To: hoyasaxa who wrote (15 ) 8/16/1999 2:01:00 PM From: Tech Master Respond to of 20
Monday August 16, 1:01 pm Eastern Time Company Press Release Celsion Receives FDA Approval for Phase I Breast Ablation Trials At Two New Sites -- Evaluation to be Accelerated via Studies to be Conducted at UCLA and Columbia (FL) -- COLUMBIA, Md.--(BW HealthWire)--Aug. 16, 1999-- Celsion Corp. (OTC BB:CELN - news) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to commence Phase I clinical studies at two new sites to evaluate the Company's focused heat breast cancer treatment system. To expedite patient accrual, the Company explained, trials are planned at Columbia Hospital in West Palm Beach, Florida, a member of Columbia/HCA Healthcare Corp., and Harbor UCLA Medical Center 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 (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 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. Forward-looking statements in this release are made pursuant to the ''safe harbor'' provisions of the Private Securities Litigation Reform Act 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.