TEMPE, Ariz., May 31, 2011 (GLOBE NEWSWIRE) -- Capstone Therapeutics (Nasdaq:CAPS) (the "Company") today announced a material transfer agreement with BiolineRx (Jerusalem) to develop Chrysalin (TP508) in pre-clinical models of acute myocardial infarction (AMI). The goal of these studies is to further demonstrate the potential cardiovascular benefit of TP508 in an additional large-species model, a regulatory prerequisite to advance the program through the IND process toward human clinical trials.
Capstone has previously announced the cardioprotective benefit of TP508 as demonstrated in a series of landmark pre-clinical studies. These studies, performed in the laboratory of Frank W. Sellke, MD, formerly Chief, Cardiothoracic Surgical Research, Division of Cardiothoracic Surgery, Beth Israel Deaconess Medical Center / Harvard Medical School, showed that TP508 extensively decreases myocardial injury when administered following a major ischemic insult. (This administration timing reflects the anticipated clinical scenario of a heart attack.) Endpoints of the study included infarct size, coronary microvessel function, myocardial function and apoptotic markers. Findings showing the beneficial effects of TP508 were consistent across multiple models of AMI and attendant conditions, including normal and elevated cholesterol levels as well as diabetes.
The Capstone-BiolineRx alliance consists of sequential examination of the acute and chronic effects of TP508, studying in this additional large-species model 1) the ability to reduce post-MI ischemic area at risk, and 2) the chronic impact on left ventricular function and remodeling.
Commentary
"We are pleased to be working with BiolineRx on the TP508 cardiovascular program," said Randolph C. Steer, MD, PhD, President of Capstone Therapeutics. "We believe the potential beneficial cardiovascular effects previously demonstrated with TP508 warrant its further development. BiolineRx brings to the program unsurpassed expertise and independent validation of the science."
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 and observed signals of efficacy 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 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.