Data Safety Monitoring Board Recommends Continuation Of Celsion's Phase III ThermoDox(R) Study For Primary Liver Cancer

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials;  Cancer / Oncology
Article Date: 22 Sep 2009 - 5:00 PDT

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Celsion Corporation (NASDAQ:CLSN) announced the Data Safety Monitoring Board ("DSMB") has reviewed the safety data from the first group of patients enrolled in its pivotal ThermoDox® Phase III clinical trial for primary liver cancer ("HEAT study") and has recommended that Celsion continue to enroll patients in the trial.

The DSMB for the ThermoDox HEAT study is comprised of an independent group of medical and scientific experts who are responsible for reviewing and evaluating patient safety and efficacy data. The DSMB reviews safety data at regular intervals and its charter is to ensure patient safety and monitor the quality and overall conduct of the study. The study design and statistical plan for the Phase III ThermoDox trial also incorporates a pre-planned interim efficacy analysis by the DSMB after patient enrollment is complete with the intent to stop the study if there is overwhelming evidence of treatment benefit or an extremely low probability of treatment success.

Michael H. Tardugno, President and Chief Executive Officer of Celsion stated, "We are pleased that the DSMB has recommended continuing the study based on its review of the safety data. We expect patient enrollment to continue to accelerate, as the trial was recently expanded to Japan in coordination with our exclusive Japanese license partner Yakult. We note that under our partnership, Yakult will bear all costs associated with the Japanese cohort. Additionally, Celsion anticipates that regulatory approval for new clinical sites in China is imminent. Together with the expected activation of sites in Malaysia, the Philippines, and Thailand, the Company projects 60 sites by year end. We expect to complete enrollment in the spring of 2010."

Celsion's global Phase III ThermoDox study for primary liver cancer is enrolling 600 patients and is being conducted under a FDA Special Protocol Assessment (SPA). The study is designed to evaluate the efficacy of ThermoDox 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. Additional information on the ThermoDox Phase III clinical study may be found at http://www.clinicaltrials.gov.

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 and is rapidly growing worldwide at approximately 1,000,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries. Among the standard treatment options for liver cancer is surgical resection of the tumor; however 80% to 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.

About ThermoDox®

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. ThermoDox® is administered intravenously and in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. Localized mild hyperthermia (39.5-42 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 already demonstrated remarkable evidence of clinical activity in Phase I studies for primary liver cancer and recurrent chest wall breast cancer. For the primary liver cancer indication, Celsion has been granted FDA Orphan Drug designation. For recurrent chest wall breast cancer, ThermoDox(R) 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. Celsion expects to enroll approximately 100 patients in the U.S. within calendar year 2010

ThermoDox(R) is a registered trademark of Celsion Corporation

Source
Celsion