TEMPE, Ariz., Feb. 10, 2009 (GLOBE NEWSWIRE) -- Capstone Therapeutics (Nasdaq:CAPS) announced today the initiation of dosing for its AZX100 Phase 2 clinical trial in dermal scarring.
The clinical trial is a Phase 2a double blind, placebo controlled, multi-center dose ranging study to evaluate the safety and preliminary efficacy of AZX100 in trocar sites of arthroscopic shoulder surgery patients. The primary objective is to evaluate the efficacy of AZX100 based on the differences among three 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. Approximately 150 patients are planned for treatment. An interim analysis is scheduled for late fourth quarter 2009.
"We are pleased that dosing has begun in the AZX100 Phase 2 clinical trial program in dermal scarring," said Randolph C. Steer, MD, Ph.D., President of Capstone Therapeutics. "Initiating the Phase 2 trial of AZX100 marks another development milestone for Capstone Therapeutics. We had previously stated this study would begin during first quarter 2009, and we remain on track with our timelines."
Dermal scars result primarily from elective surgery (hospital and minor/office based), cosmetic, plastic and reconstructive surgery and trauma (including accidents, emergency and burns). Scars -- especially exuberant, hypertrophic scars -- can cause debilitating aesthetic, functional and psychological effects and remain a significant area of unmet medical need. Market research indicates there may be as many as 21 million procedures performed annually in the U.S. that could produce some form of scarring. There are currently no prescription medications indicated for reduction of dermal scarring marketed in the U.S. or Europe.
As previously announced, Capstone Therapeutics management will host a conference call and webcast to discuss operating plans today at 4:30pm EST / 3:30pm CST / 2:30pm MST / 1:30pm PST. The call may be accessed at 888-256-9134 (domestic), (+1) 913-312-1387 (international); accompanying slides can be viewed by logging onto the Investors section of the Company's website, http://investor.capstonethx.com. A replay will be available beginning February 10, 2009 at 7:30pm EST until midnight February 18, 2009 and may be accessed at 888-203-1112 (domestic) or (+1) 719-457-0820 (international) with replay passcode 4407371.
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 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 disease 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.