August 28, 2008
ThermoDox(R) Liver Cancer Study Phase I Results to Be Presented at ILCA Conference 2008
CELSION CORPORATION (NASDAQ: CLSN) announced today that the interim results from its second Phase I liver cancer confirmation study of ThermoDox(R) used in combination with Radio Frequency Ablation (RFA) for the treatment of patients with primary and metastatic liver cancer will be presented at a Poster Presentation session at the International Liver Cancer Association (ILCA) Annual Conference in Chicago, IL, from September 5-7, 2008. This annual conference is recognized as a premier multidisciplinary gathering of cancer researchers dedicated to the exchange of knowledge and innovative approaches to liver cancer research and care. For more information on the ILCA, visit their website: http://www.ilca-online.org/.
The abstract presentation, titled "Phase I Dose Escalation Study of Thermally Sensitive Liposomal Doxorubicin (ThermoDox(R)) in combination with Radiofrequency Ablation (RFA) of Primary and Metastatic tumors to the liver: Interim Report" will be delivered by Dr. Thanjavur S. Ravikumar, MD Professor and Chairman, Department of Surgery, North Shore Hospital, Albert Einstein Medical School. The presentation will provide interim Phase I results regarding safety, dosage and pharmacokinetic summaries supporting the company's pivotal global trial for Hepatocellular Carcinoma, which is currently enrolling patients.
The ILCA Annual Conference 2008 marks the fifth time this year that Phase I results from ThermoDox(R) trials have been presented at a major medical conference. In February of this year, Dr. Ronnie T. Poon, Professor of Surgery at the Queen Mary Hospital, Hong Kong presented our Phase I liver cancer study results at the International Hepato-Pancreato-Biliary Association (IHBPA) Conference in Mumbai, India at the Oral Paper Awards Session. In March, Dr. Bradford J. Wood's abstract titled "Imaging Features in Patients undergoing Liver RFA plus Heat Deployed Nanoparticles" was selected for Oral presentation at the Society for Interventional Radiology. Also in March, Dr. Zeljko Vujaskovic, Associate Clinical Professor at Duke University, on behalf of Dr. Ellen Jones, presented interim progress and evidence of safety and suggested efficacy from our second indication under study, Recurrent Chest Wall breast cancer, at the ICHO Conference in Munich, Germany. Finally, in June Dr. Ravikumar presented at WCIO 2008 & Best of ASCO.
Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented, "The medical and scientific communities' interest in our innovative treatment approach and the results that ThermoDox(R) has shown in early phase trials is most encouraging and reinforces our commitment to bringing our promising technology to market as rapidly as possible. Accordingly, we continue to make progress in our pivotal Phase III HCC program. We have enrolled patients in four out of the seven countries for which we have Clinical Trial Agreements and have announced our plans for clinical development in Japan, funded and led by Yakult Honsha. Yakult is a leading Japanese healthcare company with a rapidly growing oncology focus. Through this partnership agreement, our goal is to ensure ThermoDox(R)'s presence in the promising Japanese HCC market, which is currently the 2nd largest global market based on incidence."
About ThermoDox(R): ThermoDox(R) is Celsion's proprietary heat-sensitive liposomal encapsulation of doxorubicin, an approved and frequently used anti-cancer drug used in the treatment of various cancers. Localized heat (at 40-42 degrees Celsius and above) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
About Celsion: Celsion is dedicated to the development and commercialization of oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has research, license or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, North Shore Long Island Jewish Health System.
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.