Celsion (CLSN) Says Independent DMC Recommends Continuation of HEAT; Fast Track Designation Given

September 14, 2012 8:15 AM EDT
Celsion Corporation (Nasdaq: CLSN) announced that the independent Data Monitoring Committee (DMC) for the Company's HEAT Study, a fully enrolled, multinational, double-blind, placebo-controlled, pivotal Phase III trial of ThermoDox in combination with radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC or primary liver cancer), has completed a regularly scheduled review of all 701 patients enrolled in the trial and has unanimously recommended that the HEAT Study continue according to protocol to its final data readout. The HEAT Study is being conducted under a Special Protocol Assessment (SPA) agreed to with the U.S. Food and Drug Administration (FDA).

The primary endpoint for the HEAT Study, progression-free survival (PFS), is defined in the SPA. A total of 380 PFS events are required to reach the unblinding and planned final analysis of the study. Celsion reconfirmed that 380 PFS events are projected to occur in the fourth quarter of 2012, with top line results announced following DMC review and confirmation.

The DMC has reviewed study data at regular intervals, with the primary responsibilities of ensuring the safety of all patients enrolled in the study, the quality of the data collected, and the continued scientific validity of the study design. As part of its review of all 701 patients, the DMC monitored a quality matrix relating to the total clinical data set, confirming the timely collection of data, that all data are current as well as other data collection and quality criteria.

The HEAT Study, in addition to being conducted under an FDA Special Protocol Assessment, has received FDA Fast Track Designation and has been designated as a Priority Trial for liver cancer by the National Institutes of Health. ThermoDox has been granted orphan drug designation in both the U.S. and Europe. The European Medicines Agency (EMA) has confirmed the HEAT Study provides an acceptable basis for submission of a marketing authorization application (MAA) for centralized review and approval. In addition to meeting the U.S. FDA and European EMA enrollment objectives, the HEAT Study has also enrolled a sufficient number of patients to support registrational filings in China, South Korea and Taiwan, three other large and important markets for ThermoDox.

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