Celsion Receives FDA Approval for Phase I Breast Ablation Trials At Two New Sites.COLUMBIA, Md.--(BW HealthWire)--Aug. 16, 1999-- -- Evaluation to be Accelerated via Studies to be Conducted at UCLA and Columbia (FL) -- Celsion Corp. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB:CELN) today announced that it has received approval from the U.S. Food and Drug Administration (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. ) to commence Phase I clinical studies at two new sites to evaluate the Company's focused heat breast cancer treatment This article or section recently underwent a major revision or rewrite and needs further review. You can help! The mainstay of breast cancer treatment is surgery when the tumor is localized, with possible adjuvant hormonal therapy (with tamoxifen or an aromatase system. To expedite patient accrual, the Company explained, trials are planned at Columbia Hospital in West Palm Beach, Florida West Palm Beach, also known as West Palm, is the most populous city in Palm Beach County, Florida, USA. The city is also the oldest incorporated municipality in South Florida. According to the University of Florida's 2006 estimates, the city had a population of 107,617. , a member of Columbia/HCA Healthcare Corp., and Harbor UCLA Medical Center UCLA Medical Center is a hospital located on the campus of the University of California, Los Angeles in Los Angeles, California. It is rated as one of the top three hospitals in the United States and is the top hospital on the West Coast according to US News & World Report. in Torrance, California. Celsion said the studies should begin as soon as the hospitals receive internal approval. Investigators: The principal investigator of the Phase I clinical evaluations is Dr. Hernan Vargas, Chief of Surgical Oncology at Harbor UCLA Medical Center. The three co-investigators are Dr. Jerome Block, Professor of Medicine and member of the Division of Medical Oncology and Hematology at Harbor UCLA, Dr. Robert Gardner, Chief of the Center for Breast Surgery at Columbia Hospital, and Dr. Charles Vogel, Medical Director of Columbia Cancer Research Network. Celsion hopes to evaluate the ability of its breast cancer treatment focused heat technology to destroy cancerous tumors and viable cancer cells in humans using heat alone. The device is designed to provide non-surgical, minimally invasive treatment and is hoped to be non-toxic and side effect free. MIT Origin of Technology: The Company's breast cancer treatment incorporates a focused heat system developed by Celsion using proprietary technologies licensed exclusively from several engineering and medical research institutions. This includes the Adaptive Phased Array (APA) focusing technology, which the Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, (MIT) designed for the U.S. Department of Defense Star Wars Initiative that Celsion has adapted with the intent of focusing microwave heat on tumors while leaving healthy skin and surrounding tissue unharmed. Celsion Corporation is a research and development company dedicated to commercializing medical treatment systems for cancer and benign prostatic hyperplasia benign prostatic hyperplasia n. Abbr. BPH A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine. using focused heat delivered by patented microwave technology. Clinicals and further development of the Company's treatment systems are being conducted by leading institutions such as the Columbia Hospital (a Columbia/HCA Healthcare member), Duke University, Harbor UCLA Medical Center, Massachusetts Institute of Technology, and Montefiore Medical Center Montefiore Medical Center, in the Bronx, New York, is the university hospital of the Albert Einstein College of Medicine. The hospital, named after Moses Montefiore, is one of the 50 largest employers in New York State [1]. . Forward-looking statements in this release are made pursuant to the "safe harbor" provisions 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. Investors are cautioned that such forward-looking statements involve risks and uncertainties, including, without limitation, possible changes in cost of materials, expense items, capital expenditures, capital structure, and other financial items; introduction of new products and possible acquisitions of assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion