LoneStar Heart Announces First Patient in AUGMENT-HF Clinical Trial of Algisyl-LVR™ for the Treatment of Heart Failure IRCCS San Raffaele Pisana/Umberto I Policlinico First in Multicenter Randomized Trial to Evaluate Implantable Biopolymer's Safety and Efficacy

LAGUNA HILLS, Calif., Oct. 1, 2012 /PRNewswire/ -- LoneStar Heart Inc., based here, today announced the first patient was treated in the company's international multi-center AUGMENT-HF clinical trial of Algisyl-LVR at IRCCS San Raffaele Pisana and at Umberto I Policlinico, both located in Rome, Italy. The AUGMENT-HF clinical study follows on the success of a pilot study at the German Heart Center in Munich and Heart Center Dresden that established the safety and feasibility of Algisyl-LVR in severe heart failure patients.

AUGMENT-HF is a randomized, controlled 76-patient clinical study designed to validate the clinical benefits of Algisyl-LVR™ for patients with severe heart failure. The study is taking place in major hospitals in Italy, Australia, New Zealand, and The Netherlands.

Classified as a medical device by the U.S. Food and Drug Administration (FDA) and the European Union (EU), Algisyl-LVR is injected directly into strategic areas of the left ventricle muscle during surgery. As it is injected, the biopolymer thickens and forms gel-like bodies that remain in the heart muscle as permanent implants providing internal support to the injured heart, reducing the ventricle's tension and stress, and preventing the progression of HF. Early results of human testing indicate the biopolymer can help restore the heart's normal structure and function with a significant improvement in the patient's quality of life.

According to Maurizio Volterrani, M.D., a leading Italian cardiologist and the principal investigator of the clinical trial at IRCCS San Raffaele Pisana, Algisyl-LVR represents a new treatment strategy based on a medically accepted principle that a reduction in muscle tension and wall stress of the dilated heart will improve its function. "We are encouraged by the results of previous studies of the biopolymer indicating it not only improves the hearts pumping efficiency, but also demonstrates positive biological effects and reversal of the pathological remodeling of the heart's shape that's characteristic of the condition." The patient's surgery was conducted by cardiac surgeon Fabio Miraldi, M.D., at Umberto I Policlinico.

Algisyl-LVR

Algisyl-LVR is not biologically active and it does not cause the body's immune system to reject it. It's ability to reduce heart muscle tension and cell stress appears to allow the heart's natural healing to not only stop the disease process, but actually shows signs of reversing it. LoneStar Heart is testing the biopolymer to prevent or reverse the progression of HF in patients who have an enlarged left ventricle as a result of a heart attack, a valve malfunction, inadequate blood supply to the heart muscle, or other heart disorders.

In its current product version, the biopolymer is delivered through a small surgical incision in the chest (minimal thoracotomy) in a beating heart procedure with a typical duration of less than 60 minutes. A second product version in development is expected to offer patients a procedure that can be performed by interventional cardiologists and other specialists in a noninvasive or hybrid cardiology laboratory.

AUGMENT-HF patients will be followed over a two-year period. The primary endpoint to be measured at six months post-treatment is so-called "peak VO2" — the maximum amount of blood oxygen the heart can provide to muscles during sustained physical activity. Although patient follow-up will continue for two years, LoneStar Heart anticipates a CE clearance to market Algisyl-LVR in Europe in 2013. The company is also working with the FDA to allow for clinical evaluation and eventual marketing clearance in the United States.

Heart Failure

Caused by acute heart attack to valve disease and chronic atrial fibrillation, HF is a disease syndrome that leads to pathologic remodeling of the left ventricle — the main pumping chamber of the heart that's responsible for moving 2,500 gallons of blood a day. Over time the ventricle begins to stretch and enlarge, the muscle wall becomes thin, and the chamber loses its elongated shape to become more spherical, resulting in inadequate pumping of blood to meet the body's needs. As the disease mechanisms are set in motion, this negative chain of events cannot be reversed with conventional treatments such as diuretics, vasodilators, and drugs aimed at strengthening the heart's contraction. Cardiac resynchronization therapy and ventri­cular assist devices may be used in later disease stages. But these implantable devices have severe cost and lifestyle limitations, and are applicable to a relatively small patient segment.

HF represents a growing health and economic burden in all developed countries with a total cost of $39.2 billion in the U.S. alone. About 12.7 million patients are affected in the U.S. and in Western Europe. In the U.S. each year 550,000 new cases of HF are diagnosed and 300,000 deaths are caused by the condition. The National Institutes of Health estimates there will be 10 million HF patients by 2020.

IRCCS San Raffaele Pisana and Policlinico Umberto I di Roma

The IRCCS San Raffaele Pisana, a subsidiary of San Raffaele, SpA, is a leading Italian research and teaching hospital. The hospital's Cardiac Rehabilitation Unit specializes in the rehabilitation of patients recovering from heart surgery or an acute cardiac episode such as a heart attack. Policlinico Umberto di Roma, is one of Italy's leading cardiac surgery centers.

LoneStar Heart Inc.

LoneStar Heart Inc. is developing cardiac restorative therapies for patients with HF 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.



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