TEMPE, Ariz., Jan. 25, 2007 (PRIME NEWSWIRE) -- OrthoLogic Corp. (Nasdaq:OLGC) today announced that an article by Fife, et al entitled "Thrombin peptide Chrysalin(R) stimulates healing of diabetic foot ulcers in a placebo-controlled Phase I/II study" will appear in the January 2007 edition of Wound Repair and Regeneration. The randomized, double-blind, placebo-controlled study describes statistically and clinically significant results achieved with twice-weekly topical application of Chrysalin, combined with good wound care and standard off-loading, in subjects with chronic diabetic foot ulcers. The study was conducted by Chrysalis BioTechnology prior to its acquisition by OrthoLogic in 2004.
"We are pleased with the publication of these exciting results. The data provide additional confirming evidence of the biological activity of Chrysalin in tissue healing, and create new clinical development possibilities for the molecule," said Jock Holliman, Executive Chairman of OrthoLogic. "We are exploring potential partnership arrangements that will move Chrysalin toward approval in this indication."
About Diabetic Foot Ulcers
According to the American Diabetes Association, an estimated 20.8 million people, or 7% of the population, have diabetes. Within this group, the lifetime risk of developing a foot ulcer may be as high as 25%. In the U.S. alone, approximately 850,000 diabetic persons develop a foot ulcer each year. Chronic, non-healing diabetic wounds negatively impact quality of life and can increase the risk of infection and amputation; foot ulcers and their sequelae are also a major source of morbidity and resource utilization for persons with diabetes. Complications of diabetes account for more than 60% to 90% of all non-traumatic lower-limb amputations, and the International Diabetes Federation asserts that every 30 seconds a lower limb is lost to diabetes somewhere in the world.
About the Study
The potential safety and efficacy of TP508 (Chrysalin) treatment of diabetic foot ulcers was evaluated in a 60-subject, prospective, randomized, double-blind, placebo-controlled Phase 1/2 clinical trial. Chrysalin in saline or saline alone was applied topically, twice weekly, to diabetic ulcers with standardized care and off-loading. A dose-dependent trend was seen in the per-protocol population where 1 mcg and 10 mcg Chrysalin treatment resulted in 45% and 72% more subjects with complete healing than placebo treatment. Chrysalin treatment of foot ulcers showed statistically significant effects; twice-weekly application more than doubled the incidence of complete healing, increased mean closure rate approximately 80% and decreased the median time to 100% closure by approximately 40%. Chrysalin treatment of heel ulcers within this population resulted in mean closure rates 165% higher than placebo and complete healing in 86% (6/7) of ulcers compared with 0% (0/5) of placebo-treated ulcers. Local wound reactions and adverse events (AEs) were comparable between groups with no reported drug-related changes in laboratory tests or serious AEs.
"While there are many topical wound care products which support the body's natural (slow) healing processes, there are very few products that may be able to accelerate healing at the biochemical level. With this initial Chrysalin study, we may have made an important step toward harnessing the healing process through a simple-to-use agent that can be applied by an in-home provider," stated Caroline E. Fife, MD, Medical Director, Memorial Hermann Center for Wound Healing at the University of Texas Health Science Center in Houston.
"We are beginning to understand the molecular basis for the healing effects of this new drug," added Darrell H. Carney, Ph.D., Professor of Biochemistry and Molecular Biology at the University of Texas Medical Branch, Galveston. "We presented findings at the American Society for Cell Biology 46th Annual Meeting in San Diego, CA (December 9 - 13, 2006) that provide insight into how TP508 stimulates repair and revascularization of tissues. We believe that endothelial cells play a key role in a number of TP508 effects. Chrysalin appears to turn on a 'master switch' that may overcome the healing defects in these ulcers allowing them to heal and achieve complete re-epithelization."
About OrthoLogic
OrthoLogic is a biotechnology company committed to developing a pipeline of novel therapeutic peptides and other molecules aimed at helping patients with under-served medical conditions. The Company is focused on the development and commercialization of two product platforms: Chrysalin(R) (TP508) and AZX100.
Chrysalin, the Company's novel synthetic 23-amino acid peptide, is being studied in two lead indications, both of which represent areas of significant unmet medical need - fracture repair and diabetic foot ulcer healing. Based on the Company's pioneering scientific research of the natural healing cascade, OrthoLogic has become a leading company focused on bone and tissue repair. The Company owns exclusive worldwide rights to Chrysalin.
AZX100 is a novel synthetic pre-clinical 24-amino acid peptide, one of a new class of compounds in the field of smooth muscle relaxation called Intracellular Actin Relaxing Molecules, or ICARMs(TM). AZX100 is currently being evaluated for commercially significant medical applications, such as the treatment of vasospasm associated with subarachnoid hemorrhage, the prevention of keloid scarring and the treatment of asthma. OrthoLogic has an exclusive worldwide license to AZX100.
OrthoLogic's corporate office is in Tempe, Arizona. For more information, please visit the Company's website: www.orthologic.com.
Statements in this press release or otherwise attributable to OrthoLogic regarding our business that are not historical facts are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which include the timing and acceptability of FDA filings and the efficacy and marketability of potential products, involve risks and uncertainties that could cause actual results to differ materially from predicted results. These risks include: delays in obtaining or inability to obtain FDA, institutional review board or other regulatory approvals of pre-clinical or clinical testing; unfavorable outcomes in our pre-clinical and clinical testing; the development by others of competing technologies and therapeutics that may have greater efficacy or lower cost; delays in obtaining or inability to obtain FDA or other necessary regulatory approval of our products; our inability to successfully and cost effectively develop or outsource manufacturing and marketing of any products we are able to bring to market; changes in FDA or other regulations that affect our ability to obtain regulatory approval of our products, increase our manufacturing costs or limit our ability to market our products; our possible need for additional capital in the future to fund the continued development of our product candidates; and other factors discussed in our Form 10-K for the fiscal year ended December 31, 2005, and other documents we file with the Securities and Exchange Commission.
Editors' Note: This press release is also available under the Investors section of the Company's website at: www.orthologic.com.