Patients treated with HepaSphere™, compared to patients who received conventional transarterial chemoembolization (cTACE), had lower circulating levels of doxorubicin, which significantly reduced drug toxicity and serious side effects.
Rockland, MA (PRWEB) March 16, 2010
BioSphere Medical, Inc. (NASDAQ: BSMD), announced that its doxorubicin delivery embolotherapy microspheres HepaSphere™ were featured in a scientific session on the advances in minimally invasive treatments for liver cancer, at the Society of Interventional Radiology (SIR) 35th Annual Meeting, in Tampa, FL. Opening the session on transarterial chemoembolization (TACE) for liver cancer, Geert Maleux, M.D., Ph.D., an interventional radiologist at the University Hospitals Leuven, Belgium, presented the results of the first prospective, randomized clinical study demonstrating the effectiveness of HepaSphere™ to treat patients with hepatocellular cancer (HCC), the most common form of liver cancer.
Dr. Maleux’s study, conducted in Belgium, demonstrated the safety of HepaSphere™ drug delivery chemoembolization (hqTACE). Patients treated with HepaSphere™, compared to patients who received conventional transarterial chemoembolization (cTACE), had lower circulating levels of doxorubicin, which significantly reduced drug toxicity and serious side effects. The hqTACE patients also had better preserved liver function.
Today’s presentation spotlights the significant advances achieved by the company in liver cancer treatment. BioSphere has submitted an Investigational Device Exemption (IDE) application to the U.S. FDA for QuadraSphere® Microspheres for a phase III clinical trial. If approved, it will be the first phase III clinical trial for chemoembolization of primary liver cancer in the United States.
HepaSphere™ Microspheres, however, have been CE marked in the European Union since 2007 for embolization of liver cancer and hepatic metastases, with or without delivery of doxorubicin. In the United States, QuadraSphere® is cleared by the FDA for embolization of hypervascularized tumors and peripheral arteriovenous malformations.
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.
In a related presentation, Diane K. Reyes, Department of Radiology and Radiological Sciences, Johns Hopkins University School of Medicine, Baltimore, presented results of a Phase II two-year, single-arm clinical study that treated patients with unresectable liver cancer with bevacizumab (Avastin®) and conventional TACE (cTACE) using Embosphere® Microspheres. This pilot study evaluated tumor response and safety of liver chemoembolization combined with an antiangiogenic drug that works by preventing new blood vessel growth. The data showed treatment was well tolerated, with progression-free survival of 16 months.
BioSphere Medical, Inc. (NASDAQ:BSMD) is a medical device company that develops and manufactures bioengineered microspheres for use in embolotherapy, which is the minimally invasive treatment of tumors and vascular malformations by inhibiting blood flow. The Company's core technologies, patented bioengineered polymers and manufacturing methods, are used to produce microscopic spherical materials with properties that may be beneficial in a variety of medical applications. Most notably, the company was a pioneer in uterine fibroid embolization (UFE) when it launched the first approved embolic microsphere for UFE. The Company has a dominant worldwide position in UFE embolics and has developed microspheres for use in interventional oncology. BioSphere is expanding its clinical research on the use of its microspheres in liver cancer chemoembolization and other disease states. For more information, consult the company’s website at http://www.biospheremed.com/index.cfm
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the Company’s planned HepaSphere™/QuadraSphere® in Liver Cancer Treatment clinical trial, the expected benefits of HepaSphere and QuadraSphere for the treatment of liver cancer, and the effectiveness of HepaSphere™/QuadraSphere® to deliver the chemotherapeutic drug doxorubicin in patients with hepatocellular cancer; and treatment benefits of Embosphere® and bevacizumab in liver cancer. The Company may use words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should," "intends," "looking forward," and similar expressions to identify these forward-looking statements. These statements are subject to risks and uncertainties and are based upon the Company's beliefs and assumptions. There are a number of important factors that may affect the Company's actual performance and results and the accuracy of its forward-looking statements, many of which are beyond the Company's control and are difficult to predict. These and other risk factors are discussed under “Risk Factors” and elsewhere in BioSphere Medical, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2008, in its Quarterly Report on Form 10-Q for the quarter ended December 31, 2009 and other filings that the Company makes from time to time with the U.S. Securities and Exchange Commission (SEC). BioSphere Medical, Inc. expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.