September 12, 2008
AZX100 Pre-Clinical Results Show Reduction of Fibrosis and Scarring; Human Clinical Safety Trials Continuing
TEMPE, Ariz., Sept. 12, 2008 (GLOBE NEWSWIRE) -- OrthoLogic Corp. (Nasdaq:OLGC) announced today the publication of positive results from pre-clinical studies of AZX100 in the management of excessive dermal scarring. There are approximately 21 million surgical procedures performed annually in the U.S. that can result in some form of dermal scarring.
The article presents several important findings about AZX100 and its potential use as a therapeutic agent in this application:
* The protein known as connective tissue growth factor (CTGF) has been implicated in the development of excessive scarring. In human cells stimulated with transforming growth factor beta 1 (a protein that regulates cell growth), AZX100 decreased the production of both CTGF and collagen compared to controls (p less than 0.05), suggesting its potential to minimize scar formation. * AZX100 also significantly decreased expression of CTGF and collagen caused by endothelin and lysophosphatidic acid (p less than 0.05), agents with known profibrotic properties. * In a well-characterized and accepted rodent model of dermal scarring, a single injection of AZX100 immediately following wound closure significantly improved both collagen fiber density (p less than 0.05) and collagen fiber maturity (p less than 0.05) compared to controls. These measurements are hallmarks of scar healing.
The study results are published in the Journal of Investigative Dermatology advance online publication 11-Sep-2008 (DOI: 10.1038/jid.2008.264). The abstract is available via the following link: http://www.nature.com/jid/journal/vaop/ncurrent/abs/jid2008264a.html.
"We are pleased to announce publication of these exciting pre-clinical data demonstrating the potential effectiveness of AZX100 in reducing excessive scarring," said Randolph C. Steer, MD, Ph.D., President of OrthoLogic. "These studies provided the scientific rationale for initiating our ongoing human clinical trial program in dermal scarring. As we have previously announced, our second Phase 1 40-subject clinical safety study is well underway; we have completed dosing of all cohorts and no serious treatment-emergent adverse events have been reported to date. Analysis and patient follow-up are continuing, and we expect to have data for internal analysis by year-end 2008. Assuming an acceptable safety profile, we anticipate initiating Phase 2 efficacy trials early in 2009."
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.
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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.
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CONTACT: OrthoLogic Corp. Investor Relations Karen Struck (602) 286-5250 [email protected] The Trout Group Lauren Glaser (415) 392-3310 [email protected]