Looks like OP-1 has a good head start on this still in development product.
TEMPE, Ariz., Jan 18, 2001 (BW HealthWire) -- OrthoLogic Corp. (Nasdaq:OLGC) today announced that it has completed enrollment in its combined Phase I/II Investigational New Drug Application (INDA) clinical trial for Chrysalin, a synthetically manufactured peptide that has shown outstanding potential in pre-clinical animal studies to accelerate fracture healing.The randomized, double-blind, placebo-controlled study enrolled 90 patients withfresh distal radius fractures at seven clinical sites in the United States.The trial, designed to evaluate the safety and preliminary efficacy ofChrysalin, commenced enrollment in January 2000. Patients received a singleinjection of either Chrysalin or saline (placebo) at the time the fracture wasset. Each patient is then continually monitored to evaluate radiographic healingand several functional parameters.OrthoLogic reported that it expects to complete analysis of patient data and --data permitting -- submit an application for a Phase III clinical trial to theU.S. Food and Drug Administration (FDA) during the second half of 2001."The study has been underway for almost one year, and to date, there have beenno safety issues identified in the study group," said Dr. James Ryaby,OrthoLogic's vice president of research."Since the study is prospective and double-blind, there is no additional data toreport at this time," added Dr. Frank Magee, OrthoLogic's chief technologyofficer. "We do expect to break the study code and complete the data analysis by mid-year 2001 and, data permitting, submit an application for a Phase III trial during the second half of 2001."According to OrthoLogic's president and chief executive officer, Thomas R.Trotter, "Completion of the patient enrollment objective for this initial humanclinical trial of Chrysalin for fresh fracture repair is a very importantmilestone in our overall program to enter the exciting new osteobiologic marketfor orthopedic products. We are very pleased with the progress of this study todate and are moving forward with plans to begin a second program involvingChrysalin for spinal fusion repair before the end of 2001." About ChrysalinChrysalin represents a portion of the receptor-binding domain of the humanthrombin molecule, which is actively involved in the healing process for bothsoft tissue and bone. By mimicking specific attributes of the thrombin molecule,Chrysalin stimulates the body's natural healing processes, resulting inaccelerated tissue repair.Because Chrysalin is formulated as a minimally invasive, injectable product notrequiring a surgical procedure, OrthoLogic believes it could enjoy widespreadacceptance across a variety of orthopedic indications, including spinal fusion.In July 2000, OrthoLogic announced that the company had extended its licensingagreement with Chrysalis BioTechnology Inc. (www.chrysalisbio.com) for Chrysalinto include options for all orthopedic indications worldwide. Previously, thelicensing agreement between the companies included only the rights for fracturehealing indications in the United States.OrthoLogic develops, manufactures and markets proprietary, technologicallyadvanced orthopedic devices designed to promote the healing of musculoskeletaltissue. Founded in 1987, the company has headquarters in Tempe.For more information, visit the company's Web site: www.orthologic.com.
Jim |
