Capstone Therapeutics Announces Progress in Clinical Trials of AZX100 in Keloid Scarring
TEMPE, Ariz., Sept. 13, 2010 (GLOBE NEWSWIRE) -- Capstone Therapeutics (Nasdaq:CAPS) (the "Company") announced today that participating subjects have reached the planned twelve-month timepoint in the first of its two ongoing AZX100 Phase 2a clinical trials in keloid scarring. Data analysis for these subjects is underway. Per protocol and the original clinical development plan, results of the two keloid scarring trials will be pooled for analytical purposes and are scheduled for release during 4Q2010.
Capstone is conducting two Phase 2a clinical trials of AZX100 in reduction or prevention of keloid excisional scarring: OL-ASCAR-04, with dosing at 3.0 mg and 10.0 mg per linear cm (cohort completion to twelve-month timepoint announced today); and OL-ASCAR-05, with dosing at 0.3 mg and 1.0 mg per linear cm (trial continuing to its planned 12-month timepoint). These are blinded, placebo-controlled, multicenter, parallel group dose ranging studies to evaluate the safety and preliminary efficacy of AZX100 following excision of keloid scars. Endpoints of these studies include objective evaluations of safety and efficacy of AZX100 based on validated scar assessment scales as well as blinded independent clinical evaluations using high-resolution 3D digital photography. Fifty-nine subjects were dosed in each of the keloid scarring trials.
"We are pleased with our overall progress and with the low attrition rates in the clinical trials of AZX100 in keloid scarring," said Randolph C. Steer, MD, PhD, President of Capstone Therapeutics. "We designed these trials to guide and inform the clinical development of AZX100 in this challenging keloid scarring indication. As previously announced, we expect to report data from this set of trials during 4Q2010."
The Company is also conducting - with similar outcome measures - a Phase 2a clinical trial of AZX100 in trocar site scarring (OL-ASCAR-03); this is a double-blind, placebo within-patient controlled, multi-center dose ranging study to evaluate the safety and preliminary efficacy of AZX100 in trocar site scars of subjects who have undergone arthroscopic shoulder surgery. One hundred fifty subjects were dosed in the trocar site scarring trial. Data from this study are due 1Q2011.
About Capstone Therapeutics
Capstone Therapeutics 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 (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 and safety in clinical trials, AZX100 is currently being evaluated for commercially significant medical applications such as the prevention or reduction of hypertrophic and keloid scarring and treatment of pulmonary fibrosis. 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; effects of the Capstone Stockholder Put Right on our stock price, liquidity or our ability to continue operations; effects on our stock price and liquidity if we are unable to meet the requirements for continued listing on the Nasdaq Capital Market; our 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, 2009, 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.