The German Federal Institute for Drugs and Medical devices (BfArM) authorized the start of two clinical trials for a liver support therapy developed by the Munich-based medical device company Hepa Wash GmbH. The approval process examined the technical requirements as well as the plausibility of the study design. In March, Hepa Wash already received the required favorable opinion of the Ethics Committee of the hospital rechts der Isar of the Munich Technical University.
"We got the approvals within only six weeks. We owe this to the huge efforts of the Hepa Wash team who properly prepared all necessary technical documents and study protocols. Now we can proceed with the clinical evaluation in the third quarter of the year,” says Dr. Bernhard Kreymann, CEO of Hepa Wash. The treatment aims to reduce the very high mortality rate of patients with liver failure. Recent studies revealed that existing therapies can hardly achieve any positive effects on survival. However, the Hepa Wash procedure has a significantly increased detoxication capacity and is therefore expected to improve the survival rate of affected patients for at least 30 percent. Two preclinical studies already showed the beneficial effects of the procedure. The studies were supported by the Bavarian Research Foundation (Bayerische Forschungsstiftung).
"Each of the two studies approved by the BfArM shall include over 150 participants, whose liver failed for different reasons," explains Dr. Ahmed Al-Chalabi, Chief Clinical & Regulatory Officer. "Only patients who are in the intensive care unit can be enrolled," adds Al-Chalabi. The studies shall be initiated at II. Medical Clinic in the hospital rechts der Isar and extended in early 2011 to involve more clinical centers. The completion of the studies is planned for end of 2012.
Hepa Wash GmbH, which is located in the "Munich Technology Center" (MTZ), works since its foundation in 2005 on a new liver support therapy, to reduce the high mortality of critically ill patients with liver failure. The data of the in-vitro- and preclinical studies confirm the effects of the patented procedure. In November 2009 another financing round was successfully completed. With those means, the construction of a human prototype was financed. The prototype’s technical safety was certified by TÜV Süd in March 2010. Parallel to the TÜV certification, preparations for the clinical studies were made.
Design of the clinically studies.
Description of Hepa Wash-technology.