20 November 2013

Results of Multicenter, Randomized Study Show Left Ventricle Augmentation with Hydrogel Implant Provides Functional Improvement in Health Status

DALLAS, November 20, 2013 — LoneStar Heart, Inc. today presented the interim results of its multicenter, randomized AUGMENT-HF clinical trial showing left ventricle augmentation of the failing heart with the company’s lead product, Algisyl-LVR hydrogel implant, can be performed safely in patients with advanced heart failure (HF) and provides functional improvement in their health status. The study is being conducted at 15 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.

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 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 late-breaking clinical trials session of the American Heart Association annual meeting held at the Dallas Convention Center. Dr. Mann is a member of LoneStar Heart’s scientific advisory board.

“We are highly encouraged by what we have seen thus far in the Algisyl-LVR treatment group,” said Dr. Mann. “We look forward to the conclusion of the AUGMENT-HF study in a few more months.”

Based on the interim results, Dr. Mann concluded that Algisyl-LVR use in patients with advanced HF is both feasible and safe, while the efficacy analysis suggests that Algisyl-LVR leads to an improvement in quality of life and functional capacity in comparison to patients who are treated with optimized medical therapy. However, he emphasized that the conclusions are provisional based on the limited patient numbers and the brief follow-up time.

In the pre-specified interim analysis, 14 Algisyl-LVR recipients were compared to 15 control patients who continued to be managed with standard heart failure medications. The Algisyl-LVR implants were successfully performed with no device-related complications. There was no 30-day mortality or significant arrhythmia observed in the Algisyl-LVR group. In one outcome measured, the Algisyl-LVR group had a significant improvement in the 6-Minute Walk Test (6-MWT) at 3 months, as evidenced by a distance from 234.4±66.8m at baseline to 327.6±96.6m (p=0.01). Whereas patients in the control group had a decline in the 6-MWT at 3 months (304.5±76.4m at baseline; 294.6±96.2m at 3 months; p = 0.773).

Using the New York Heart Association functional classification, a measure of the degree of heart failure used widely by cardiologists, there was a highly significant improvement of NYHA class with Algisyl-LVR (3.13±0.35 at baseline to 2.27±0.47 after 3 months; p<.0001); while the control group had a non significant decrease in NYHA class (2.93±0.59 at baseline to 2.75±0.62 at 3 months; p=0.446). Moreover, the comprehensive Kansas City Cardiomyopathy Question­naire used to assess patients quality of life also yielded statistically significant results, showing the Algisyl-LVR patients improved their index from 39.2 at baseline to 58.6 after 3 months (p=0.017), compared to 56.5 to 65.2 respectively for the control group.

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.

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. Algisyl-LVR was initially tested in a safety study in patients with an enlarged left ventricle who also needed a bypass or a valve repair procedure, with long-term follow-up of these patients, and successful outcomes reported elsewhere.

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.

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