COLUMBIA, Md., Jan. 21 /PRNewswire-FirstCall/ -- CELSION CORPORATION (Nasdaq: CLSN) today announced the ThermoDox® liver cancer abstract "A Phase I Trial of ThermoDox in Patients Undergoing Radiofrequency Ablation (RFA) of Liver Tumors" has been accepted for oral presentation at the 9th World Congress of the International Hepato-Pancreato-Biliary Association (IHPBA) http://www.ihpba-ba2010.com/ to be held April 18-22, 2010, in Buenos Aires, Argentina.
This world congress, hosted every two years in different international locations, is attended by more than 1,200 medical professionals throughout the world who specialize in liver cancer and the latest treatment options. The study was conducted by and will be presented by Thanjavur S. Ravikumar et. al. of North Shore-Long Island Jewish Hospital, Manhasset, New York. Dr. Ravikumar is currently Director-Cancer Services, Chief Quality Officer-surgery/interventional procedures, and Director-Center for surgical innovation; Geisinger Health System, PA, and continues his work with ThermoDox and RFA as a clinical investigator in Celsion's HEAT study.
In this Phase I study, ThermoDox was assessed for safety, pharmacokinetics and tumor response in 12 liver cancer patients (3 with hepatocellular carcinoma (HCC) and 9 with metastatic cancer). Patients were treated with ThermoDox (doses ranged from 30- 50mg/m2) during radiofrequency ablation (RFA), an accepted treatment procedure for unresectable liver tumors.
Dr. Ravikumar commented, "data from the study demonstrated excellent toxicity and tumor response profiles when combining ThermoDox with RFA and shows the potential for local control of tumors by releasing high concentrations of doxorubicin within the surrounding tumor margins." Conclusions from the Phase I study provided support for Celsion's global Phase III trial in patients with HCC.
The rapid increase in primary liver cancer incidence worldwide, now at more than 650,000 cases, needs to be addressed by more aggressive treatments. ThermoDox is being studied as a potential first line treatment in combination with RFA in the pivotal Phase III HEAT trial. The study, which was agreed to under Special Protocol Assessment (SPA) guidance with the FDA provides progression free survival as its primary endpoint for accelerated review and is designed to demonstrate local tumor control with an overall survival benefit. The HEAT trial is a two arm, 1 to 1 randomized study comparing RFA with ThermoDox to SFA alone with a study population of 600 patients.
"This will be the second time that an oral presentation of ThermoDox in combination with RFA has been accepted by the IHPBA and is a clear indication of the medical community's interest in the progress of our clinical research and the promise for ThermoDox to provide an effective treatment for hepatocellular carcinoma. With the support of our global investigators, the HEAT study is reaching its half way point with over 250 patients treated. The initiation of clinical sites in China, Thailand, Malaysia and the Philippines supplies the momentum for our target to complete enrollment by mid-year," stated Michael H. Tardugno, Celsion's President and Chief Executive Officer.
ThermoDox in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox is a proprietary, heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of 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.
ThermoDox has demonstrated evidence of efficacy in a Phase I study for primary liver cancer and the FDA has granted Orphan Drug designation for this indication. For recurrent chest wall breast cancer, ThermoDox is being evaluated in a pivotal Phase I/II open-label, dose-escalating trial that is designed to measure durable local complete response at the tumor site.
ThermoDox(R) is a registered trademark of Celsion Corporation
About Primary Liver Cancer
Primary liver cancer (hepatocellular carcinoma, HCC) is a type of cancer that begins in the cells of the liver and is not typically detected early, often resulting in a poor patient prognosis. Mortality among primary liver cancer patients is one of the world's highest and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer in the USA is approximately 20,000 cases per year and is rapidly growing worldwide. Globally there are more than 650,000 cases per year, with the major risk factor being Hepatitis B and C in high prevalence in developing countries. There are few non-surgical therapeutic treatment options available as radiation and chemotherapy are largely ineffective in the treatment of primary liver cancer. The standard first line treatment for liver cancer is surgery, either resection or liver transplantation, but 70% to 80% of patients are ineligible for surgery. Radio frequency ablation (RFA), with limitations, has shown to be effective and has increasingly become the standard of care for non-resectable liver disease. Celsion is evaluating its lead drug, ThermoDox, in combination with RFA to improve the range and efficacy of the RFA procedure to treat this difficult disease.
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has licensed ThermoDox(R) to Yakult-Honsha for the Japanese market and has a partnership agreement with Phillips Medical to jointly develop its heat activated liposomal technology in combination with high intensity focused ultrasound to treat difficult cancers. 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, and the 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.
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