TEMPE, Ariz., July 14, 2009 (GLOBE NEWSWIRE) -- Capstone Therapeutics (Nasdaq:CAPS) announced today the completion of enrollment for the first of its two ongoing AZX100 Phase 2 pilot clinical trials in keloid scarring.
These Phase 2 pilot trials are blinded, placebo controlled, multicenter, parallel group dose ranging studies to evaluate the safety and preliminary efficacy of AZX100 following excision of keloid scars. The primary objective of the studies is to evaluate the efficacy of AZX100 based on the differences among dosage groups in Patient and Observer Scar Assessment Scale (POSAS) scores at 12 months. Secondary objectives include safety determination and evaluations of efficacy via validated scar assessment scales using both 2D and 3D digital photography. The original clinical trial plan specified thirty subjects for enrollment in a single AZX100 pilot keloid study. Based on recruitment success, sixty subjects have now been enrolled in the first clinical trial, and an additional sixty subjects are being recruited for the second keloid trial. Collectively, these studies will evaluate AZX100 versus placebo in up to 120 subjects across a range of four active dose groups in the prevention or reduction of keloid scars.
"We are pleased that enrollment is complete in the first AZX100 Phase 2 pilot clinical trial in keloid scarring," said Randolph C. Steer, MD, Ph.D., President of Capstone Therapeutics. "The accelerated response to our recruitment efforts provides additional evidence that keloid scars represent a challenging unmet medical need. We are planning to conduct, for internal purposes, an observational analysis of selected data during 1Q2010, and we remain on track with our timelines for final data delivery during 4Q2010."
Keloids are raised scars that -- unlike hypertrophic scars -- extend beyond the site of the original wound. They are caused by an overgrowth of fibrous tissue and can occur following surgery, burn or other skin injury. Keloid scars can grow for weeks, months or even years, and typically do not resolve with time. The excess tissue comprising both hypertrophic scars and keloids is estimated to occur in 5-15% of wounds, more frequently in populations with darker skin pigmentation. There is currently no prescription medication specifically labeled for treatment of keloid scars in the U.S. or Europe.
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 with effects on both 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, treatment of pulmonary fibrosis 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, U.S.A. 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 on our stock price and liquidity if we are unable to meet the requirements for continued listing on the NASDAQ Global 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, 2008, 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.