Celsion Corporation, a leading oncology drug development company, announced that it has reached its pre-planned enrollment objective of 600 patients in the company’s Phase 3 HEAT study, a multinational, randomized, double-blind, placebo-controlled clinical trial of ThermoDox in combination with radio frequency ablation (RFA) for the treatment of primary liver cancer. The enrollment objective was established to ensure that the study’s primary end point, progression-free survival (PFS), can be achieved with adequate statistical power and is one of two triggers for an interim efficacy analysis by the study’s independent Data Monitoring Committee (DMC). The second trigger is the confirmation of 190 PFS events in the study population. The HEAT study is being conducted under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, has received FDA Fast Track Designation, and has been designated as a Priority Trial for primary liver cancer by the National Institutes of Health.
“This milestone is a significant accomplishment for the Celsion team and our many collaborators in the global oncology community. Reaching our enrollment objective is also a critical step toward establishing ThermoDox’s potential as a new standard of care in the first line treatment of non-resectable primary liver cancer,” said Michael H. Tardugno, President and Chief Executive Officer of Celsion. “As this potential becomes clearer in the coming months, Celsion will take steps toward ensuring a seamless commercialization process for ThermoDox and the expansion of its clinical development into other indications where it may enhance the efficacy of thermal-based oncology therapies, including recurrent chest wall breast cancer as well as metastatic liver and bone cancers. With this accomplishment, Celsion remains firmly on a path toward its evolution into a leading oncology drug development company.”
“The HEAT study is the largest clinical trial ever conducted in intermediate hepatocellular carcinoma (HCC) and its outcome is greatly anticipated within the medical community. HCC is an aggressive, deadly disease, and one of a few cancers that is growing at an alarming rate throughout the world,” added Nicholas Borys, MD, Celsion’s Chief Medical Officer. “We believe that adding ThermoDox to a RFA procedure will dramatically increase the hope for a cure.”
The design and statistical plan of the HEAT study incorporate a pre-planned interim efficacy analysis. The HEAT study’s independent Data Monitoring Committee will evaluate the unblinded data after the 600 patient target enrollment is reached and 190 PFS events are realized in the study population. The DMC is comprised of an independent group of medical and scientific experts with the responsibility for reviewing and evaluating patient safety and efficacy data from the HEAT study. The interim analysis is intended to evaluate safety, efficacy and futility to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success to continue, modify or terminate the study.
Consistent with the Company’s global regulatory strategy, Celsion is continuing to enroll patients in the HEAT study in order to randomize at least 200 patients in China, a requirement for registrational filing in China. In addition to meeting the FDA enrollment objective, the HEAT study has also enrolled a sufficient number of patients to support, in Asia, registrational filings in S. Korea and Taiwan, two important markets for ThermoDox. Continued enrollment will have no effect on the timing for the pre-planned interim analysis, and has the potential to improve the time to final data.
Date: August 3, 2011
Source: Celsion Corporation
Filed Under: Drug Discovery