MT: "Celsion stands focused on ThermoDox®'s transformative potential for the largest unmet need remaining in oncology. With positive results from the HEAT Study, we are preparing to introduce the first and most important 1st line drug therapy ever for non-resectable HCC. If successful, we will create substantial value for all of our stakeholders, including the global oncology community, our investors and most importantly HCC patients and their families," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Preparedness leading up to this event is paramount. We have worked to ensure that the HEAT Study is robust and well conducted. We have maintained constant communication with our study sites, our manufacturers and with regulators to ensure a clean, consistent and high quality data package for review in markets around the world. Further, we enter this period with a strong balance sheet, including financial resources that will take us well beyond data and into multiple indications where the promise of ThermoDox® will significantly improve treatment outcomes."
Mr. Tardugno added, "The momentum behind ThermoDox® and our technology platform is evident in the growing interest within industry and the medical and academic communities to explore their application in a broad range of cancers and indications. Following the outcome of the HEAT Study, we intend to accelerate our on-going development programs, an effect that will ultimately reveal the significant potential and elegance of our targeted tumor technology."
Recent Business Developments
In August 2012, the Company and Royal Philips Electronics (Philips) announced FDA clearance to commence a Phase II Study of ThermoDox® and Philip's Sonalleve MR-Guided HIFU technology for the palliation of painful metastases to the bone caused by lung, prostate or breast cancers.