TEMPE, Ariz., April 4, 2011 (GLOBE NEWSWIRE) -- Capstone Therapeutics (Nasdaq:CAPS) (the "Company") today announced an update to the reporting schedule for twelve-month results from its AZX100 Phase 2a pilot clinical trial in surgical (trocar site) scarring.
Due to the size and complexity of the dataset, the report has been delayed beyond the Company's originally-projected end-of-first quarter 2011 announcement date.
The Company will report these results as soon as practicable.
AZX100 Phase 2a in Surgical (Trocar Site) Scarring
The Company conducted a pilot Phase 2a clinical trial of AZX100 in surgical (trocar site) scarring (OL-ASCAR-03); this was a double-blind, placebo within-patient controlled, multi-center dose ranging study to evaluate the safety and preliminary efficacy of AZX100 (3.0 mg or 10.0 mg versus placebo) in trocar site scars of subjects who have undergone arthroscopic shoulder surgery. In this trial, AZX100 (or placebo) was administered on Days 9 and 21 following surgery, with no additional dosing throughout the remainder of the trial. One hundred fifty subjects were dosed in the trocar site scarring trial.
Pre-specified endpoints of these studies included evaluations of safety and efficacy of AZX100 based on the subjective primary endpoint Patient and Observer Scar Assessment Scales (POSAS) and objective secondary endpoints analyzed using 2D and 3D high-resolution digital photography. These endpoints included blinded, independently-scored Visual Analog Scales (VAS) and objective measurements of scar dimensions.
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 certain 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 Rights or ongoing Qui Tam Litigation 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, 2010, 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 .
CONTACT: Karen Struck, Investor Relations (602) 286-5250 firstname.lastname@example.org Lauren Glaser --The Trout Group (415) 392-3310 email@example.com
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