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May 21, 2014
08:03 EDTCLSNCelsion announces regulatory cleraance to initiate Phase III study of Thermodox
Celsion announced it has received regulatory clearance to initiate its Phase III OPTIMA Study at clinical trial sites in Taiwan, Hong Kong, South Korea and Canada. The OPTIMA Study is the company's planned global pivotal, double-blind, placebo-controlled study evaluating ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation, in primary liver cancer, also known as hepatocellular carcinoma. In addition, the company continues to advance its global regulatory strategy and has filed Clinical Trial Applications in the Philippines and Thailand, as well as a request for a Voluntary Harmonization Procedure in Europe, which provides for the assessment of multinational clinical trial applications across several European countries, including Germany, France and Spain. As previously reported, the company has submitted an Application for Accelerated Trial Approval to the China Food and Drug Administration. The Company also plans to expand its clinical site footprint in Europe and will meet with the European Medicines Agency during 2014 to discuss ThermoDox trial design and registrational strategy.
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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