Operations on Advancing Products for Stroke and Renal Disease into Clinical Development HOPKINTON, Mass.--(BW HealthWire)--Oct. 19, 1999-- Company Channeling Funds from Early Stage Programs to Clinic-Directed Efforts Creative BioMolecules, Inc. (Nasdaq: CBMI) announced today that it has decided to focus its operational and financial resources on the development of its morphogenic protein-based clinical candidates for the treatment of stroke and renal disease. This redirected effort will make available several million dollars that were originally budgeted in 2000 to support discovery research programs and will result in a reduction of the Company's employee headcount from 70 to 43. This prioritization of effort was based on a thorough review of the preclinical data package developed for these indications. The Company expects to submit Investigational New Drug Applications (INDs) to begin clinical trials both in stroke and renal disease in 2000. The first product to emerge from Creative's morphogenic protein technology, the OP-1 Implant(tm), is under regulatory review for marketing approval in the U.S. and Europe. The OP-1 Implant(tm) is licensed to Stryker Corporation and is the first among a family of products for use in a variety of orthopaedic and dental indications. This reprioritization will have no impact on the orthopaedic and dental programs which are independently financed by Stryker. "We expect that reaching the clinic and generating human data in stroke and renal disease will provide a significant opportunity for increasing shareholder value," said Michael M. Tarnow, President and CEO of Creative BioMolecules. "Over the past year, our confidence in the clinical potential of both programs has increased, as we have developed additional preclinical data and reviewed the programs with leading experts in the stroke and renal disease fields. Moving forward we have a core internal team and key outside advisors in place with the expertise to complete preclinical and initiate clinical development." Mr. Tarnow noted the Company's cash reserves are sufficient to advance both indications into clinical trials. Creative is developing an innovative approach to stroke by focusing on the enhancement of motor skill recovery following the stroke event. Over the past year, Creative and collaborators at leading academic institution have completed preclinical studies in two new stroke recovery models. These new studies extend previously reported data and confirm that the administration of OP-1 results in improved motor skill recovery following animal models of stroke. Based on the promise of this new data, and previously reported preclinical studies, Creative is preparing to file an IND application with the U.S. Food and Drug Administration (FDA) in third quarter of 2000. Results have been equally encouraging in the Company's renal program. Previously reported preclinical studies have indicated the ability of OP-1 to stabilize renal function in models of acute and chronic renal failure. Over the past nine months, the Company and its academic collaborators at the Washington University Medical Center of St-Louis and Beth Israel Deaconess Medical Center of Boston, have completed new preclinical studies that extend the Company's knowledge of the efficacy of OP-1 in this important therapeutic area. In these studies, OP-1 stabilized kidney function, reduced fibrosis and preserved kidney structure in animal models of chronic renal failure. The protein has been well tolerated in preclinical studies and has demonstrated a favorable systemic safety profile. These studies have confirmed efficacy in preclinical models of renal failure and lead the Company towards filing an IND application with the U.S. FDA in the fourth quarter of 2000. 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, the course of its preclinical and clinical development programs, including the achievement of clinical 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 on the World Wide Web at creativebio.com. CONTACT: Creative BioMolecules, Inc. Karla MacDonald, (617) 912-2953