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Celsion receives DMC recommendation to continue with phase 3 liver cancer trial

Celsion receives DMC recommendation to continue with phase 3 liver cancer trial

Celsion Corp (NASDAQ:CLSN) said Monday it received a unanimous recommendation from the independent data monitoring committee (DMC) to continue with its phase three study of ThermoDox, intended for the treatment of primary liver cancer.

The phase three study is a multinational, double-blind, placebo-controlled study that examines the effect of Celsion's ThermoDox drug, in combination with radiofrequency ablation treatment (RFA).

The trial recently finished an interim break to analyze the safety, efficacy and futility of the treatments, at which point the DMC recommended that the study continue to its final analysis as planned.

The DMC evaluated data from 613 patients, 219 of which achieved progression-free survival (PFS). A total of 380 PFS events are required to reach the planned final analysis of the study. the company said.

"The DMC's unanimous recommendation is a significant achievement for Celsion based on the most comprehensive review of the study to date, including the first-ever review of efficacy results," said president and CEO, Michael H. Tardugno.

"Critically, we have the potential to realize a successful outcome to the study prior to its planned completion.

"We are encouraged by what may be sufficient rationale for conducting an additional preplanned efficacy review prior to the 380 events called for in our protocol, and will seek to amend our Special Protocol Assessment Agreement with the FDA accordingly."

Primary liver cancer is the fifth most common solid tumour cancer. About 700,000 new cases are diagnosed globally each year, largely stemming from the high occurrence of Hepatitis B and C in developing countries.

The standard treatment for this type of cancer is the surgical removal of the tumour, though 90 percent of patients are ineligible for this treatment option. RFA has become a common standard of care, though it becomes less effective as the size of the tumour increases.

Celsion's ThermoDox product is a proprietary heat-activated formulation of doxorubicin, a common chemotherapeutic agent. The drug is encapsulated in a liposomal shell, and is only released when heated through the RFA treatment.

This delivery technique allows the drug to be delivered in a high dose specifically to the targeted tumour, reducing the impact of the drug on surrounding healthy cells.

The phase three study is being conducted under a U.S. FDA Special Protocol Assessment, after receiving a fast track designation in August 2010.

Celsion is continuing to enroll at least 200 patients in China, a requirement for the country's State Food and Drug Administration.

The company said it expects to conduct additional interim efficacy analyses before it reaches the planned 380 PFS events, targeted for the end of 2012.



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