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CLINICAL DEVELOPMENT
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GEM 21S has been approved in the US by the FDA and in Canada by Health Canada for the treatment of bone defects and gingival tissue recession associated with advanced periodontal disease. GEM 21S combines recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) with Beta-tricalcium phosphate (β-TCP). The β-TCP physically fills bone defects providing a biocompatible scaffold or matrix that facilitates new bone formation while the rhPDGF-BB actively promotes the in-growth of new bone into the treatment site and stimulates cell proliferation to support bone tissue growth.
Luitpold Pharmaceuticals recently purchased BioMimetic's dental business, including the downstream formulation, fill and finish manufacturing rights of GEM 21S. However, the FDA and Health Canada approvals of GEM 21S as a grafting material for bone and periodontal regeneration laid the groundwork for the future of BioMimetic and provided the proof of concept needed to establish the safety and efficacy and regulatory pathway for the Company's platform technology. This success has greatly facilitated the development of BioMimetic's orthopedic product candidates GEM OS1 and GEM OS2.
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Continued Clinical Success with rhPDGF
BioMimetic released clinical data demonstrating that the Growth-factor Enhanced Matrix (GEM) technology has stimulated bone regeneration in four human clinical trials and in three anatomic sites, including the jaws, foot and ankle and distal radius (wrist).
For the clinical development of GEM 21S, BioMimetic conducted a 180 patient double-blind, randomized controlled trial to evaluate the safety and efficacy of GEM 21S for the regeneration of bone and tissue in the treatment of periodontal defects.
The results of the study demonstrated that GEM 21S treatment led to statistically significant benefits in bone growth and healing of the periodontal bone defects compared to the control group that received the β-TCP alone, without the addition of the growth factor.
GEM OS Clinical Results
Building on the success of GEM 21S, BioMimetic is developing a pipeline of drug-device combination product candidates for a broad range of orthopedic clinical indications. The GEM OS family of product candidates is targeted to treat open fractures (GEM OS1), closed fractures (GEM OS2), and stimulate bone formation at sites of risk for fracture, such as the spine in individuals with osteoporosis (GEM OS2). In preclinical studies, local application of GEM OS to long bone fractures stimulated faster fracture repair than treatment with the bone substitute matrix alone. Further, preclinical studies demonstrated that rhPDGF-BB is able to stimulate increased bone growth throughout much of the skeleton, suggesting that it could have broad therapeutic utility in fracture repair.
BioMimetic has initiated three clinical pivotal (registration) trials to evaluate GEM OS1 Bone Graft for use in foot and ankle fusion procedures.
There are more than one million procedures performed annually in the United States involving fusions and corrective surgeries of the foot and ankle. The indications included as part of the U.S. GEM OS1 pivotal clinical study represent approximately 70,000 of this annual number. Foot and ankle fusion procedures are performed primarily in patients with severe osteoarthritis, who do not respond to more conservative treatments.
| | GEM OS1 implanted at fusion site |
In April 2007, the Company initiated a U.S. pivotal trial that wil enroll up to to 396 patients at up to 28 centers to compare GEM OS1 to autograft for the treatment of foot and ankle fusions. In addition to the U.S. study, the Company also has completed a three center 60 patient open-label clinical trial in Canada to evaluate GEM OS1 in foot and ankle fusion procedures. The results from this study demonstrated that 90% of the patients, which included a large percentage of high risk individuals, achieved a successful outcome based upon return to full weight-bearing and lack of need for revision surgery. Additionally, the Company has an ongoing study being conducted in the European Union to assess the safety and efficacy of GEM OS1 as a substitute for autograft in the treatment of foot and ankle fusions.
In an initial pilot study conducted in the U.S. assessing the use of GEM OS1 for the treatement of foot and ankle fusions, GEM OS1 showed comparable efficacy to autograft (ABG) with shorter procedure time, and less pain and morbidity. Further, there were no device related adverse events reported in this study. In a European pilot distal radius (wrist) fracture study, GEM OS1 demonstrated faster bone healing at the fracture site as measured by CT scans. Additionally, the product candidate proved to be safe, with no reported serious adverse events related to the device. Distal radius fractures are one of the world's most common fractures, especially in elderly individuals with osteoporosis.
The Company also advanced its second orthopedic product candidate, GEM OS2, into clinical development. The Company has initiated patient enrollment in two pilot studies, the first of these being a 20 patient trial in which GEM OS2 is being evaluated for safety and clinical utility in closed fractures of the distal radius when delivered using minimally invasive surgical techniques. A second study is being conducted in Canada to evaluate GEM OS2 for the treatment of foot and ankle fusions.
Further, BioMimetic has ongoing pre-clinical studies evaluating product candidates for the treatment of various sports injuries including those requiring cartilage, ligament or tendon repair. |
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Updates on the clinical development of BioMimetic Therapeutics' product candidates will be posted on this website as they become available.
Please contact BioMimetic Therapeutics if you are a patient or clinician seeking additional information about the clinical programs. |
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