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COLUMBIA, MD, United States

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Celsion Corporation | Date: 2016-11-29

The present invention relates to a formulation of thermosensitive liposomes, and more specifically to a formulation of liposomes comprising phospholipids and a surface active agent, wherein the liposomes support long term storage at temperatures less than or equal to about 8 C., control degradate formation to maximize product potency and release their contents at mild hyperthermic temperatures. Methods of making formulations are also described.


News Article | November 15, 2016
Site: www.prnewswire.co.uk

ReportsnReports.com adds "Bladder Cancer - Pipeline Review, H2 2016" to its store, providing comprehensive information on the therapeutics under development for Bladder Cancer, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Bladder Cancer and features dormant and discontinued projects. Bladder cancer occurs in tissues of the urinary bladder. Symptoms include blood or blood clots in the urine, frequent urination, lower back pain on one side of the body and burning during urination. Risk factors for bladder cancer include smoking, exposure to substances such as rubber, certain dyes and textiles, paint, and hairdressing supplies, diet rich in fried meats and fat, old age, sex and color, certain parasitic infections. Treatment of bladder cancer includes chemotherapy, surgery, biological therapy and radiation therapy. Complete report on Global Bladder Cancer Market Research with 151 market data tables and 17 figures, spread across 742 pages is available at http://www.reportsnreports.com/reports/747719-bladder-cancer-pipeline-review-h2-2016.html . Company Analysis and Positioning discussed in this research are 4SC AG, Adaptimmune Therapeutics Plc, ADC Therapeutics SA, Agenus Inc, Altor BioScience Corporation, AndroScience Corporation, APIM Therapeutics AS, Arno Therapeutics, Inc., Astellas Pharma Inc., Astex Pharmaceuticals Inc, Aura Biosciences, Inc., AVEO Pharmaceuticals, Inc., Azaya Therapeutics, Inc., Bavarian Nordic A/S, Bayer AG BioCancell Ltd, Biomics Biotechnologies Co., Ltd., Bioncotech Therapeutics SL, Biotest AG, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, Celgene Corporation, Cellceutix Corporation, Celldex Therapeutics, Inc., Celprogen, Inc., Celsion Corporation, Codagenix, Inc., Cold Genesys, Inc., Corvus Pharmaceuticals Inc, CytomX Therapeutics, Inc., DormaTarg, Inc., Eisai Co., Ltd., Eleven Biotherapeutics Inc., Eli Lilly and Company, Elsalys Biotech SAS, enGene, Inc, Esperance Pharmaceuticals, Inc., Exelixis, Inc., F. Hoffmann-La Roche Ltd., Five Prime Therapeutics, Inc., Gene Signal International SA, Genmab A/S, GlaxoSmithKline Plc, H3 Biomedicine Inc., Hamlet Pharma AB, Heat Biologics, Inc., HEC Pharm Co., Ltd., Hutchison MediPharma Limited, Idera Pharmaceuticals, Inc., ImmuNext, Inc., Immunocore Limited, Immunomedics, Inc., Immupharma Plc, InteRNA Technologies B.V., Johnson & Johnson, LipoMedix Pharmaceutical Inc., MacroGenics, Inc., MaxiVAX SA, Meabco A/S, Medicenna Therapeutics, Inc., MedImmune LLC, Merck & Co., Inc., Merck KGaA, Mirati Therapeutics Inc., Mirna Therapeutics, Inc., Miyarisan Pharmaceutical Company, Ltd, Moleculin Biotech Inc, NanoCarrier Co., Ltd., Nektar Therapeutics, NuCana BioMed Limited, Omeros Corporation, Oncogenex Pharmaceuticals, Inc., Oncolytics Biotech Inc., OncoTherapy Science, Inc., Ono Pharmaceutical Co., Ltd., Optimum Therapeutics, LLC, Pfizer Inc., Pharma Mar, S.A., Philogen S.p.A., Plexxikon Inc., Polaris Pharmaceuticals, Inc., Provectus Biopharmaceuticals, Inc., PsiOxus Therapeutics Limited, Rexahn Pharmaceuticals, Inc., Rodos BioTarget GmbH, Sanofi, Savoy Pharmaceuticals, Inc., Serometrix, LLC, Shionogi & Co., Ltd., Sillajen Biotherapeutics, Sorrento Therapeutics Inc, Spectrum Pharmaceuticals, Inc., Stemline Therapeutics, Inc., Sun Pharma Advanced Research Co Ltd, Synovo GmbH, Taiwan Liposome Company, Ltd., Tara Immuno-Oncology Therapeutics LLC, Taris Biomedical LLC, Telormedix SA, TesoRx Pharma LLC, Theravectys SA, Theryte Limited, Transgene SA, UroGen Pharmaceuticals, Ltd., Vakzine Projekt Management GmbH, Vault Pharma Inc., Vaxeal Holding SA, Vaxiion Therapeutics, Inc. and Viralytics Ltd. The Bladder Cancer (Oncology) pipeline guide also reviews of key players involved in therapeutic development for Bladder Cancer and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Phase III, Phase II, Phase I, IND/CTA Filed, Preclinical and Discovery stages are 1, 9, 44, 35, 2, 56 and 12 respectively. Similarly, the Universities portfolio in Phase II, Phase I, Preclinical and Discovery stages comprises 3, 1, 12 and 2 molecules, respectively. Bladder Cancer (Oncology) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. ReportsnReports.com is your single source for all market research needs. Our database includes 500,000+ market research reports from over 100+ leading global publishers & in-depth market research studies of over 5000 micro markets. With comprehensive information about the publishers and the industries for which they publish market research reports, we help you in your purchase decision by mapping your information needs with our huge collection of reports. Connect With Us on:


