PipelineReview.com - Biotech News & Online Store - BioMimetic Therapeutics Initiates Enrollment in E.U. Registration Trial for GEM OS(R)1 Bone Graft; U.S. GEM OS1 Pivotal Study Protocol Amended to Allow Shorter Follow-Up Time and More Patients

BioMimetic Therapeutics Initiates Enrollment in E.U. Registration Trial for GEM OS(R)1 Bone Graft; U.S. GEM OS1 Pivotal Study Protocol Amended to Allow Shorter Follow-Up Time and More Patients

08 Jun 2007

BioMimetic Therapeutics, Inc. today announced that it has initiated enrollment in a registration (pivotal) study in the European Union to assess the safety and efficacy of GEM OS1 Bone Graft as a substitute for autograft in foot and ankle fusion procedures.

FRANKLIN, TN, USA | June 7, 2007 | BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced that it has initiated

enrollment in a registration (pivotal) study in the European Union (E.U.) to assess the safety and efficacy of GEM OS1 Bone Graft as a substitute for autograft in foot and ankle fusion procedures. The study, which is intended to support GEM OS1 product registration in the E.U., will enroll up to 125 patients at up to 10 clinical centers. The primary endpoint for the study will be fusion rates as measured by CT scan at nine months post surgery. The Company previously reported interim data from U.S. and Canadian clinical trials which demonstrated that fusion rates for GEM OS1 treated patients appeared to be at least comparable to patients treated with autograft taken from elsewhere in the patient's own body, but without the donor site pain and potential complications of harvesting autograft.

BMTI also announced today that it has received full approval from the Food and Drug Administration (FDA) for its U.S. pivotal study to evaluate GEM OS1 Bone Graft in foot and ankle fusions. The final study design requires a six month follow-up period for the primary endpoint, which is three months shorter than previously announced. Patient enrollment will increase from the initially approved 280 patients to 396 patients, with the permitted number of clinical centers increasing from up to 18 to up to 28 to facilitate patient enrollment. As announced previously, the study is designed as a randomized controlled non-inferiority trial comparing GEM OS1 to autograft, with the two treatments randomized 2:1, respectively. The primary study endpoint is a comparison between the two groups of the percent of patients fused as measured by CT scan at six months.

"We are pleased to have completed our discussions with the FDA and reached agreement on the final pivotal study design for GEM OS1 ," said Dr. Samuel E. Lynch, president and CEO of BioMimetic Therapeutics. "The new study design reduces the follow-up time for the primary endpoint while increasing the power of the study. An additional benefit is that we also now have an opportunity to show both non-inferiority and, potentially, superiority, although the latter is not required to satisfy our primary endpoint. We have initiated patient enrollment and already have 12 clinical centers activated for the U.S. study and expect to complete enrollment within the coming nine to 12 months."

GEM OS1
BioMimetic is developing GEM OS1 for use in open surgical treatment of fractures and bone fusions where the use of bone graft, a material used to augment bone healing, is indicated. GEM OS1 is designed to be placed directly into an open surgical site to stimulate bone regeneration. The combination of the two GEM OS1 components, recombinant human Platelet-Derived Growth Factor (rhPDGF) and Beta-tricalcium phosphate (Beta-TCP), is key to the product candidate's activities. rhPDGF is intended to provide the biological stimulus for tissue regeneration by stimulating the in-growth and proliferation of osteoblasts, cells responsible for the formation of bone, while Beta-TCP provides a framework or scaffold for new bone growth to occur.

Foot and Ankle Procedures
In the United States, an estimated 1 million procedures are performed annually involving fusions and corrective surgeries of the foot and ankle, including fracture fixation, joint fusions and corrective osteotomies. Many of these procedures will incorporate bone graft to encourage the bone healing process. Foot and ankle fusion procedures are primarily performed in patients with severe osteoarthritis who do not respond to more conservative treatments. In a fusion procedure, the joint space between adjacent bones is surgically prepared and treated with a graft material to stimulate a fusion, or permanent connection of the two bone ends. This connection eliminates the pain associated with the movement of the joint. Typically, foot and ankle fusions are performed with bone material harvested from the patient (i.e, autograft), which is obtained as the result of a second surgical procedure. Harvesting autograft has significant drawbacks, which include requiring a second surgical site to harvest the graft, pain and morbidity associated with the second surgery and inconsistent volume and quality of the bone material harvested. GEM OS1, which is being developed as a fully synthetic substitute for autograft, eliminates the need for this second surgery. In foot and ankle surgery, non-unions are a common post-operative complication. This suggests a clear need for novel therapies such as GEM OS1 to improve healing rates in foot and ankle fusion applications. The U.S. market for bone graft substitutes, which includes synthetics, allografts and growth factors, was estimated at $1.4 billion in 2006. This market is expected to grow as surgeons seek suitable alternatives to the harvesting of autologous bone, which is still the most frequently used form of bone graft.

About BioMimetic Therapeutics
BioMimetic Therapeutics, Inc. is developing and commercializing bio-active recombinant protein-device combination products for the healing of musculoskeletal injuries and disease, including orthopedic, periodontal, spine and sports injury applications. BioMimetic received marketing approval from the FDA for its first product, GEM 21S ®, as a grafting material for bone and periodontal regeneration following completion of human clinical trials, which demonstrated the safety and efficacy of its platform technology in this indication. Additionally, the Company has clinical trials ongoing with its product candidates GEM OS®1 and GEM OS®2 in multiple orthopedic bone healing indications including the treatment of foot and ankle fusions and the stimulation of healing of fractures of the arm. The Company's product and lead product candidates all combine recombinant protein therapeutics with tissue specific scaffolds to actively stimulate tissue healing and regeneration.

Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of BioMimetic. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. There are many important factors that could cause actual results to differ materially from those indicated in the forward-looking statements. BioMimetic's actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with the marketing of BioMimetic's product and product candidates, unproven preclinical and clinical development activities, regulatory oversight and approval, and other risks detailed in the company's filings with the Securities and Exchange Commission. Except as required by law, BioMimetic undertakes no responsibility for updating the information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise, or for changes made to this document by wire services or Internet services.

SOURCE: BioMimetic Therapeutics, Inc.

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