Key Developments For Orthologic Corp.
Orthologic Corp. (CAPS.O) (Consolidated Issue listed on NASDAQ Capital Market)
Capstone Therapeutics Announces Chrysalin (TP508) Pre-Clinical Data
Capstone Therapeutics announced the presentation of pre-clinical data demonstrating significant benefit of Chrysalin (rusalatide acetate or TP508) in a model of acute heart disease and elevated cholesterol. The data demonstrate that Chrysalin, administered following the onset of ischemia, showed a statistically significant cardioprotective benefit in an elevated-cholesterol porcine model of acute myocardial infarction (AMI or heart attack). In this pathophysiologically relevant model of AMI with either normal (first cohort) or elevated cholesterol levels (second cohort), intravenous administration of Chrysalin produced a significant reduction in infarct size. Importantly, the drug was administered following ischemic insult, which reflects the anticipated clinical scenario of a heart attack. The key finding of this study is that TP508 provides significant, dose-dependent myocardial protection in the setting of hypercholesterolemia during ischemia reperfusion (IR) injury. TP508 administration led to a greater than 50% reduction of infarct size, improved regional left ventricular function, favored expression of cell survival proteins, and attenuated apoptosis. The portion of the study conducted in pigs with normal cholesterol demonstrated that TP508 decreases myocardial necrosis by 45%. Taken together, these data suggest TP508 may offer a novel approach in protecting the myocardium from IR injury.
Capstone Therapeutics Announces Positive Safety Results in Primary Endpoint From Second AZX100 Phase 1 Clinical Trial in Dermal Scarring; Pharmacologic Signal Shown in Secondary Endpoints
Capstone Therapeutics announced positive safety results were obtained in the second of two planned Phase 1 human clinical trials of AZX100 in dermal / hypertrophic scarring. No serious treatment-emergent adverse events were reported in any subject. Secondary outcomes indicated a statistically significant signal of pharmacological effect in favor of AZX100. The secondary parameters were included in this study for the purpose of evaluating efficacy measurements for future clinical trials. The Study Description: The AZX100 Phase 1b study was a six-week, placebo-controlled, single-center dose ranging study. The primary objectives were to evaluate safety and tolerability and to determine preliminary pharmacokinetics of AZX100 in healthy adult subjects undergoing elective skin punch biopsy. Among the secondary objectives were blinded histological and photographic assessments of the quality of wound healing. Forty subjects were treated; each served as their own control;No serious treatment-emergent adverse events were reported in any subject. Mild local erythema (redness of the skin) and local pruritis(itching) were the most common adverse events reported, along with several cases of mild-to-moderate injection site discomfort;Collagen density at Week 6 showed a small but statistically significant improvement (p = 0.048) in the AZX100-treated group.
OrthoLogic Corp. Announces Name Change
OrthoLogic Corp. announced that effective October 1, 2008, the Company will be known and doing business as Capstone Therapeutics. The new trading symbol on Nasdaq will be CAPS.
OrthoLogic Corp.'s Pre Clinical Results On AZX100 Show Reduction Of Fibrosis And Scarring
OrthoLogic Corp. announced positive results from pre-clinical studies of AZX100 in the management of excessive dermal scarring. There are approximately 21 million surgical procedures performed annually in the U.S. that can result in some form of dermal scarring. The article presents several important findings about AZX100 and its potential use as a therapeutic agent in this application: The protein known as connective tissue growth factor (CTGF) has been implicated in the development of excessive scarring. In human cells stimulated with transforming growth factor beta 1 (a protein that regulates cell growth), AZX100 decreased the production of both CTGF and collagen compared to controls (p less than 0.05), suggesting its potential to minimize scar formation; AZX100 also significantly decreased expression of CTGF and collagen caused by endothelin and lysophosphatidic acid (p less than 0.05), agents with known profibrotic properties; and In a well-characterized and accepted rodent model of dermal scarring, a single injection of AZX100 immediately following wound closure significantly improved both collagen fiber density (p less than 0.05) and collagen fiber maturity (p less than 0.05) compared to controls. These measurements are hallmarks of scar healing.
OrthoLogic Corp.'s Chrysalin (TP508) Demonstrates Significant Benefit in a Pre-Clinical Model of Acute Heart Disease
OrthoLogic Corp. announced that Chrysalin (rusalatide acetate or TP508), administered following the onset of ischemia, has shown a statistically significant benefit in a recently completed pre-clinical study designed to assess cardioprotective effects in a model of acute myocardial infarction (heart attack). Using a pathophysiologically relevant model of hypercholesterolemia and endothelial dysfunction, intravenous administration of Chrysalin produced a profound reduction in infarct size. Importantly, the drug was administered after ischemic insult, which reflects the anticipated clinical circumstance of acute myocardial infarction.
