LoneStar Heart Completes Recruitment for Randomized Clinical Trial of Algisyl-LVR® Hydrogel Implant for Advanced Heart Failure
Six-month Outcomes of AUGMENT-HF Multicenter Study to Be Presented by Yearend
LAGUNA HILLS, Calif., May 5, 2014 — LoneStar Heart, Inc. today announced that it completed the patient recruitment phase of the company’s AUGMENT-HF controlled randomized trial of Algisyl-LVR hydrogel implant, its lead product for the treatment of advanced heart failure (HF). LoneStar Heart expects to present six-month outcomes by yearend.
The AUGMENT-HF clinical trial is being conducted at 14 centers in Italy, Germany, Romania, Australia, and The Netherlands to determine if the product is superior to standard medical therapy in the management of patients with a dilated and weakened left ventricle and significantly deteriorated cardiac function.
“We are grateful to all of our clinicians for their hard work and contributions for helping us reach this critical milestone,” said Frank Ahmann, LoneStar Heart’s president and chief operating officer. “While patient follow-up will continue for two years, we look forward to presenting the primary endpoints in a few more months considering the potential for Algisyl-LVR to revolutionize the treatment of patients with advanced heart failure.”
As reported last November 2013 at the American Heart Association annual meeting in Dallas, interim results of the study showed left ventricle augmentation of the failing heart after implantation with Algisyl-LVR can be performed safely in patients with advanced heart failure and provides functional improvement in their health status. Extensive preclinical studies have shown Algisyl-LVR decreases cardiac wall tension, while it improves heart muscle contractility and oxygen uptake, leading to a decrease in ventricle stress and to a marked cardiomechanic improvement.
Classified by the U.S. Food and Drug Administration as a medical device, Algisyl-LVR is intended to reverse HF progression in patients who have an enlarged left ventricle. The product consists of a proprietary hydrogel that is injected directly into strategic areas of the dilated left ventricle muscle in a surgical procedure lasting approximately 75 minutes. Performing the function of a prosthetic scaffold, the hydrogel acts immediately and does not undergo long-term degradation.
Advanced Heart Failure
Advanced HF represents a significant and growing epidemic healthcare burden in all developed countries. Of the more than 12 million patients affected in the North America and in Western Europe, about a third have significant limitations of physical activity while half die of heart failure within five years of diagnosis. A wide number of patients whose heart muscle is initially damaged by infarcts, hypertension, valve disease, or other processes lose the ability to pump blood efficiently to the body. To overcome the initial damage, the heart muscle works under increased stress without an opportunity to recover. Eventually, the muscle of the left ventricle begins to stretch out and the muscle cells lose the ability to contract normally. The therapeutic options for many of these patients who do not respond to drug and device therapies are limited and can be extremely complex and costly.
LoneStar Heart Inc.
LoneStar Heart, Inc., based in Laguna Hills, Calif., is developing cardiac restorative therapies for patients with heart failure that harness the heart’s ability to repair itself. Based on its integrated cardiomechanical and biomolecular technologies, the privately held company is advancing a broad portfolio of products to restore the failing heart’s structure and function in collaboration with the Texas Heart Institute, the University of Texas Southwestern Medical Center, and a global network of leading clinicians. These products include Algisyl-LVR, cardiac stem-cell modulators, and cellular and genetic therapies delivered as stand-alone treatments, or in combination with the company’s proprietary biopolymer matrix system.