TEMPE, Ariz., Dec. 10, 2008 (GLOBE NEWSWIRE) -- Capstone Therapeutics (Nasdaq:CAPS) announced today positive safety results were obtained in the second of two planned Phase 1 human clinical trials of AZX100 in dermal / hypertrophic scarring. No serious treatment-emergent adverse events were reported in any subject. Secondary outcomes indicated a statistically significant signal of pharmacological effect in favor of AZX100. The secondary parameters were included in this study for the purpose of evaluating efficacy measurements for future clinical trials.
Study Description
The AZX100 Phase 1b study was a six-week, placebo-controlled, single-center dose ranging study. The primary objectives were to evaluate safety and tolerability and to determine preliminary pharmacokinetics of AZX100 in healthy adult subjects undergoing elective skin punch biopsy. Among the secondary objectives were blinded histological and photographic assessments of the quality of wound healing. Forty subjects were treated; each served as their own control.
Study Results
* No serious treatment-emergent adverse events were reported in any subject. * Mild local erythema (redness of the skin) and local pruritis (itching) were the most common adverse events reported, along with several cases of mild-to-moderate injection site discomfort. * Collagen density at Week 6 showed a small but statistically significant improvement (p = 0.048) in the AZX100-treated group. * Alpha smooth muscle actin (a biological marker of myofibroblasts) was significantly increased (p less than 0.001 in the four higher doses, and p = 0.027 at the lowest dose) in the AZX100-treated group, and the effect appeared to be dose-dependent.
"We are pleased to announce the positive results achieved in our second AZX100 Phase 1 safety study in dermal scarring," said Randolph C. Steer, MD, Ph.D., President of Capstone. "This second study demonstrates an acceptable safety profile and clearly indicates a pharmacological effect of AZX100. These results validate both the pre-clinical effectiveness studies that guided and informed our decision to proceed with clinical trials of AZX100 in dermal scarring, as well as the first Phase 1 clinical safety study completed earlier this year. With the results to date, we have met our objectives to advance to Phase 2, which is planned for initiation during first quarter 2009."
About Capstone Therapeutics
Capstone Therapeutics (trade name of OrthoLogic Corp.) 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. Capstone 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.
Capstone's corporate headquarters are in Tempe, Arizona. For more information, please visit the Company's website: www.capstonethx.com.
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Statements in this press release or otherwise attributable to Capstone 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.
Editor's Note: This press release is also available under the Investors section of the Company's website at www.capstonethx.com.