News Article | February 15, 2017
Site: globenewswire.com

Dublin, Feb. 15, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Cancer Nanomedicine Market Outlook 2022" report to their offering. The future of cancer nanotechnology lies on a multifunctional nanoplatform that combines both therapeutic components and multimodality imaging. The ultimate goal is that multifunctional nanomedicine works as efficient, targeted in vivo drug delivery without systemic toxicity, and the dose delivered as well as the therapeutic efficacy can be accurately measured noninvasively with time. In the future, nanotechnology could possibly be strategically implemented in new developing drug delivery systems which could lead to significant expansion in the drug markets. These new drug delivery methods are likely to provide the appropriate platform for the pharmaceutical companies to reformulate their existing drugs in the market. This would in turn lead to extending the life of their products and ensuring an improved performance of drugs by increasing effectiveness, safety and patient adherence, and ultimately reducing healthcare costs. Global Cancer Nanomedicine Market Outlook 2022 Report Highlights: - Overview & Mechanism of Action of Nanomedicine - Nanomedicine Engineering: Design & Strategy - Cancer Nanomedicine as Diagnostic & Therapeutics Tool - Global Cancer Nanomedicine Market Overview & Dynamics - Global Cancer Nanomedicine Clinical Pipeline by Company, Indication & Phase - Global Cancer Nanomedicine Clinical Pipeline: 124 Drug - Marketed Cancer Nanomedicine: 8 Drugs Key Topics Covered: 1. Cancer Nanomedicine: An Optimistic Avenue 1.1 Introduction 1.2 Emergence of Nanomedicines 2. Prerequisite of Nanomedicines 2.1 Conventional Cancer Treating Approaches 2.2 Nanomedicines: Overcoming the Hurdles 3. Diversification of Nanomedicines 3.1 Classification on Basis of Constituents 3.1.1 Inorganic Nanoparticles 3.1.2 Organic Nanoparticles 3.2 Classification on Basis of Applicability 3.2.1 Nanomedicine as Diagnostic Agents 3.2.2 Nanomedicine as Therapeutic Agents 3.2.3 Nanomedicine as Drug Delivery Agents 3.3 Classification on Basis of Dimensions 4. Mechanism of Action of Nanomedicine 4.1 Targeting Tumor Cells 4.1.1 Passive Targeting 4.1.2 Active Targeting 4.2 Nanocarrier - Drug Complex 4.2.1 Liposomes 4.2.2 Dendrimers 4.2.3 Micelles 4.2.4 Inorganic Nanocarriers 4.3 Drug Release Systems 5. Nanomedicine Engineering: Design & Strategy 5.1 Organic Nanoparticles as Nanomedicines 5.1.1 Polymeric Nanoparticle 5.1.2 Lipid Organic Nanoparticles 5.2 Inorganic Nanoparticles as Nanomedicines 5.2.1 Synthesis of Gold Nanoparticle 6. Cancer Nanomedicine as Diagnostic Tool 6.1 Detection of Cancer Biomarkers 6.1.1 Detection of Circulating Tumor Cell 6.2 Diagnostic Device & Nanoprobes 6.2.1 Biosensors 6.2.2 Microarrays 6.3 Quantum Dots for Early Cancer Detection 6.3.1 Detection of primary Cancers 6.3.2 Quantum Dots for Tumor Imaging 7. Cancer Therapeutics with Nanomedicines 7.1 Nanomedicine as Therapeutic Agents 7.1.1 Photodynamic Therapy 7.1.2 Photo Thermal Therapy 7.2 Nanomedicines as Prophylactic & Therapeutic Approach 7.2.1 Cancer Cell Destruction 7.3 Nanomedicine in Breast Cancer 7.4 Nanomedicine in Pancreatic Cancer 7.5 Nanomedicine in Brain Cancer 7.6 Nanomedicine in Lung Cancer 8. Cancer Imaging with Nanomedicine 8.1 Positron Emission Tomography 