Celsion Announces Enrollment of First Patient in Global Phase III OPTIMA Study of ThermoDox® in Primary Liver Cancer

Editor’s note: This article is about a new clinical trial—a research study with volunteer patients. The goal of the trial is to test the effectiveness of a new liver cancer treatment. The treatment combines the drug ThermoDox with a procedure called radiofrequency ablation (AFA). It is meant for people with hepatocellular carcinoma (HCC). The trial has enrolled its first participating patient, and will enroll a total of 550 patients at sites in North America, Europe, China, and Asia Pacific.

“Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced that the first patient has been enrolled in its pivotal Phase III OPTIMA Study of ThermoDox® in combination with optimized radiofrequency ablation (RFA) in patients with primary liver cancer, also known as hepatocellular carcinoma (HCC).  ThermoDox® is Celsion’s proprietary, heat-activated, liposomal encapsulation of doxorubicin.

” ‘There is an urgent need for new treatment options that address primary liver cancer, a rapidly progressing disease with a poor prognosis whose worldwide incidence is growing at an alarming rate,’ stated Won-Young Tak, M.D., Ph.D. at the Kyungpook National University Hospital in South Korea and Asia Pacific Principal Investigator for the OPTIMA Study. ‘The OPTIMA Study builds on extensive clinical and preclinical data that point to the potential of ThermoDox®, when combined with an optimized RFA regimen, to significantly improve patient outcomes. I look forward to working with my colleagues to further explore the clinical utility of ThermoDox® in this setting.’ “


Celsion Announces Updated Overall Survival Data from HEAT Study of ThermoDox® in Primary Liver Cancer

Editor’s note: Researchers conducted a clinical trial with volunteer patients to test the effectiveness of a liver cancer treatment called ThermoDox. Specifically, the trial looked at ThermoDox when given to hepatocellular carcinoma (HCC) patients in combination with radiofrequency ablation (RFA). The researchers found that patients who were treated with the combination survived longer than patients who were treated with RFA alone. 

” ‘As the data from the HEAT Study matures, it increasingly underscores the significant potential of ThermoDox® plus optimized RFA to markedly improve Overall Survival in primary liver cancer patients,’ stated Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of the Diagnostic Imaging and Intervention at the Pisa University School of Medicine in Italy.  ‘There is a pressing need for new treatment options to address HCC, which is a highly prevalent and deadly cancer. The consistency and strength of the HEAT Study data over each of the last five quarterly data analyses provide a strong rationale and clear roadmap for further development of ThermoDox® in this indication.’

“As of June 30, 2014, data from the latest HEAT Study post-hoc analysis continued to strongly suggest that ThermoDox® may significantly improve OS compared to a RFA control in patients whose lesions undergo RFA treatment for 45 minutes or more.  These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients.  For this group, clinical results indicate a 57% improvement in OS, a Hazard Ratio of 0.639 (95% CI 0.419 – 0.974), and a p-value of 0.037.

” ‘The post-hoc HEAT Study data is striking in that it has consistently shown a marked OS benefit for ThermoDox® plus optimized RFA versus RFA alone in each of the quarterly data sweeps, with this 5th, and final data set demonstrating that this survival benefit is statistically significant,’ stated Michael Tardugno, Celsion’s President and Chief Executive Officer. ‘This impressive clinical data set, together with prospective supportive preclinical study results and multivariate Cox Regression Analyses, reinforces our confidence in the protocol for our Phase III OPTIMA Study in primary liver cancer, which is evaluating ThermoDox® in combination with a standardized RFA protocol in primary liver cancer.’ “


Local Tumor Removal Followed by TKI Treatment May Be Effective in Lung Cancer Patients Resistant to TKIs

Many non-small cell lung cancer (NSCLC) patients who receive EGFR-tyrosine kinase inhibitors (TKIs) like erlotinib (Tarceva) and gefitinib (Iressa) develop drug resistance. Some of these patients may also have a small number of metastases (oligometastatic disease), which can be destroyed with local therapy. Local therapy methods include surgical removal, radiation, or electrical current produced by high-frequency radio waves (radiofrequency ablation). A recent study explored the use of local therapy, followed by renewed treatment with EGFR-TKIs, in patients with oligometastatic NSCLC who had become resistant to EGFR-TKIs. The treatment was well tolerated and effective, especially for patients in whom local therapy had removed all known tumors.

Research paper: http://journals.lww.com/jto/Abstract/2013/03000/Local_Therapy_with_Continued_EGFR_Tyrosine_Kinase.14.aspx