Posts tagged Trials

Michael C. Soulen, MD, University of Pennsylvania Medical Center, Professor of Radiology specializes in interventional radiology is the Principal Investigator recently announced a liver cancer chemoembolization international phase III clinical trials with HepaSphere.

South Jordan, Utah (openPR) 7 October 2010

Merit Medical Systems, Inc. (Nasdaq: MMSI), the direction of the phase III clinical trials announced for comparison HepaSphereâ? ¢ microspheres with doxorubicin (known as hqTACE) and conventional trans-arterial chemoembolization (CCAT) for patients loaded with primary liver cancer. HepaSphereâ? ¢ microspheres are now part of the merit of the new range of embolic treatment product.

The study, interventional radiologists worldwide to treat patients with inoperable locally hepatocellular carcinoma (HCC), the most common form of liver cancer. Michael Soulen, MD, University of Pennsylvania Medical Center, Professor of Radiology specializes in interventional radiology, will be the principal investigator of the multicenter phase III clinical trial for liver cancer clinics. Riccardo Lencioni, will monitor MD imaging examination and evaluation of tumor response, and Josep M. Llovet, MD, will chair an independent Data Safety Monitoring Board. Lencioni is an associate professor of radiology and director of diagnostic imaging and intervention in the Department of Liver Transplantation, Hepatology and Infectious Diseases, University of Pisa in Italy. Dr. Llovet is Professor of Research, BCLC Group, Liver Unit, Barcelona, Spain.

Although different markets HepaSphereâ? ¢ QuadraSphereâ? ¢ are identical microspheres for targeted embolization controlled. HepaSphere is CE marked in the European Union since 2005 for the treatment of liver cancer, and in 2007 received the additional indication of the delivery of doxorubicin for the treatment of hepatocellular carcinoma and metastatic liver tumors. United States are currently no approved embolic microspheres for the treatment of liver cancer. QuadraSphere approved by the FDA in the United States for embolization of tumors and arteriovenous malformations devices.

The primary endpoint of the study is overall survival. Other parameters include the assessment of objective response to tumor necrosis base total adverse events and side effects, which refers to doxorubicin, length of hospital stay and time to progression of the incurable cancer.

cardiology and interventional radiology symposium Europe (CIRSE) conference in Valencia, Spain this week, four internationally renowned researchers in the field of treatment for liver cancer Maurizio Grosso, MD, Cuneo, Italy, Geert Maleux, MD, Leuven, Belgium, Cristina Sottani, MD, Pavia, Italy, and Peter Huppert, MD, Darmstadt, Germany presents new results on the symposium entitled HepaSphere microspheres: development of treatment options. The meeting, chaired by Thomas J. Kröncke, MD, focused on whether it is the survival data are currently very few studies of drug delivery embolization for HCC published, most data currently available survival of clinical studies by Drs . Maleux Grosso, who studied over 140 patients between them, and their encouraging results demonstrate the necessity and the value of a large study of patients enough to survive between CCAT compare the standards of health care and Drug Administration (hqTACE).

Maleux commented on the use of HepaSphere in the next clinical study, “HepaSphere is safer compared to patients with fewer side effects with conventional TACE. It is an important basis for this multi-center trial. We are for the survival data may look better wider base group, and where there is no difference in survival rate Hepasphere has much fewer side effects and patients left the hospital earlier, but of course we would rather not only security but also a better survival. “

Dr. Grosso, which published the original study hqTACE on 50 subjects, presented new data developed comparing the results of the first 100 patients, shows the value of a larger study. Mr. Grosso compared survival of patients with liver cancer treated with doxorubicin HepaSphereâ loaded? ¢ microspheres (hqTACE), conventional TACE with doxorubicin and Embosphere ® microspheres, another product of embolic merit and conventional TACE with gelfoam, embolism absorbable. The cohort was treated with HepaSphere the best chance of survival.

Maleux presented data from a prospective, randomized study comparing hqTACE and CCAT. The results showed a statistically significant reduction of serious side effects hqTACE in the arm. HqTACE group had a low circulation of doxorubicin, which greatly reduces serious side effects of drug toxicity and resulted in better-preserved liver function.

Sottani presented data comparing the first side-to-head results between pharmacokinetic HepaSphere microspheres and DC Beadsâ? ¢. The amount of the drug was responsible identical between the two but HepaSphere microspheres embolization showed a news weakness, with a much lower peaks in traffic doxorubicin and drug release.

Dr. Peter Huppert, Darmstadt, Germany presents new data on the possibility of using other HepaSphere deliver chemotherapy drugs, particularly for irinotecan in patients with liver metastases from colon cancer. No major complication was observed in a Phase II study of 15 patients with inoperable liver metastases. Three months follow-up showed the fight against the disease in 87% of patients based on criteria mRECIST. After six months of follow-up, 46% of patients experienced disease control. The median time to progression was 6.3 months (range 2-14 months). Dr. Huppert full report on the RI Convention News online, 5 October. 2010th

clear = “all”
ut City Park