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News Breaks
February 24, 2014
08:07 EDTCLSNCelsion announces FDA clearance of the OPTIMA study
Celsion announced that the FDA has reviewed and provided clearance for the company's planned pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radio frequency ablation in primary liver cancer, also known as hepatocellular carcinoma. The trial design is based on a comprehensive analysis of data from the Company's Phase III HEAT Study, which demonstrated that treatment with ThermoDox resulted in a 55% improvement in overall survival in a substantial number of HCC patients that received an optimized RFA treatment. Celsion expects to launch the study in the first half of 2014.
News For CLSN From The Last 14 Days
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May 21, 2015
08:10 EDTCLSNCelsion's TheraSilence RNA program shows positive preclinical data
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May 15, 2015
08:03 EDTCLSNCelsion announces preclinical data confirming delivery of RNA to lung cells
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May 13, 2015
17:11 EDTCLSNCelsion announces ASCO 2015 GEN-1 Immunotherapy Phase 1b results
Celsion Corporation announced that results from its Phase Ib trial for GEN-1 in platinum-resistant ovarian cancer will be presented in poster session at the 2015 American Society of Clinical Oncology meeting in Chicago on Saturday, May 30th. GEN-1 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. Dr. Premal H. Thaker, M.D., associate professor at Washington University and Siteman Cancer Center in St. Louis and a principal investigator for the study, highlighted the results in an abstract titled, "A Phase I Study of Intraperitoneal EGEN-001 in Patients with Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer." The abstract is available on the ASCO website. The Phase 1b dose escalating study enrolled 16 patients with platinum-resistant ovarian cancer and evaluated the safety, tolerability and efficacy of GEN-1 in combination with pegylated doxorubicin as well as the effect of intraperitoneal injection of GEN-1 on IL-12 and tumor cytokine levels. Patients received pegylated liposomal doxorubicin on day 1 and GEN-1 on days 1, 8, 15 and 22. This treatment regimen was repeated every 28 days in the absence of disease progression or unacceptable toxicity. The findings demonstrated an overall clinical benefit of 57% for all treatment arms, with a partial response rate of 21% and a stable disease rate of 36%. The overall clinical benefit observed at the highest dose level was 86%. GEN-1 was well tolerated, with no dose limiting toxicities and no overlapping toxicities between GEN-1, its subsequent immune system activation and pegylated doxorubicin.
May 12, 2015
08:04 EDTCLSNCelsion reports Q1 EPS (35c), consensus (33c)
Reports Q1 revenue $125K, consensus $125K

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