New Orleans, LA, March 23, 1998—Creative BioMolecules, Inc. (NASDAQ: CBMI) and Stryker Corporation (NYSE: SYK) reported that Dr. George Muschler, Cleveland Clinic, presented at the American Academy of Orthopaedic Surgeons (AAOS) the analysis of the data in the clinical trial of the investigational OP-1 Device. The results demonstrated that the OP-1 Device group had comparable clinical success to the autograft group without the need for a second invasive procedure to harvest autograft bone from the hip.
Stryker and Creative BioMolecules are developing OP-1, a genetically engineered Bone Morphogenic Protein (BMP), for use as a bone graft material. The OP-1 Device is a combination of OP-1 and a resorbable collagen scaffold which is designed to be surgically implanted in bone fractures and defects. The protein activates a highly specialized bone cell reaction that induces normal bone regeneration.
The randomized prospective study included 122 patients at 18 different centers throughout the United States. Patients included in the study had tibial nonunion fractures for at least nine months following initial injury without demonstrating progress toward union for the previous three months. These fractures are usually caused by high-energy trauma, do not heal well, and generally require repeated surgical interventions. The study was designed to evaluate whether treatment with the OP-1 Device is equivalent to autograft, the current standard of treatment. Autograft uses bone chips removed from a patient’s hip in an additional operation.
According to Dr. Muschler, the analysis of the data showed statistical equivalence between OP-1 and autograft with respect to the clinically important areas of weight-bearing and pain, and that there were comparable rates of re-operation for the two groups of patients. There have been 10 OP-1 patients and 11 autograft patients re-operated to date. In addition, Dr. Muschler reported a significant reduction in blood loss for the OP-1 patients as compared to the autograft patients, and that the use of OP-1 eliminated other complications associated with the harvest of autograft.
There were three prospectively determined clinical trial outcomes defined in the study: weight-bearing; level of pain with weight-bearing; and radiographic assessment of cortical bridging. The study design predicted 80% success at 9 months post-surgery. Both the OP-1 and autograft groups met this predication for the clinical outcomes of weight-bearing and pain, and both groups had comparable results. The blinded radiographic assessment by an independent panel of radiologists showed that neither group achieved the predicted level of cortical bridging. The postoperative x-rays immediately following surgery showed a bias toward the autograft group because the transplanted autograft bone is radiodense, in contrast to the OP-1 Device which is transparent to x-rays. The radiographs improved for both groups at comparable rates throughout the 24 month follow-up period, however, radiographic assessment of the number of patients with cortical bridging remained approximately 10% higher for the autograft group. Dr. Muschler noted that there is no evidence in the data to suggest that the radiographic differences observed resulted in a difference in clinical return to function or increase in re-operation.
Papers on other OP-1 pre-clinical studies in spinal fusion, acute trauma, and cartilage regeneration were also presented at the AAOS and the accompanying meeting of the Orthopaedic Research Society.
Stryker Corporation develops, manufactures and markets specialty surgical and medical products, including orthopaedic implants, powered surgical instruments, endoscopic systems and patient care and handling equipment for the global market, and provides outpatient physical therapy services in the United States.
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.
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.
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