Columbia, MD January 3, 2007: CELSION CORPORATION (AMEX: CLN) today reported that in an article published in the Journal of the National Cancer Institute, on January 3, 2007, Duke University scientists reported results of a recent study using Celsion's temperature sensitive liposomes in combination with heat at various times during the drug infusion .
Previous preclinical studies using heat activated liposomes in combination with local hyperthermia had demonstrated increased tumor effect compared to non-temperature sensitive liposomes or free drug. It was suggested that due to the rapid content release at 41.3ºC the drug distribution may be affected by the timing of the temperature application. In the reported study, doxorubicin and a MRI contrast agent were encapsulated in Celsion's heat activated liposome. These liposomes in combination with heat were used to evaluate relationships between temperature profile, drug distribution and anti-tumor activity in a rat tumor model.
In the study the scientists found that during the heat activated liposome administration the time at which the heat was applied could be used to control the amount of drug delivered to different areas of a tumor and its anti-tumor efficacy. Doxorubicin accumulated more quickly and reached higher concentrations in the tumor when the heat was applied simultaneously with the drug administration when compared to application of heat prior to the infusion. Simultaneous administration also produced the greatest anti-tumor effect. Heat applied before and during the heat activated liposome infusion produced a uniform distribution of doxorubicin within the tumor, whereas doxorubicin was only found in the periphery of the tumor when heat was applied during the liposome administration. Since the periphery also contains the blood vessels supplying the tumor, the greatest anti-tumor activity produced by the simultaneous administration of heat and heat activated liposome is probably due to the effect of doxorubicin on the tumor blood vessels.
Lysolipid-containing temperature sensitive liposomes were invented by Dr. David Needham, Professor, Mechanical Engineering and Material Sciences at Duke University. Celsion has licensed global rights to the technology and is currently using a heat activated liposome containing doxorubicin (ThermoDox™) in Phase I clinical studies in liver cancer and recurrent chest wall breast cancer, the latter study being performed at Duke University where Dr. Kim Blackwell is the principal investigator. Celsion is working with the FDA to finalize endpoints for a Phase III study in primary liver cancer and expects to initiate enrollment in this study in 2007.
Dr. William Hahne, Celsion's Vice President of Research and Development, commented "These studies provide further confirmation of our in-vivo data suggesting increased drug delivery from our heat activated liposomes to the heated area. We are convinced that our technology will prove to be a valuable tool in the continued fight against cancer. This work generated by Drs. Ponce and Dewhirst will be used to refine tumor targeting and ultimately to improve the efficacy of drugs using our heat activated delivery system."
The Prolieve Thermodilatation system is a minimally invasive transurethral microwave system which combines a transurethral microwave thermotherapy device with pressure applied by a balloon catheter.
Prolieve is marketed, in the United States, under an exclusive distribution agreement, with Boston Scientific Corporation.
Celsion has research, license or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, Massachusetts Institute of Technology, Harbor UCLA Medical Center, Montefiore Medical Center and Memorial Sloan-Kettering Cancer Center in New York City, Roswell Park Cancer Institute in Buffalo, New York, and Duke University. For more information on Celsion, visit our website: http://www.celsion.com.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, 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.
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