CHICAGO, Nov. 18, 2014 /PRNewswire/ -- LoneStar Heart, Inc. today presented the primary six month results of its multicenter, randomized clinical trial of Algisyl-LVR® providing evidence that the cardiac hydrogel implant can prevent or reverse the symptoms of moderate to severe heart failure in patients with a dilated and weakened left ventricle. The improvement in clinical status and quality of life of the patients was consistent with reported data that demonstrates the cardiac hydrogel works by improving the failing heart's structure and function.
CE Marked and approved for marketing in Europe, Algisyl-LVR is LoneStar Heart's lead product for the treatment of advanced heart failure (HF). Classified in Europe and in the U.S. as a medical device, it is intended to reverse HF progression in people who have an enlarged left ventricle. Surgically injected directly into the heart muscle, the hydrogel acts immediately as an internal scaffold to increase cardiac output, without undergoing long-term degradation.
Following extensive preclinical research and a prior clinical study carried out in Germany, the AUGMENT-HF trial was conducted at 15 centers in Italy, Germany, Romania, Australia, and The Netherlands. The study was specifically designed to determine whether treatment with Algisyl-LVR offers benefits to patients with decreasing cardiac function who are not responding to optimal drug therapy in a heart failure condition known as dilated cardiomyopathy of either ischemic or non-ischemic origin.
Entitled, "A Multicenter, Randomized Study Assessing the Efficacy of Left Ventricular Augmentation with Algisyl-LVR in the Treatment of Advanced Heart Failure Patients with Ischemic and Non-ischemic Cardiomyopathy: The AUGMENT-HF Study," the presentation was made 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 annual meeting of the American Heart Association's Clinical Trial Sessions held this week in Chicago.
Dr. Mann, who is also a member of LoneStar Heart's scientific advisory board, said, "The AUGMENT-HF study supports the concept that reducing ventricular wall stress in heart failure patients through the implant of Algisyl leads to improved functional capacity of the heart and corresponding clinical symptoms. We look forward to continue monitoring the safety and the durability of this novel therapy because it represents a potential alternative that is badly needed in the treatment of Advanced Heart Failure patients."
The clinical trial measured various safety and efficacy endpoints to build upon the evidence of the risks and benefits of Algisyl-LVR. Of all of these parameters, peak VO2, a measure of maximal aerobic capacity, is considered the best indicator of cardiovascular health because it correlates strongly with clinical symptoms, as well as morbidity and mortality in heart failure patients. In AUGMENT-HF, the change in peak VO2 was assessed by blinded core lab. Patients treated with Algisyl-LVR had an average improvement from 12.1 to 13.2 ml/min/kg after only six months whereas patients treated with optimal drug therapy remained essentially unchanged.
Similarly, a 6-minute walk test showed that Algisyl-LVR patients had an improved walking distance of 85 meters as opposed to a decrease of 15 meters in the control group. Both peak VO2 and 6-minute walk test outcomes show strong statistical significance. Patient follow-up will continue for two years and additional data will be reported.
"Following the completion of the study's patient recruitment in April and the European approval to market in October, Algisyl is entering an exciting stage of development," said Frank Ahmann, LoneStar Heart's president and COO. "Today we are presenting solid initial evidence that Algisyl-LVR can stop and reverse the deterioration of cardiac function in patients whose treatment options are very limited. In the coming months, we believe this evidence will continue to grow and gain strength as we follow up with enrolled patients and add new ones to our future studies and registry."
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.
For more information on Algisyl-LVR and LoneStar Heart Inc. see http://www.lonestarheartinc.com
SOURCE LoneStar Heart, Inc.