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Celsion

$1.66

-0.025 (-1.49%)

08:28
08/13/19
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08:28

Celsion announces publication of results of NIH analysis of ThermoDox

Celsion Corporation announced that results from an independent analysis of the Company's ThermoDox HEAT Study conducted by the National Institutes of Health were published in the peer-reviewed publication, Journal of Vascular and Interventional Radiology. ThermoDox is Celsion's heat-activated liposomal formulation of doxorubicin currently in Phase III development for the treatment of primary liver cancer, also known as hepatocellular carcinoma. The analysis was conducted by the intramural research program of the NIH and the NIH Center for Interventional Oncology, with the full data set from the Company's HEAT Study. The analysis evaluated the full data set to determine if there was a correlation between baseline tumor volume and radiofrequency ablation heating time, with or without ThermoDox treatment, for patients with HCC. The NIH analysis was conducted under the direction of Dr. Bradford Wood, MD, Director, NIH Center for Interventional Oncology and Chief, NIH Clinical Center Interventional Radiology. The article titled, "RFA Duration Per Tumor Volume May Correlate With Overall Survival in Solitary Hepatocellular Carcinoma Patients Treated With RFA Plus Lyso-thermosensitive Liposomal Doxorubicin," discussed the NIH analysis of results from 437 patients in the HEAT Study. The key finding was that increased RFA heating time per tumor volume significantly improved overall survival in patients with single-lesion HCC who were treated with RFA plus ThermoDox, compared to patients treated with RFA alone. A one-unit increase in RFA duration per tumor volume was shown to result in about a 20% improvement in OS for patients administered ThermoDox(R), compared to RFA alone. The authors conclude that increasing RFA heating time in combination with ThermoDox(R) significantly improves OS and establishes an improvement of over two years versus the control arm when the heating time per milliliter of tumor is greater than 2.5 minutes. This finding is consistent with the Company's own results, which defined the optimized RFA procedure as a 45-minute treatment for tumors with a diameter of 3 centimeters. Thus, the NIH analysis lends support to the hypothesis underpinning the OPTIMA Study, Celsion's fully enrolled, on-going Phase III trial in newly diagnosed HCC patients. On August 5, 2019, the Company announced the prescribed number of events has been reached for the first pre-planned interim analysis of the OPTIMA Phase III Study with ThermoDox plus RFA in patients with HCC. Following preparation of the data, the first interim analysis will be conducted by the Independent Data Monitoring Committee. This timeline is consistent with the Company's stated expectations and is necessary to provide a full and comprehensive data set that may represent the potential for a successful trial outcome. Celsion expects to announce iDMC recommendations as soon as possible after their meeting in October. In accordance with the statistical plan, this initial interim analysis has a target of 118 events, or 60% of the total number required for the final analysis. At the time of the data cutoff, the Company received reports of 128 events. The hazard ratio for success at 128 events is approximately 0.637, which represents an approximate 36.3% reduction in the risk of death, consistent with the 0.65 hazard ratio that was observed in the prospective HEAT Study subgroup, which demonstrated a 2-year overall survival advantage and a median time to death of more than 7 1/2 years.

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