Leading oncology drug development company Celsion Corporation has announced that the independent Data Monitoring Committee (DMC) for its HEAT Study has completed a regularly scheduled review of the 701 patients enrolled in the trial and unanimously recommends that the HEAT Study continue according to protocol to its final data readout. The HEAT Study, being conducted under a Special Protocol Assessment (SPA) agreed to with the FDA, is a fully enrolled, multinational, double-blind, placebo-controlled Phase III trial of ThermoDox in combination with radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC or primary liver cancer).
Progression-free survival (PFS), the HEAT Study’s primary endpoint, is defined in the SPA. In total, 380 PFS events are required for reaching the unblinding and planned final analysis of the study. The company reaffirmed that 380 PFS events are projected to occur during the fourth quarter of 2012, with topline results to be announced after DMC review and confirmation.
Study data has been reviewed by the DMC at regular intervals, with the chief responsibilities of ensuring enrolled patient safety, collected data quality, and continued scientific validity of the study design. As part of its review of the 701 enrolled patients, the DMC monitored a quality matrix relating to the total clinical data set – confirming timely data collection and that all data are current, as well other data collection and quality criteria.
The HEAT Study is the single largest study that has ever been conducted in intermediate-stage primary liver cancer, which is currently the largest unaddressed cancer in oncology. Celsion has the regulatory, manufacturing, financial, and commercial plans and resources in place to ensure success once the HEAT Study’s outcome has been determined. Going forward, the company is confident in ThermoDox’s potential to offer a new and essential therapeutic option for patients suffering with this form of cancer.
In addition to being conducted under an FDA Special Protocol Assessment, the HEAT Study has also received FDA Fast Track designation and has been designated a “Priority Trial” for liver cancer by the National Institutes of Health. ThermoDox has received orphan drug designation in the United States and Europe, and the European Medicines Agency (EMA) has confirmed that the HEAT Study provides an acceptable basis for submission of a marketing authorization application for centralized review and approval. In addition to meeting the enrollment objectives of the FDA and EMA, the HEAT Study has also enrolled a sufficient number of patients to support registration filings in China, South Korea and Taiwan – three additional large and significant markets for ThermoDox.
Celsion, a leading oncology company, is committed to developing and commercializing innovative cancer drugs, including tumor-targeting treatments, using focused heat energy combined with heat-activated liposomal drug technology. The company has research, license, or commercialization agreements with leading institutions that include the National Institutes of Health, Duke University Medical Center, University of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the Kyungpook National University Hospital, the Beijing Cancer Hospital, and the University of Oxford.
For more information, visit the company’s Web site at www.celsion.com
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