Celsion Completes Consultative Review Process With EMA for Phase III HEAT Study of ThermoDox(R) in Primary Liver Cancer
Confirms Regulatory Pathway for ThermoDox(R) in European Union
LAWRENCEVILLE, NJ -- (MARKETWIRE) -- 12/19/11 --
Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today that it has received written, scientific advice from the European Medicines Agency (EMA) confirming that the Company's Phase III HEAT Study, a multinational, double-blind, placebo controlled pivotal study of ThermoDox® in combination with radio frequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer, is acceptable as a basis for submission of a marketing authorization application (MAA).
Based on feedback and guidance received from the EMA, the Company expects that future results demonstrating a convincing magnitude of improvement in progression-free survival, the study's primary endpoint, along with a favorable benefit-risk ratio in the HEAT Study, would be sufficient as the primary basis for registration of ThermoDox® in Europe. The EMA also supported the Company's manufacturing strategy and technology transfer protocols, which will allow the Company to establish multiple manufacturing sites to support commercialization of ThermoDox® outside the United States.
"We are delighted with the advice and feedback from the EMA as it provides Celsion with confirmation that our HEAT Study is well designed and will serve as a basis for ThermoDox® approval," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Furthermore, we have a clear understanding on how best to design our nonclinical submission by following a similar course as our 505(b)(2) approach with the U.S. Food and Drug Administration. In addition to Orphan Drug Designation in Europe, received earlier this year, this positive outcome allows Celsion to move forward with a centralized filing in Europe and a clear regulatory pathway for product approval outside the U.S. A European approval provides
the basis for international filings in countries that require an approval from a globally recognized regulatory agency."
In March of this year, Celsion announced that the European Commission granted orphan drug designation for ThermoDox® in primary liver cancer, which provides assistance and incentives, including 10 years of marketing exclusivity subsequent to product approval, in support of product candidates intended for the treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union. ThermoDox® also holds orphan drug designation in the U.S.
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 26,000 cases per year in the United States, approximately 40,000 cases per year in Europe and is rapidly growing worldwide at approximately 700,000 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, 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly 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® and the Phase III HEAT Study
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. In the HEAT Study, ThermoDox® 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® is being evaluated in a 700 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® in combination with Radio Frequency Ablation (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. Additional information on the Company's ThermoDox® clinical studies may be found at www.clinicaltrials.gov.
About Celsion Corporation
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, the University of Pisa, and the North Shore Long Island Jewish Health System.
For more information on Celsion, visit our website: http://www.celsion.com.
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