TEMPE, Ariz., May 8, 2008 (PRIME NEWSWIRE) -- OrthoLogic Corp. (Nasdaq:OLGC) announced today the completion of dosing and patient follow-up for its initial AZX100 Phase 1 human clinical trial in dermal/hypertrophic scarring.
The Safety Committee reviewing all safety-related aspects of the clinical trial was satisfied with the profile of AZX100. On this basis, OrthoLogic plans to initiate its next Phase 1 human clinical trial of AZX100 in dermal/hypertrophic scarring during the third quarter of 2008.
The clinical trial described today was 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 were evaluated in healthy adult male subjects. A placebo control arm was included in this Phase 1 study for comparison of injection sites. Thirty adult subjects were enrolled at an experienced inpatient Phase 1 study clinic.
The next Phase 1 human clinical trial of AZX100 in dermal/hypertrophic scarring, to be initiated during the third quarter of 2008, will be a placebo-controlled, single-center dose ranging study to evaluate the safety and preliminary pharmacokinetics of AZX100 in healthy adult subjects undergoing elective skin punch biopsy. Approximately 40 adult subjects will be enrolled at an experienced Phase 1 clinic. Preliminary results are anticipated for internal analysis by year-end 2008.
"We are quite pleased with our progress in the AZX100 Phase 1 dermal scarring program," said Randolph C. Steer, MD, Ph.D., President of OrthoLogic. "The goal of this AZX100 program is to develop a safe and effective medication for a significant unmet market need, and we are on track with announced timelines. Our next step is to move forward with our second planned Phase 1 clinical trial."
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 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 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.