Chrysalin Shown to Accelerate Fracture Healing in Pre-Clinical Animal Studies
Study Demonstrating Effectiveness of Thrombin-Like Peptide Presented at Annual Meeting of Orthopedic Surgeons
ORLANDO, Fla.--(BW HealthWire)--March 15, 2000-- OrthoLogic Corp. (Nasdaq:OLGC - news) today announced that results from a pre-clinical study show that Chrysalin(TM), an exciting potential product for the next generation of fracture healing treatments, accelerates healing in animal fracture models.
The study's authors conclude that the results demonstrate Chrysalin's potential for acceleration of fracture healing and bone repair in human clinical applications.
These findings were presented this week at the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) and the Orthopaedic Research Society (ORS) by James T. Ryaby, Ph.D., OrthoLogic's vice president of research, who co-authored the paper with seven colleagues.
``We believe that these pre-clinical findings have helped OrthoLogic move closer to entering the new world of `osteobiologics,' an entirely new generation of products for tissue and bone repair,' said Thomas R. Trotter, president and chief executive officer. ``These potential products accelerate the human body's own natural healing mechanisms to achieve success, and represent the future of orthopedics.'
Pre-Clinical Study Results
Thrombin receptors are expressed on all cells of the mesenchymal cell lineage, and during clot dissolution, thrombin fragments are released and act through these thrombin receptors to initiate the healing process. The purpose of this study was to determine the effects of a single percutaneous injection of Chrysalin, a synthetic 23-amino acid peptide representing a receptor-binding domain of human thrombin, on experimental fracture healing.
Closed femoral fractures were created in Sprague-Dawley rats (three and 10 months old, 12-15 animals/group). Chrysalin was injected percutaneously into the fracture site at concentrations of 1 and 10 micrograms/100 microliters. Mechanical assessment of fracture healing was performed by three-point bending or torsion testing.
Studies using three-month-old rats demonstrated statistically significant increases in mechanical strength with a single injection of Chrysalin. At two weeks, Chrysalin-treated fractures were more than 50% stronger than control fractures (p less than .001), this differential remained significant at four weeks, with a 40% increase in strength. In addition, the Chrysalin-treated fractures were as strong at four weeks as the control fractures were at six weeks.
In older rats, a significant effect on fracture healing at both three and four weeks post-fracture was observed, with increases of 31 and 36 percent, respectively (p less than .03). In soft tissue healing models, the thrombin peptide has been shown to increase 1) neutrophil accumulation and activation; 2) vascularization; and 3) collagen and matrix accumulation.
The study concluded that Chrysalin accelerates the rate of experimental fracture healing, which demonstrates the potential of the peptide for acceleration of fracture healing and bone repair in human clinical applications.
Human Clinical Trials Underway for Chrysalin
In January 1998, OrthoLogic acquired an equity stake in the start-up biotech firm Chrysalis BioTechnology Inc., based in Galveston, Texas. In late 1998, Chrysalis BioTechnology began a combined Phase I/II human trial to evaluate the application of Chrysalin for the treatment of chronic diabetic ulcers.
In January 2000, OrthoLogic began enrolling patients in a combined Phase I/II human clinical trial to evaluate the application of Chrysalin for the acceleration of fresh fracture healing. The trial consists of a prospective, randomized double-blind study of 90 patients in three clinical centers to evaluate the safety and preliminary efficacy of Chrysalin.
Patients will receive one injection of Chrysalin or placebo (saline solution) at the time the fracture is set and will be monitored weekly to evaluate healing. Depending on the rate of patient enrollment, OrthoLogic reported that the trial could be completed by the end of 2000.
OrthoLogic develops, manufactures and markets proprietary, technologically advanced orthopedic devices designed to promote the healing of musculoskeletal tissue. Founded in 1987, the company has headquarters in Tempe, Ariz.
For more information, visit the company's Web site: www.orthologic.com.
The statements in this news release regarding Chrysalin, the clinical trials and OrthoLogic Corp.'s possible development and sale of products are forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially. Factors that could cause or contribute to such differences include, but are not limited to, the effectiveness of Chrysalin in ongoing clinical trials, potential costs and delays related to the completion of the clinical trials or in obtaining requisite FDA approvals, timing of market introductions, higher-than-expected costs of production, other potential unknown problems with the production and marketing of products, and the company's dependence for sales on approval by third-party payers. The forward-looking statements should be considered in light of these risks and uncertainties. For a more complete description of the risks and uncertainties that face the company, see the company's annual report on Form 10-K for the fiscal year ended Dec. 31, 1998 and other documents filed by the company with the Securities and Exchange Commission.
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