A Revolution in Orthopaedics
Creative BioMolecules lead compound, the OP-1 bone graft device, has completed a pivotal clinical trial in the United States and is positioned to be the first commercial product developed using the Companys technology. The OP-1 device promotes new bone growth to heal severe fractures.
|Each year, in the United States alone, orthopaedic surgeons perform approximately 500,000 operations intended to promote the growth of bone with a bone graft. In a majority of these cases, surgeons use an autograft chips of the patients own bone which are harvested surgically, usually from the hip, then inserted into the fracture site or other sites where bone regrowth is needed. These chips contain naturally occurring proteins which promote healing of the fracture. Autograft is currently the gold standard of care for the repair of severe fractures including "non-union" fractures those which have not shown significant evidence of healing nine months following the injury.|
The OP-1 device delivers a recombinant form of a naturally occurring protein, osteogenic protein-1 (OP-1, also known as BMP-7), directly to the fracture site. OP-1 is a member of the family of bone morphogenetic proteins (BMPs), which activate a cascade of molecular events that induces normal bone regeneration. Use of the device obviates the need for the invasive autograft harvest procedure, thereby shortening surgical time and reducing blood loss, pain and the risk of infection.
Stryker Biotech (a division of Stryker Corporation), our partner for the OP-1 device, has completed a pivotal clinical trial designed to evaluate whether treatment with the OP-1 device is equivalent to autograft for healing severe fractures. The study included 122 patients at 18 different centers in the United States. Patients included in the study had tibial non-union fractures for at least nine months following initial injury without demonstrated progress toward union for the previous three months. These fractures usually are caused by high-energy trauma, do not heal well and, generally, require repeated surgical interventions.
A clinical investigator presented results of the trial in March 1998 at the Annual Meeting of the American Academy of Orthopaedic Surgeons. In the trial, the OP-1 device demonstrated clinical success in healing fractures which had not mended despite multiple prior surgeries.
The trial demonstrated statistical equivalence between the OP-1 device and autograft with respect to the clinically important areas of weight-bearing and pain. In this difficult patient population, clinical success exceeded 80 percent. As measured by re-operation rates, only 16 percent of the device group required re-operation as compared to 18 percent of the autograft group. Radiographic assessment indicated early differences, but showed comparable rates of bone formation during long-term follow-up. Use of the device in the trial eliminated the complications associated with the harvest of autograft bone, offering potential advantages including less pain, reduced risk of infection and reduced blood loss during surgery.
Additional Therapeutic Indications
Stryker is developing OP-1 products for other orthopaedic and dental indications. In addition to the pivotal trial in non-union fractures, Stryker recently initiated a 200-patient trial of the device in Canada for the treatment of acute fractures. Stryker also is conducting pilot clinical trials in Europe to explore additional orthopaedic applications.
OP-1 may be useful in the treatment of periodontal disease, representing a major market opportunity. Periodontal disease is a leading cause of tooth loss in adults. Several million procedures for the treatment of this disease are performed annually in the United States. Preclinical data presented during 1997 demonstrated that OP-1 promotes pronounced bone regeneration and repair of normal bone/tooth attachment structures in periodontal disease models. Based on these and other encouraging data, Stryker has initiated human trials of an OP-1-based therapy for periodontal disease.