Celsion Corp(NASDAQ:CLSN) , a leading oncology drug development company, today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on the application for Orphan Drug Designation for ThermoDox(R), a proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. A positive opinion by the COMP immediately precedes official designation of ThermoDox(R) as an orphan drug by the EMA. ThermoDox(R) is currently being evaluated under a Special Protocol Assessment with the FDA in a 600 patient pivotal Phase III trial (the HEAT study) in patients with non-resectable primary liver cancer at 76 clinical sites in 11 different countries. ThermoDox(R) has previously received Orphan Drug designation by the U.S. Food and Drug Administration (FDA). In addition, the HEAT study has been designated as a Fast Track Development Program by the FDA.
Orphan designation for a medicinal product by the EMA provides for scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, and certain financial incentives. The designation also provides 10 years of marketing exclusivity subsequent to product approval. Orphan drugs are eligible for full reduction of fees associated with pre-authorization inspections, as well as full reduction of marketing application fees and annual fees for qualifying companies.
"We are very pleased to receive a positive opinion from the Committee for Orphan Medicinal Products, which immediately precedes final Orphan Drug designation from the EMA, for ThermoDox(R)," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer. "This positive opinion on our application for orphan designation status is an acknowledgement of the significant unmet medical need to develop a new treatment for patients with primary liver cancer, a life threatening disorder for which today there is no effective chemotherapeutic standard of care. Centralized approval provides for rapid commercialization across the European Union. We look forward to continuing our positive interactions with the EMA, the FDA and other regulatory agencies around the world to make ThermoDox(R) available to patients as soon as possible."
Regulatory agencies around the world, as well as the liver cancer medical community, have all recognized the potential of ThermoDox(R) for the treatment of this unmet medical need as evidenced by the following:
Orphan Drug designation for ThermoDox(R) by the FDA and a positive opinion by the COMP for similar designation in Europe;
The HEAT study has been granted a Fast Track Designation by the FDA; and
The National Cancer Institute's recent designation of the HEAT study as a Priority Clinical Trial at its recent Clinical Trial Planning Meeting for HCC.
About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States, approximately 40,000 cases per year in Europe and is rapidly growing worldwide at approximately 750,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries. The standard first line treatment for liver cancer is surgical resection of the tumor; however 80% to 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasing become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.
About ThermoDox(R) and the Phase III HEAT Study
ThermoDox(R) 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. In the HEAT study, ThermoDox(R) is administered intravenously in combination with RFA. Localized mild hyperthermia (39.5-42 degrees Celsius) created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
For primary liver cancer, ThermoDox(R) is being evaluated in a 600 patient global Phase III study at 76 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox(R) in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the trial is complete and 190 PFS events are realized in the study population. Additional information on the Company's ThermoDox(R) clinical studies may be found at http://www.clinicaltrials.gov
Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer 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, 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.
Investor Contact Marcy Nanus The Trout Group 646-378-2927, email@example.com
SOURCE Celsion Corporation
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