LoneStar Heart, Inc., a biomedical company, develops cardiac restorative therapies for patients with heart failure. It develops a portfolio of device and drug based programs for congestive heart failure. The company develops Algisyl LVR, a self-gelling implantable biopolymer that is implanted in the heart for preventing or reversing the progression of advanced heart failure in patients who have an enlarged left ventricle as a result of a myocardial infarct, mitral valve regurgitation, ischemia, arrhythmias, and other disorders; and Isoxazoles, small molecule drugs for the treatment of heart failure. The company also develops cell reprogramming cardiac fibroblasts for the regeneration of card...
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LoneStar Heart, Inc. Reports Successful One-Year Results of Randomized Clinical Trial on Efficacy of Algisyl® in the Treatment of Heart Failure
Nov 11 15
LoneStar Heart, Inc. presented and published the one-year extended follow-up results of AUGMENT-HF, an international randomized, multi-center clinical trial to evaluate the safety and efficacy of Algisyl. Classified as a medical device, Algisyl is a novel hydrogel that is implanted into specific areas of the failing heart muscle to improve cardiac function and clinical symptoms in advanced heart failure patients. Algisyl is approved for use in the European Union. The U.S. Food and Drug Administration recently approved an Investigational Device Exemption that allows the company to initiate a pivotal clinical study of Algisyl in the United States subject to certain conditions. The presentation was given by Douglas L. Mann, M.D., Professor and Chief, Cardiovascular Division of Washington University School of Medicine and Cardiologist-in-Chief, Barnes Jewish Hospital, St. Louis, Mo., at the late-breaking trials session of the annual meeting of the American Heart Association held in Orlando. The study compared the safety and efficacy of Algisyl combined with standard medical therapy to standard medical therapy alone. The primary endpoint of efficacy is peak VO2, a measure of maximal aerobic capacity that is considered the best indicator of cardiovascular health because it correlates strongly with clinical symptoms, morbidity and mortality. Patients treated with Algisyl had a significant improvement at 12 months where the mean treatment effect was an increase of 2.10 mL/kg/min (95% confidence interval, CI 0.96–3.24, P < 0.001) vs controls. This result represents a sizeable continued improvement over the 6-month data published recently where the treatment effect was 1.24 mL/kg/min. Similarly, the 6-minute walk test, another efficacy measure, showed a significant difference of 101 meters in favor of the Algisyl group. Lastly, New York Heart Association (NYHA) functional class at 12 months was significantly improved in the Algisyl group with 85% of patients observed to be in NYHA Class I or II. Among the controls, only 25% of patients were observed to be in NYHA Class II and none in Class I. The clinical trial analysis was not statistically powered to assess mortality or morbidity. At the 12-month follow-up, there were 13 deaths including 4 in the control group and 9 in the treatment group. The overall incidence of serious adverse events was not significantly different between the Algisyl and the control group. However, Algisyl patients experienced substantially lower rates of worsening heart failure (34.2% of control patients vs. 15.0% of Algisyl patients) and sustained ventricular arrhythmias (13.2% of control patients vs. 2.5% of Algisyl patients).