Monday November 15, 9:05 am Eastern Time
Company Press Release
Duke University Grants Celsion Exclusive License for Heat-sensitive Liposome Technology for Treatment of Cancer
-- Duke Willing to Accept Milestone Payments in Celsion Common Stock --
COLUMBIA, Md.--(BW HealthWire)--Nov. 15, 1999-- Celsion Corporation (OTC BB:CELN) today announced that it has signed an exclusive license agreement for the commercial rights to utilize Duke's proprietary heat- sensitive liposome technology (patent pending) for targeted delivery of drugs in the treatment of cancer and other diseases. If successfully developed and proven in human clinical trials, these second generation heat-sensitive liposomes may lead to significant improvement in effective delivery of chemotherapeutic drugs to fight cancer. The company said that Duke has agreed to accept shares of Celsion's Common Stock in lieu of cash for milestone payments under the terms of the agreement.
How Heat-Sensitive Liposomes Work
Duke and Celsion intend to initially focus on using the heat sensitive liposome technology in a ''targeted drug delivery approach'' for cancer treatments. For example, when heat-sensitive liposomes encapsulating cancer drugs are injected into a patient, they travel passively to the tumor site which has been heated to a few degrees above body temperature. The temperature rise triggers the liposomes to release their encapsulated drugs in tens of seconds at the treatment area. Traditional liposomes are not thermally-sensitive and so cannot be triggered to release their drug contents in tumors. Preclinical evaluations of liposomal systems in animals demonstrate that hyperthermia itself leads to the deposition of 50 times more drug in tumors than without heating. The heat-triggered, and rapid release properties of these new thermally-sensitive liposomes, that have also been designed to release drugs at clinically attainable hyperthemic temperatures, are expected to significantly increase drug concentration at the tumor site, thus improving efficacy and reducing toxicity to other parts of the body. The safety and efficacy of this ''targeted and triggerable drug delivery approach'' must first be demonstrated in patients before commercialization. The Company intends to make application to the FDA to allow clinical trials after additional pre-clinical tests are performed.
Opportunities
Under this license, Celsion holds the exclusive right to develop medical treatment products based on the use of Duke's heat triggered delivery technology. Celsion also holds the exclusive commercial rights to develop deep focused heat systems for tumors anywhere within the human body, based on patented adaptive phased array technology developed by the Massachusetts Institute of Technology.
Dr. Needham, Professor in the department of Mechanical Engineering and Materials Science at Duke University and the inventor of the heat-sensitive technology, said ''This agreement with Celsion represents an essential next step in the testing of our themally-sensitive liposomes, and we are extremely delighted that Celsion is keen to move rapidly into clinical trials, and bring this new and promising combination technology to the patient.''
''We are pleased to continue our partnership with Celsion and are greatly encouraged by early results of the heat-sensitive, lipid-based, targeted drug delivery system presently under development,'' said Dr. Mark Dewhirst, Professor of Radiation Oncology at Duke University Medical Center.
''We are very hopeful that pharmaceutical firms will be able to implement the systems to optimize the efficacy of toxic drugs and greatly reduce undesirable side effects,'' Dr. Dewhirst continued. ''This in turn could create a significant opportunity for promising new drugs that may have otherwise been deemed too toxic for commercialization.''
Celsion Corporation is a research and development company dedicated to commercializing medical treatment systems for cancer and other diseases 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, Duke University Medical Center, 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. |