TEMPE, Ariz., Aug. 14, 2008 (PRIME NEWSWIRE) -- OrthoLogic Corp. (Nasdaq:OLGC) announced today the completion of dosing for its second AZX100 Phase 1 human clinical trial in dermal/hypertrophic scarring. Patient follow-up is ongoing.
The clinical study is a Phase 1b placebo-controlled, single-center dose ranging study. The primary objectives are to evaluate safety and tolerability and to determine preliminary pharmacokinetics of AZX100 in healthy adult subjects undergoing elective skin punch biopsy. Forty subjects have been treated. Results are anticipated for internal analysis by year-end 2008.
"We are pleased that dosing has been completed in the second study for our AZX100 Phase 1 human clinical trial program in dermal scarring," said Randolph C. Steer, MD, Ph.D., President of OrthoLogic. "The goal of this program for AZX100 is to develop a safe and effective medication for an unmet market need. We had previously stated this Phase 1b study would begin during third quarter 2008, and with this announcement it should be clear we are on track with our announced timelines. Assuming successful completion of this second Phase 1 safety study, we anticipate initiating Phase 2 efficacy studies in this indication early in 2009."
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) (rusalatide acetate or 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 currently being evaluated in disorders that involve vascular endothelial dysfunction, such as acute myocardial infarction and chronic myocardial ischemia. 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.
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 product; affects on our stock price and liquidity if we are unable to meet the requirements for continued listing on the NASDAQ Global Market; 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, 2007, 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.