Liver Phase I Abstract Presented at 8th World Congress of IHPBA
The IHPBA is hosting this Congress in Mumbai, India from February 27th to March 2nd, 2008. http://www.ihpba2008.com. This bi-annual international Congress is the largest in its history, with over 1,600 leading faculty and researchers attending from nearly 65 countries, and provides global perspectives on the standard of care and latest treatment options for liver and pancreatic cancers.
The presentation, titled "Phase I Study of ThermoDox (Thermally Sensitive Liposomes Containing Doxorubicin) Given Prior to Radiofrequency Ablation for Unresectable Liver Cancers," was delivered by Dr. Ronnie T. Poon, MD, Professor of Surgery, Faculty of Medicine at Queen Mary Hospital, University of Hong Kong. A clinical study summary of the 24 patients was provided. Dr. Poon commented, "The completion of this study enabled us to draw several valuable clinical conclusions. Specifically, the dose of 50 mg/m(2) is both safe and tolerable for use in the Phase III study." He further indicated that any data from this study that may be suggestive of clinical activity should be conclusively determined in the upcoming randomized controlled study. Dr. Poon concluded, "I am looking forward to initiating Celsion's Phase III study at the Queen Mary Hospital and to my role as Principal Investigator for the Asian study sites."
This Phase I study which was carried out at the National Cancer Institute (NCI) of the National Institutes of Health, under the leadership of Dr. Steven K. Libutti, Senior Investigator, Head, Tumor Angiogenesis Section, Surgery Branch, Center for Cancer Research, NCI and Dr. Bradford J. Wood, Chief, Interventional Radiology Research at the National Institutes of Health Clinical Center and at Queen Mary Hospital in Hong Kong under the leadership of Dr. Ronnie T. P. Poon, MD, Professor of Surgery, Faculty of Medicine at Queen Mary Hospital, University of Hong Kong. In the study, a total of 24 primary and metastatic liver cancer patients, with up to 4 lesions ranging from 3 to 7 centimeters, were treated with ThermoDox in combination with radiofrequency ablation at doses ranging from 20 to 60 mg/m(2).
Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented, "The selection for Oral Abstract presentation at the Awards Session to this large distinguished audience is particularly meaningful to us. In addition to communicating supportive results, we have aligned with investigators who have taken a particular interest in the promise of ThermoDox for the treatment of primary liver cancer, and share our interest in offering this novel therapy to patients suffering from this life threatening disease. We congratulate the ThermoDox investigators from the National Cancer Institute and Queen Mary Hospital for their hard work and dedication. This published abstract is an important milestone in the development of ThermoDox for the liver cancer population. We now look forward to launching our global Phase III study of ThermoDox for hepatocellular carcinoma in the immediate near-term."
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 including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) 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.
Contact
Cameron Associates
Paul G. Henning, 212-554-5462
phenning@cameronassoc.com
Posted: February 2008
