ORLANDO, Fla., Nov. 11, 2015 /PRNewswire/ -- LoneStar Heart, Inc. today 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 was also published online today in European Journal of Heart Failure. The article, "One Year Follow-Up Results from AUGMENT-HF: A Multicenter Randomized Controlled Clinical Trial of the Efficacy of Left Ventricular Augmentation with Algisyl in the Treatment of Heart Failure," was authored on behalf of the AUGMENT-HF study group by Dr. Mann and Stefan D. Anker, M.D., Ph.D., Professor of Innovative Clinical trials at the University of Gottingen.
"The outcomes from the AUGMENT-HF study reported today confirm that Algisyl patients experienced significant improvements over the controls. These improvements were larger and more significant than the previously reported 6-month follow-up showing continued benefit. These results support further evaluation of this novel therapeutic approach," said Dr. Mann.
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).
Algisyl and Advanced Heart Failure
Algisyl is a novel tissue-engineered product developed to stop and reverse the damaging effects of ventricle enlargement providing an alternative to current treatments. Algisyl is a highly biocompatible, inert hydrogel sourced from brown marine algae that is injected into the enlarged left ventricle muscle where it remains as a permanent scaffold. Algisyl thickens the wall and reshapes the heart to reduce muscle tension and improve pumping efficiency. Clinical outcomes indicate this mechanism leads to an improvement in exercise capacity and clinical symptoms.
Advanced heart failure represents a growing epidemic healthcare burden in all developed countries. Of the more than 12 million patients affected in North America and Western Europe, about a third have significant limitations of physical activity and half die within five years of diagnosis.
Heart failure is triggered by damage to the cardiac muscle that leads to a decrease in blood pumping capacity, an increase in exercise intolerance, and a gradual deterioration in quality of life. In at least half of all patients, the left ventricle of the heart steadily enlarges and stretches resulting in a thinner muscle that is unable to work efficiently. Drugs can be effective in controlling the clinical symptoms particularly in the early disease stage. However, a significant number of patients do not respond or cease to respond to drugs eventually requiring a heart transplant or mechanical circulatory support.
LoneStar Heart, Inc., based in Laguna Hills, Calif., is a privately held biomedical company developing breakthrough therapies for the treatment of heart failure. Its lead product, Algisyl, is classified as a medical device that improves the clinical symptoms and reverses the progression of advanced heart failure. The company also holds a broad portfolio of biologic and pharmaceutical products to restore the failing heart's structure and function. LoneStar Heart operates in the U.S., Europe, and China, and collaborates with a global network of leading scientists and clinicians. For more information, visit http://www.lonestarheartinc.com
SOURCE LoneStar Heart, Inc.