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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."
The Company implemented a restructuring program to lower its operating costs to conserve capital. The program includes elimination of approximately one-third of Celsion's workforce and the deferral of expenses associated with the Company's Phase II study of ThermoDox
® in combination with RFA for the treatment of colorectal liver metastases (The ABLATE Study). Celsion expects these measures to remain in effect until such time as it finalizes its plans for the continuation of its development program with ThermoDox® in HCC. Celsion ended the first quarter of 2013 with approximately
$46 million in cash and investments. Ongoing salary costs, net of restructuring costs, are expected to reduce overall operating expenses during the current fiscal year.
"While it is difficult to eliminate positions in our talented and dedicated workforce, this move is necessary to ensure that our costs are adequately aligned with our resources and business strategy," Mr. Tardugno said. "We are reducing expenses in all areas, but we are doing this with an eye toward limiting the impact on our future development programs for ThermoDox® as well as afford us the opportunity to identify and develop new product candidates
."Engagement of Financial Advisor to Evaluate Acquisition Alternatives
The Company has engaged Cantor Fitzgerald & Co. to conduct a comprehensive review of merger and acquisition opportunities with the goal of identifying novel products with high potential, or companies, for Celsion to acquire. Strategic alternatives the Company may pursue could include, but are not limited to, continuing its current operating plan, partnering or other collaboration agreements, acquisition of another company's business or assets, or a merger or other strategic transaction. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. The Company does not intend to disclose developments with respect to this process except as required under applicable securities regulations.