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July 28, 2014
08:08 EDTCLSNCelsion's ThermoDox for liver cancer shows positive overall survival data
Celsion updated results from its retrospective analysis of the company's 701-patient HEAT Study of ThermoDox, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation in primary liver cancer. As of June 30, the latest quarterly Overall Survival analysis demonstrated that in 41% of the study patients, the combination of ThermoDox and optimized RFA provided a 57% improvement in OS compared to optimized RFA alone. 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.
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February 12, 2016
08:03 EDTCLSNCelsion reports FY15-end cash position of $20.1M
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08:02 EDTCLSNCelsion highlights recent pipeline developments for GEN-1 program
Celsion highlighted recent accomplishments related to the Company's GEN-1 immunotherapy pipeline and provided a general business update. Celsion also announced the completion of enrollment of the first cohort of patients in its Phase 1b dose escalating clinical trial combining GEN-1, the Company's DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed ovarian cancer patients who will undergo neoadjuvant chemotherapy followed by surgical resection of their tumor. The first two patients in the OVATION Study who completed treatment have shown promising results. Both patients reported stable disease with a dramatic drop in their CA-125 protein levels of 89% and 98%. Cancer antigen 125 is used to monitor certain cancers during and after treatment. A 50% reduction in CA-125 levels is considered meaningful. Both patients' CA-125 levels were below the normal healthy level of 35 U/mL. In addition, both patients experienced successful surgical resections of their tumors with one patient reporting a R0 resection which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. The OVATION Study will continue into 2016 at higher doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. Celsion has initiated four clinical sites at the University of Alabama at Birmingham; Oklahoma University Medical Center; Washington University in St. Louis and the Medical College of Wisconsin. The trial is designed to enroll three to six patients per dose cohort and will evaluate safety and efficacy and attempt to define an optimal dose for a follow-on Phase I/II study combining GEN-1 with Avastin and Doxil. The company has completed various preclinical studies combining GEN-1 with Avastin and Doxil, the current standard of care for the treatment of platinum resistant ovarian cancer, which has demonstrated synergistic anti-cancer effects.

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