Hepatitis C News: FDA Approves Merit Phase 3 clinical trial protocol to treat primary liver cancer

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FDA Approves Merit Medical's HiQuality Clinical Trial Protocol for the Treatment of Primary Liver Cancer
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SOUTH JORDAN, Utah, Nov. 29, 2010 (GLOBE NEWSWIRE) --
The Food and Drug Administration (FDA) has approved Merit Medical Systems, phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere(TM) 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(TM) 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.
About Liver Cancer
Liver cancer is the third leading cause of cancer deaths worldwide. The sharp rise in hepatitis C infections, alcohol consumption and obesity are reported as key contributing factors to the increase in liver cirrhosis and liver cancer. Liver transplantation or tumor resection is considered potentially a curative treatment; however, only about 25 percent of liver cancers are diagnosed when they can be treated surgically.

Surgical removal is not possible for more than two-thirds of primary liver cancer patients and 90 percent of patients with secondary liver cancer. According to the U.S. National Cancer Institute (NCI), no standard treatment currently exists for liver cancer when tumors cannot be surgically removed and liver transplantation is not a viable option. However, both the NCI and the Society of Interventional Radiologists (SIR) report that transarterial chemoembolization (TACE) has shown promising results.

hqTACE - Merit Advances Chemoembolization
Drug-eluting embolization treats hepatocellular carcinoma through the dual action of delivering chemotherapy into the tumors while also cutting off the blood supply that supports them. QuadraSphere adds two benefits to embolization therapy. First, by ionically binding the doxorubicin throughout the microspheres and eluting it into the cancer in a sustained manner, more drug can be delivered into the tumor, with less escaping into peripheral circulation. Complementary to the targeted delivery, QuadraSphere Microspheres have a unique formulation that makes them highly compressible and conformable, so they mold to the vessel lumen, creating both excellent contact with the vessel walls for delivery of chemotherapy and very efficient occlusion of the vessels feeding the tumor. Initial clinical results have demonstrated improved safety and reduced adverse events compared to treatment by conventional chemoembolization.

About Conventional Transarterial Chemoembolization (cTACE)
Conventional transarterial chemoembolization (cTACE) is a two-stage process involving the injection of chemotherapeutic drugs, typically emulsified with iodized oil, directly into the blood vessels that feed a tumor. The drug is followed by the delivery of an embolic agent used as a plug to block the tumor's blood supply and temporarily retain the cytotoxic drugs in place. However, the occlusion is limited in area and some of the chemotherapy still escapes into circulation, which leads to adverse effects.
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Apricus, FDA agree on liver cancer drug study
Apricus Biosciences Inc. said Monday it reached an agreement with the Food and Drug Administration on the design of a trial for a potential liver cancer drug, making approval more likely if the study is successful.

Apricus is testing a drug candidate called PrevOnco as a treatment for advanced, inoperable liver cancer. PrevOnco has received orphan drug status from the FDA, meaning that if it is approved, the FDA will not approve any competing drugs for seven years.
Orphan drug status is given to treatments for rare diseases. It allows the FDA to promote the development of a drug and optimize its chances for approval. The FDA consults on the design and goals of clinical trials, meaning Apricus can focus trials to provide the specific data the FDA wants to see, making it more likely the agency will approve its application if the trial is successful.

The company said it will conduct a one- to two-year study on around 218 patients with advanced hepatocellular carcinoma, the most common type of liver cancer. Apricus will select patients who have been treated with the drug Nexavar but are no longer responding to it, and for whom surgery is not an option. Patients in the study will receive a combination of PrevOnco, Nexavar, and the chemotherapy drug doxorubicin, or Nexavar, doxorubicin, and a placebo.
If the study is successful, it will be the basis of Apricus' application for marketing approval.
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