TEMPE, Ariz., Jan. 28, 2008 (PRIME NEWSWIRE) -- OrthoLogic Corp. (Nasdaq:OLGC) announced today that the U.S. Food and Drug Administration (FDA) has accepted an investigational new drug (IND) application for AZX100 in dermal/hypertrophic scarring. Phase 1 human clinical trials will begin during 1Q2008.
The clinical study will be a first-in-man Phase 1, randomized, placebo controlled, dose-escalation, single center study in which the safety and tolerability of escalating doses of AZX100 will be evaluated in healthy adult male subjects. A placebo control arm is included in this Phase 1 study for comparison of injection sites. Approximately 30 adult subjects will be enrolled at an experienced inpatient Phase 1 study clinic. The primary objective is to evaluate the initial safety and tolerability of AZX100 drug product in healthy adult subjects.
"We are pleased with the acceptance by FDA of our AZX100 IND application in dermal/hypertrophic scarring," said Randolph C. Steer, MD, Ph.D., President of OrthoLogic. "We had announced last year our goal of completing the IND filing by the end of fourth quarter 2007, and we met this milestone. The OrthoLogic scientific team assembled a high-quality IND package and responded to questions from FDA during the statutory 30-day post-filing period. We are now ready to proceed with our Phase 1 human clinical trial program."
Dermal scars result primarily from elective surgery (hospital and minor/office based), cosmetic, plastic and reconstructive surgery and trauma (including accidents, emergency and burns). Scars -- especially exuberant, hypertrophic scars -- can cause debilitating aesthetic, functional and psychological effects and remain a significant area of unmet medical need. Market research indicates there may be as many as 21 million procedures performed annually in the U.S. that could produce some form of scarring. There are currently no prescription drugs indicated for reduction of dermal scarring marketed in the U.S. or Europe.
About OrthoLogic
OrthoLogic is a biotechnology company committed to developing a pipeline of novel therapeutic peptides aimed at helping patients with under-served medical conditions. The Company is focused on development and commercialization of two product platforms: AZX100 and Chrysalin(r) (TP508).
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 and fibrosis. Based on its demonstrated effects in pre-clinical models, AZX100 is currently being evaluated for commercially significant medical applications such as the treatment of pulmonary disease, the prevention of hypertrophic and keloid scarring and intimal hyperplasia. OrthoLogic has an exclusive worldwide license to AZX100.
Chrysalin, the Company's novel synthetic 23-amino acid peptide, has been proven in multiple pre-clinical and clinical models to stimulate cellular events leading to angiogenesis, revascularization, and repair of dermal and musculoskeletal tissues. It is being studied in fracture repair, diabetic foot ulcer healing and disorders that involve vascular endothelial dysfunction. The Company owns exclusive worldwide rights to Chrysalin.
OrthoLogic's corporate headquarters are in Tempe, Arizona. For more information, please visit the Company's website: www.orthologic.com.