TEMPE, Ariz., July 6, 2011 (GLOBE NEWSWIRE) -- Capstone Therapeutics (Nasdaq:CAPS) (the "Company") today announced results from a pre-clinical study of AZX100 in a rodent model of radiation-induced pulmonary fibrosis.
-
Using the TUNEL assay – an established method for detecting DNA fragments that are the hallmark of "programmed cell death" known as "apoptosis" – a significant decrease in apoptosis among all cell types was demonstrated with AZX100 treatment for 28 days compared to untreated lung (p = 0.00058).
-
Importantly, the TUNEL assay also showed with AZX100 treatment a significant decrease in apoptotic epithelial cells (p = 0.003). This effect translated to a greater than 70% decrease in apoptotic epithelial cell count with AZX100 compared to the untreated cohort. Preservation of normal epithelial cells is required for proper lung function.
- Using the hydroxyproline assay for collagen assessment - a well-characterized and accepted method for biochemical evaluation of fibrosis - a trend toward decreased hydroxyproline content was observed after AZX100 treatment for 28 days (p = 0.067).
These data provide additional pre-clinical evidence supporting an anti-fibrotic effect of aerosolized AZX100 in lung tissue. Earlier studies in the bleomycin-induced model of pulmonary fibrosis showed that AZX100 treatment significantly reduced soluble and tissue collagen (p = <0.05) and inflammation (shown via significant decreases in TNF-alpha and TGF-beta, p = <0.05) at a 1 mg/kg single daily dose for 18 days. Treatment with AZX100 was also shown to modulate several pulmonary metabolic pathways‚ including circadian rhythm and cytoskeletal remodeling. (Data from these studies were presented at the American Thoracic Society International Conference, May-2011- Denver, CO.)
Study Description
The present study was performed at Lovelace Respiratory Research Institute (LRRI – Albuquerque, NM). The effect of aerosolized AZX100 treatment was investigated in a rodent model of radiation-induced pulmonary fibrosis; C57BL/6 mice were irradiated with 14 Gy X-ray delivered to the thorax only. Mice surviving to 20 weeks post-radiation were randomized to receive AZX100 by aerosol (daily, 1 mg/m3, 30 minutes) or served as untreated controls. Treatment was initiated at Week 21 and culminated at Week 25.
Commentary
"We are pleased with these results demonstrating a significant anti-apoptotic effect of aerosolized AZX100 treatment in the challenging model of radiation-induced pulmonary fibrosis," said Randolph C. Steer, MD, PhD, President of Capstone Therapeutics. "In addition, the results on hydroxyproline content following 28 days treatment add to the compelling evidence of an anti-fibrotic effect favoring AZX100 and suggest another potential development pathway. Pulmonary fibrosis is a devastating disease state affecting as many as 200,000 Americans; adequate treatments are still being investigated."
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.
The Capstone Therapeutics logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5429
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 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.