ZUG and ROTKREUZ, Switzerland -- Cardiorentis AG, a privately held biopharmaceutical company, today announced a collaboration with Roche to establish the therapeutic efficacy and safety of Ularitide, the Company's investigational drug for acute heart failure (AHF). Under the terms of the collaboration, Cardiorentis will incorporate Roche's advanced in vitro diagnostic tests into its TRUE-AHF Phase III Study to characterize the pharmacological properties of Ularitide, evaluate its benefit-risk profile and the appropriate clinical application in patients.
"Roche is the world leader in in vitro diagnostics and has been consistently recognized for its breakthrough medical innovations for the treatment of cardiovascular diseases. This collaboration allows us to incorporate the most advanced biomarkers into our TRUE-AHF trial and we are hopeful it will result in proven outcome benefits for patients with acute heart failure," stated Johannes Holzmeister, M.D. Chief Executive Officer and Chief Medical Officer, Cardiorentis.
"Our in vitro diagnostic tests provide critical clinical information addressing doctor's needs to guide the patient's treatment regime. Incorporating these tests into the TRUE-AHF trial will enable us to further validate their clinical value in a large patient population but more importantly advance the development of new treatment options for acute heart failure," added Prof. Christian Zaugg, Head of Disease Area Strategy at Roche Professional Diagnostics.
The TRUE-AHF Phase III trial was initiated in August 2012. It is led by the international principal investigator Milton Packer, M.D., University Texas, Southwestern Medical Center in Dallas, Texas and includes over 200 centers across the U.S., Europe, Canada andLatin America. TRUE-AHF is an event driven trial, which may enroll up to 4,000 patients with acute heart failure. There are two co-primary endpoints. The first is a composite endpoint for acute heart failure which assesses a patient's symptoms and persistence or worsening of heart failure within the first 48 hours after treatment initiation. The second co-primary endpoint is cardiovascular mortality.
Ularitide is a natriuretic peptide in Phase III development as an intravenous infusion treatment for acute heart failure (AHF), limited byUnited States law to investigational use only. Ularitide is the chemically synthesized form of urodilatin - a human, natriuretic peptide that is produced in the kidneys and induces excretion of sodium into the urine (natriuresis) and increased urine production (diuresis) to regulate fluid balance and sodium homeostasis. Ularitide induces natriuresis and diuresis by binding to specific natriuretic peptide receptors (NPR-A, NPR-B and other natriuretic peptide receptors), thereby increasing intracellular cyclic guanosine monophosphate (cGMP) helping to relax smooth muscle tissues, leading to vasodilation and increased blood flow.
Heart failure is a growing problem worldwide. More than 26 million people around the world are affected., AHF can be defined as the sudden or gradual onset of the signs or symptoms of heart failure resulting in a need for urgent therapy or hospitalisation. In 2011, there were nearly 3 million hospital admissions with heart failure as the primary diagnosis in countries across the globe. It is a life-threatening condition which requires immediate medical attention. Signs and symptoms of AHF include extreme fatigue and shortness of breath, worsening kidney function, severe swelling, sudden weight gain and a distended jugular vein along the side of the neck.
About Cardiorentis Ltd.
Cardiorentis is a private biopharmaceutical company headquartered in Zug, Switzerland. Cardiorentis is committed to bringing novel therapies to the treatment of heart failure and related cardiovascular diseases. The company's disease-based technology platform integrates expertise in protein biology to identify novel targets and rationally design small molecule compounds and peptides for markets with unmet medical needs. For more information, visit http://www.cardiorentis.com.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, anti-malarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss Francs in R&D and posted sales of 46.8 billion Swiss Francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
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