LAWRENCEVILLE, N.J., Jan. 31, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that ThermoDox® in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase III HEAT Study in patients with hepatocellular carcinoma (HCC), also known as primary liver cancer.
Specifically, Celsion has determined, after conferring with its independent Data Monitoring Committee (DMC) that the HEAT Study did not meet the goal of demonstrating persuasive evidence of clinical effectiveness that could form the basis for regulatory approval in the population chosen for study. The HEAT Study was designed to show a 33% improvement in PFS with 80% power and a p-value = 0.05. In the trial, ThermoDox® was well-tolerated with no unexpected serious adverse events. The HEAT Study was conducted under a Special Protocol Assessment agreed to with the U.S. Food and Drug Administration (FDA).
"We are disappointed that the HEAT Study did not provide sufficient evidence of clinical effectiveness of ThermoDox® as measured by the trial's primary endpoint," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "We will consider following the patients currently enrolled in the HEAT Study to the secondary endpoint, Overall Survival (OS), and are conducting additional analyses of the data from the trial in order to assess the future strategic value of ThermoDox. We expect that the results will be presented in the future at appropriate medical meetings. We wish to acknowledge and thank the patients and investigators who participated in the trial."
Celsion ended 2012 with a strong balance sheet that provides the Company the opportunity to evaluate its future development plans. The Company projects its unaudited cash and investment balance to be approximately $23 million as of December 31, 2012 and approximately $27 million as of January 31, 2013.Conference Call The Company is hosting a conference call to discuss the Phase III HEAT Study results at 8:00 a.m. EST today. To participate in the call, interested parties may dial 1-888-466-4462 (Toll-Free/ North America) or 1-719-457-2627 (International/Toll) and ask for the Celsion Corporation Phase III HEAT Study Conference Call approximately 10 minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at http://www.celsion.com. The call will be archived for replay at 2 p.m. EST on January 31, 2013, and will remain available until February 14, 2013. The replay can be accessed at 1-877-870-5176 (Toll-Free/ North America) or 1-858-384-5517 (International/Toll) using Conference ID: 4540212. An audio replay of the call will also be available on the Company's website, http://www.celsion.com, for 30 days after 2p.m. EST on Thursday, January 31, 2013.