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Last $2.82 USD
Change Today -0.05 / -1.74%
Volume 77.4K
CLSN On Other Exchanges
As of 5:20 PM 03/6/15 All times are local (Market data is delayed by at least 15 minutes).

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celsion corp (CLSN) Details

Celsion Corporation, an oncology drug development company, focuses on the development and commercialization of chemotherapeutic oncology drugs based on its proprietary heat-activated liposomal technology. The company’s lead product includes ThermoDox, a liposomal encapsulation of doxorubicin that is in Phase III clinical trials for primary liver cancer; under Phase II clinical trials for recurrent chest wall breast cancer; and in phase II clinical trials for colorectal liver metastasis. It has a development, product supply, and commercialization agreement with Yakult Honsha Co. Ltd. for ThermoDox; and a commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. for the production of ThermoDox in mainland China, Hong Kong, and Macau. The company was founded in 1982 and is based in Lawrenceville, New Jersey.

13 Employees
Last Reported Date: 03/13/14
Founded in 1982

celsion corp (CLSN) Top Compensated Officers

Chairman, Chief Executive Officer and Preside...
Total Annual Compensation: $434.1K
Chief Financial Officer, Senior Vice Presiden...
Total Annual Compensation: $275.2K
Chief Medical Officer and Senior Vice Preside...
Total Annual Compensation: $328.5K
Compensation as of Fiscal Year 2013.

celsion corp (CLSN) Key Developments

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

Celsion Corporation announced 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, also known as hepatocellular carcinoma. As of January 15, 2015, the latest quarterly overall survival analysis demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the study patients), the combination of ThermoDox and optimized RFA provided a 59% improvement in OS compared to optimized RFA alone. The Hazard Ratio at this analysis is 0.628 (95% CI 0.420 – 0.939) with a p-value of 0.02. The consistency of the data from the HEAT Study over the past two years is quite compelling, demonstrating the significant potential for ThermoDox in combination with an optimized RFA regimen to markedly improve overall survival in primary liver cancer patients. These findings provide a strong rationale for the ongoing OPTIMA Study and may also underscore the interest of clinical investigators to evaluate the potential of ThermoDox plus optimized RFA for curative intent among intermediate stage HCC patients. The data from the most recent quarterly 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 optimized 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. The Phase III OPTIMA Study is expected to enroll up to 550 patients globally in up to 100 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. The primary endpoint for the trial is overall survival, which is supported by post-hoc analysis of data from the Company's 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee.

Celsion Corporation Presents Clinical and Preclinical Data for GEN-1 IL-12 Immunotherapy in Ovarian Cancer at the Molecular Medicine TRI-Conference

Celsion Corporation presented clinical and preclinical data demonstrating the safety, biological activity and clinical benefits of GEN-1, its DNA-based immunotherapy, as a single agent in advanced platinum-resistant and recurrent ovarian cancer patients, at the Molecular Medicine TRI-Conference in San Francisco. These data provide support for advancing GEN-1 into clinical development in the front-line setting. The Company also announced that the U.S. Food and Drug Administration (FDA) has accepted, without comment, its planned Phase 1 dose-escalation clinical trial of GEN-1 in combination with the standard of care in neo-adjuvant ovarian cancer, which is expected to commence in mid-2015 at five to six U.S. clinical centers. These important findings significantly strengthen its established clinical and preclinical data providing additional evidence of GEN-1's ability to effectively recruit a cellular immune system response, widely known for its anti-cancer activity. Evidence now in platinum-resistant and recurrent ovarian cancer patients, populations which historically have had little to no response to new investigational therapies, is highly encouraging. The presentation included data from the recently completed Phase 1b dose-escalation combination study of GEN-1, as well as a review of previously reported data. The Phase 1b study enrolled 16 patients with platinum-resistant ovarian cancer and evaluated the safety, tolerability and efficacy of GEN-1 in combination with pegylated doxorubicin. Patients received pegylated liposomal doxorubicin on day 1 and GEN-1 intra-peritoneally (IP) over days 1, 8, 15 and 22. This treatment course was repeated every 28 days in the absence of disease progression or unacceptable toxicity. The findings demonstrated that there were no overlapping toxicities between GEN-1 and pegylated doxorubicin. Biological activity and clinical efficacy results from this Phase 1b study including disease control rates, translational data and survival rates among the three doses evaluated have been submitted for presentation at the American Society of Clinical Oncologist (ASCO) Conference in the second quarter of 2015 and will be publicly available following ASCO's normal publication schedule. Patients will be followed quarterly for up to one year following completion of study treatment. The data from the Phase 1b study was consistent with previously reported data from two single-agent studies of GEN-1 in platinum-resistant recurrent ovarian cancer. In an earlier Phase 1 study, treatment with GEN-1 demonstrated a DCR of 31%, biological activity and median overall survival (OS) of 18 months. In the Phase 2 study, treatment with GEN-1 demonstrated a DCR of 45% and a median OS of 10 months. In both studies, GEN-1 was well tolerated and no maximum tolerated dose (MTD) was achieved. The data presented highlights the potential value and promise of its IL-12 immunotherapy program and its expectations for the TheraPlas ¢ platform generally. The combination trial is designed to enroll three to six patients per dose level until a safe, tolerable and potentially therapeutically active dose is identified. The study will evaluate safety and efficacy and attempt to define an optimal dose to carry forward into a Phase 2 trial. A copy of the presentation can be found on the Company's website under Events & Presentations.

Celsion Corporation Submits DNA-Based Immunotherapy Clinical Protocol to the FDA as Part of First Line Treatment for Ovarian Cancer

Celsion Corporation announced the submission of its Phase I clinical trial protocol to the U.S. Food and Drug Administration for GEN-1, the company's DNA-based immunotherapy for the localized treatment of cancer. The protocol, developed with guidance from the company's Medical Advisory Board, is designed to establish a safe dose and biological activity of GEN-1 in newly diagnosed ovarian cancer patients who will be undergoing neoadjuvant chemotherapy. GEN-1 has demonstrated encouraging safety and efficacy data in a previous Phase I monotherapy trial in patients with peritoneally metastasized ovarian cancer, and is currently being evaluated in a Phase Ib trial in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer. The clinical study will identify a safe and tolerable dose of GEN-1 while maximizing an immune response. The protocol intends to enroll 3 to 6 patients per dose level until a safe, tolerable and potentially therapeutically active dose is identified. The protocol has been submitted to the FDA for its 30 day review and comment period. Pending this review, the Company expects to initiate enrollment in the second half of 2015.


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