BioSphere Medical to Participate in Phase II Liver Cancer Study at The Johns Hopkins University School of Medicine.ROCKLAND, Mass. -- BioSphere's Embolization embolization /em·bo·li·za·tion/ (em?bo-li-za´shun) 1. the process or condition of becoming an embolus. 2. therapeutic introduction of a substance into a vessel in order to occlude it. Products to be Investigated in Combination with Avastin(R) (bevacizumab) at World Renowned Health Care and Academic Research Institution BioSphere Medical, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BSMD), a medical device company that pioneered the use of bioengineered microspheres to treat uterine fibroids Uterine Fibroids Definition Uterine fibroids (also called leiomyomas or myomas) are benign growths of the muscle inside the uterus. They are not cancerous, nor are they related to cancer. , hypervascularized tumors and vascular malformations by a procedure called embolization, today announced its participation in a Phase II, single-arm clinical study to treat patients with primary liver cancer. The 30-patient, two-year study combines, for the first time, Avastin(R) (bevacizumab) with chemoembolization therapy utilizing BioSphere's patented Embosphere(R) Microspheres. The study is expected to commence in June 2006, and will be conducted under the direction of J.F. Geschwind, M.D., Director, Vascular and Interventional Radiology at The Johns Hopkins University School of Medicine The Johns Hopkins University School of Medicine, located in Baltimore, Maryland, USA, is a highly regarded medical school and biomedical research institute in the United States. . Patients will receive Avastin intravenously one week before and two weeks after undergoing a chemoembolization procedure. The study is designed to study the safety and efficacy of combining chemoembolization with Avastin in patients with advanced liver cancer. Avastin is a therapeutic monoclonal antibody designed to inhibit Vascular Endothelial Growth Factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature). (VEGF VEGF vascular endothelial growth factor. ), a protein that plays an important role in angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. , the formation of tumor blood vessel networks in response to injury or interference, such as a chemoembolization procedure. In order to grow or spread, tumors require a constant supply of oxygen and nutrients that the blood vessel networks supply. By inhibiting VEGF, Avastin is designed to interfere with the blood supply to a tumor. Richard Faleschini, BioSphere Medical's president and chief executive officer, said, "This is one example of BioSphere's objective to support physicians who use embolization in combination with cancer therapies and, we expect another important advance in treating the increasing global incidence of liver cancer. We are pleased to be aligned with Genentech, one of the industry's leading biotechnology companies; The Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. , one of the world's most respected health care and academic research institutions; and, Dr. Geschwind, a physician who is recognized internationally for his work in the field of interventional oncology." Gary Saxton, BioSphere Medical's EVP EVP Executive Vice President EVP EGR (Exhaust Gas Recirculation) Valve Position Sensor EVP Electronic Voice Phenomenon EVP Europäische Volkspartei (Germany) EVP Employee Value Proposition and chief operating officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. , commented, "Increasingly, interventional radiologists are managing complex diseases such as liver cancer. We are hopeful that combining chemoembolization with a novel investigational therapy will improve patient outcomes and advance our understanding of a disease that affects approximately 530,000 new patients worldwide each year." Chemoembolization is a two-stage process involving the injection of a concentrated dose of chemotherapeutic drugs directly into the blood vessels supplying a tumor, followed by the infusion of an embolic embolic /em·bol·ic/ (em-bol´ik) pertaining to an embolus or to embolism. em·bol·ic adj. 1. Relating to, or caused by an embolus or embolism. 2. Relating to emboly. agent -- such as BioSphere's patented, proprietary, bioengineered EmboSphere Microspheres -- through a catheter and into the blood vessels that feed a tumor, thus selectively blocking its blood supply. Because the blood vessels are blocked with the embolic material, the chemotherapy drug dwells in direct contact with the tumor longer and targets the tumor more effectively than a systemic chemotherapeutic treatment would. Thus, chemoembolization allows the drug concentration to be 20 to 200 times greater within the tumor than if the chemotherapy were injected into a vein in the arm. The side effects of chemoembolization are often less severe than the standard systemic chemotherapy because the drugs are trapped in the liver and are not circulated throughout the body. Mr. Faleschini concluded, "The Society of Interventional Radiology recently issued a position statement saying that 'chemoembolization is a safe, proven and effective technique for the treatment of a number of malignancies, including HCC HCC Hepatocellular Carcinoma (liver cancer) HCC Hertfordshire County Council (administrative region of south eastern England UK) HCC Harford Community College (Maryland) (hepatocellular carcinoma, a primary cancer that arises from the cells in the liver)... It has a palliative role for patients with colon carcinoma. It may be useful with patients who have hepatic-dominant metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. disease from other primary malignancies.' We are pleased that the initiatives we are pursuing for our cancer business are in alignment with the SIR's position statement, which underscores our intentions to continue to expand the clinical and commercial benefits of our microsphere Not to be confused with Glass microphere. This article largely refers to micropheres or protein protocells as small spherical units postulated by some scientists as a key stage in the origin of life. technology, both Embosphere Microspheres cited in this press release, and HepaSphere Microspheres, recently launched in the EU." The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved Avastin on February 26, 2004 as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. About BioSphere Medical, Inc. BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts, seeks to pioneer and commercialize minimally invasive diagnostic and therapeutic applications based on proprietary bioengineered microsphere technology. The Company's core technologies, patented bioengineered polymers and manufacturing methods, are used to produce microscopic spherical materials with unique beneficial properties for a variety of medical applications. BioSphere's principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization Uterine Fibroid Embolization Definition Uterine fibroids are growths in the muscular tissue of the womb (uterus). Uterine fibroid embolization is non-surgical removal of the growths through the use of a tubular device called a catheter. , or UFE UFE Uterine Fibroid Embolization UFE United for a Fair Economy UFE Ufficio Federale dell'Energia UFE Uniform Final Examination UFE Urban Challenge Final Event (DARPA) UFE Unidentified Flags and Ensigns UFE Unrestricted Free Agent . The Company's products continue to gain acceptance in this rapidly emerging procedure as well as in a number of other new and established medical treatments. Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, including statements regarding BioSphere's expectation that its embosphere technology will prove to be beneficial to addressing unmet needs in liver cancer, and that the Avastin clinical trial will improve patient outcomes and BioSphere's understanding of liver cancer. BioSphere uses words such as "believes," "may," "anticipates," "estimates," "expects," "should," "intend," and similar expressions to identify these forward-looking statements. There are a number of important factors that may affect BioSphere's actual results, many of which are beyond BioSphere's control and are difficult to predict. These important factors include, without limitation, risks relating to: the failure of BioSphere to obtain and/or maintain necessary regulatory approvals, either in the United States or internationally, with respect to the manufacture and sale of its EmboSphere Microspheres product and other products and product candidates; the failure of BioSphere to successfully achieve widespread market acceptance of its Embosphere Microspheres product in procedures for the treatment of liver cancer; risks relating to BioSphere's ability to obtain and maintain patent and other proprietary protection for its products and product candidates, including its EmboSphere Microspheres; competitive pressures; the inability of BioSphere to raise additional funds in the near term to finance its strategic initiatives; general economic and market conditions; and the risk factors described in the section titled " Risk Factors" in BioSphere's Quarterly Report on Form 10-Q for the quarter ended March 31, 2006, as filed by the Company with the Securities and Exchange Commission, and described in other filings made by the Company from time to time with the Securities and Exchange Commission. The forward-looking statements in this press release are made as of the date of this press release and the Company disclaims any obligation to update these forward-looking statements as a result of changed events, circumstances or otherwise. |
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