Today : Tuesday 23 April 2013
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LAWRENCEVILLE, N.J., April 23, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) today is providing a business update, including the latest findings from its analysis of clinical trial results for ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin. Celsion is evaluating ThermoDox® in a Phase III clinical trial for primary liver cancer (the HEAT Study), a Phase II clinical trial for colorectal liver metastasis and a Phase II clinical trial for recurrent chest wall breast cancer.
Phase III HEAT Study Data Analysis
The Company has conducted a comprehensive analysis of the data from the Phase III HEAT Study with key principal investigators, data experts and liver cancer experts. This follows the announcement on January 31, 2013, that ThermoDox® in combination with radiofrequency ablation (RFA) did not meet the study's primary endpoint. Emerging data from the HEAT Study post analysis demonstrates that ThermoDox® markedly improves progression free survival (PFS) and overall survival (OS) in patients who had optimal RFA. The analysis indicates that if patients' lesions undergo RFA for 45 minutes or more, they clearly benefitted from ThermoDox®. These findings apply to HCC lesions from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a sizable subgroup of patients. This data is subject to further verification and review by the HEAT Study Steering Committee.
"We have completed a thorough review of the HEAT Study and there is clear evidence that ThermoDox® can benefit patients when RFA is optimized," said Dr. Nicholas Borys, Celsion's Vice President and Chief Medical Officer. "These data are very exciting and consistent with the mechanism of ThermoDox® activity."
Michael Tardugno, Celsion's Chief Executive Officer, added, "Based on the strength of these findings, the Company will request a meeting with regulatory authorities for guidance on moving forward with our HCC development program. We plan to disclose the details of the HEAT Study data at upcoming medical meetings and in a peer-reviewed publication. We will provide updates on these activities when appropriate."