FDA approves Merit's phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere Microspheres

First large-scale multi-site U.S. study comparing doxorubicin-eluting QuadraSphere™ Microspheres to conventional chemoembolization

Interventional radiologists from U.S., Europe, South America participating in liver cancer study

The Food and Drug Administration (FDA) has approved Merit Medical Systems, Inc.'s (Nasdaq:MMSI) phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere^™ Microspheres (hqTACE) for delivery of doxorubicin. The clinical trial will involve U.S. and international interventional radiologists who treat patients with localized, unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.  The FDA action will result in the first phase 3 study in the U.S. comparing drug-eluting microspheres to conventional chemoembolization (cTACE) in the treatment of hepatocellular carcinoma. Currently in the U.S. there is no FDA-approved embolic for the treatment of liver cancer.

QuadraSphere is indicated for embolization of hypervascular tumors and peripheral arteriovenous malformations.  The identical product marketed in Europe as HepaSphere Microspheres^™ has been CE-marked in the European Union since 2007 for embolization of HCC and hepatic metastases, with or without delivery of doxorubicin.  

"I am extremely pleased with the efforts of our BioSphere Regulatory and Medical Affairs Department headed by Dr. Melodie R. Domurad, PhD," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. "We are very excited about the initiation of this important study."

Merit Medical is a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy.  It has recently added the BioSphere microsphere products to its line of tumor treatment options.

The phase 3 study is a prospective, randomized, blinded and controlled investigation of HepaSphere/QuadraSphere Microspheres for delivery of doxorubicin for the treatment of hepatocellular cancer. Known as the HiQuality Study (HepaSphere/QuadraSphere in Liver Cancer Treatment), the primary endpoint of the clinical trial is survival.  Secondary endpoints include tumor response by mRECIST criteria, safety, resource utilization such as length of hospitalization, and adverse events.  The study will enroll 500 patients and be conducted in approximately 20 clinical sites in the U.S., Europe, and South America. 

Dr. Riccardo Lencioni, who developed the guidelines for image acquisition and interpretation for the trial stated, "This study meets the highest standards for clinical research in hepatocellular carcinoma, as recommended in Design and Endpoints of Clinical Trials in Hepatocellular Carcinoma, guidelines for clinical research in HCC by an expert panel convened by the American Association for the Study of Liver Disease, and published in the Journal of the National Cancer Institute. The design of the investigation is rigorous, and has been extensively reviewed by the FDA."

Dr. Lencioni, M.D., Associate Professor of Radiology at the University of Pisa in Italy and Director of the Division of Diagnostic Imaging and Intervention at the Department of Hepatology and Liver Transplantation at the Pisa University Hospital, will be overseeing the central imaging review and evaluation of tumor response.  Professor Lencioni is Chairman of the Membership Committee and a member of the Executive Committee of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) and Chairman of the Programme Committee of the European Conference on Interventional Oncology (ECIO).  He is also a member of the Steering Committee of the World Conference on Interventional Oncology (WCIO).  Professor Lencioni has been one of the founders of the International Liver Cancer Association (ILCA), and is a member of the Governing Board.  Professor Lencioni has received more than 40 international awards; authored 134 articles or editorials; and is the editor of seven books.  Professor Lencioni has served on the editorial board of Cardiovascular and Interventional Radiology, Investigative Radiology, European Radiology, Journal of Hepatology, Journal of Interventional Oncology, and La Radiologia Medica.

Michael Soulen, M.D. from the University of Pennsylvania Medical Center and Professor of Radiology specializing in Interventional Radiology, will direct the study as principal investigator. Active in the Society of Interventional Radiology (SIR), Dr. Soulen has served on the Executive Council, chaired the 1999 Annual Scientific Meeting, and acted as Director of Research Education for the SIR Foundation.  He also serves on committees of the Radiological Society of North America (RSNA) and the American College of Radiology (ACR).  Dr. Soulen chairs the steering committee of the World Conference of Interventional Oncology (WCIO).  He is also an editorial board member and/or reviewer for numerous publications, including the Journal of Vascular and Interventional Radiology.  He has published nearly100 peer-reviewed articles and more than 50 editorials, chapters and invited manuscripts.