8.1.1 Applications in various Cancers 8.2 Single Photon Emitted Tomography 8.2.1 Computed Tomography 8.3 Magnetic Resonance Imaging (MRI) 8.3.1 Optical Imaging 9. Drug Delivery with Nanomedicines 9.1 Nanocarrier & Chemotherapy 9.1.1 Peptide Nanomedicine- An Example of Nanocarrier Chemotherapy 9.2 Nanomedicine Endocytosis & Intracellular Mechanisms 9.3 Factors Affecting Drug Delivery 10. Global Cancer Nanomedicine Market Overview 10.1 Current Market Scenario 10.2 Global Cancer Nanomedicine Clinical Pipeline Overview 11. Global Nanomedicine Market Dynamics 11.1 Encouraging Market Aspects 11.2 Commercialization Challenges 12. Global Cancer Nanomedicine Future Prospect 13. Global Cancer Nanomedicine Clinical Pipeline by Company, Indication & Phase 13.1 Research 13.2 Preclinical 13.3 Phase-I 13.4 Phase-I/II 13.5 Phase-II 13.6 Phase-III 14. Marketed Cancer Nanomedicine Clinical Insight by Company, Indication & Phase 14.1 Doxorubicin Liposomal (Caelyx & Doxil) 14.2 Albumin-Bound Paclitaxel (Abraxane & Coraxane) 14.3 Nilotinib (Tasigna) 14.4 Paclitaxel Polymeric Micelle Formulation (Cynviloq & Genexol-PM) 14.5 Paclitaxel Liposomal 14.6 Vincristine Liposomal (Marqibo) 14.7 Rexin-G 14.8 Paclitaxel Nanoparticle (Nanoxel) 15. Competitive Landscape 15.1 Abraxis BioScience 15.2 Access Pharmaceuticals 15.3 Alnylam Pharmaceuticals 15.4 Amgen 15.5 Arrowhead Research 15.6 BIND Therapeutics 15.7 Cadila Healthcare 15.8 Celegen Corporation 15.9 Celsion Corporation 15.10 Genzyme Corporation 15.11 Merck 15.12 NanoCarrier 15.13 Nippon Kayaku 15.14 Nanobiotix 15.15 Novavax 15.16 Pfizer 15.17 Roche 15.18 Samyang 15.19 Sanofi 15.20 Takeda Pharmaceutical For more information about this report visit http://www.researchandmarkets.com/research/3th7xh/global_cancer


News Article | February 15, 2017
Site: globenewswire.com

LAWRENCEVILLE, N.J., Feb. 15, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (the “Company”) (NASDAQ:CLSN) today announced the pricing of a public offering with expected total gross proceeds of approximately $5.0 million. The offering was priced at $0.23 per share of common stock (or common stock equivalent), with each share of common stock (or common stock equivalent) sold with one five-year warrant to purchase 0.75 of a share of common stock, at an exercise price of $0.23 per share. The offering is expected to close on or about February 21, 2017, subject to satisfaction of customary closing conditions. Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC, is acting as exclusive lead placement agent and Maxim Group LLC is acting as co-placement agent in connection with this offering. The estimated net proceeds to the Company are expected to be approximately $4.3 million, excluding the proceeds, if any, from the exercise of the warrants.  Celsion intends to use the net proceeds from this offering primarily to continue funding development of OPTIMA, its ongoing Phase III clinical trial of ThermoDox® in patients with primary liver cancer and OVATION, its ongoing Phase I clinical trial of GEN-1 in patients with advanced ovarian cancer and for general corporate purposes, including research and development activities, capital expenditures and working capital. The securities are being offered pursuant to a registration statement on Form S-1 (File No. 333-215321) previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective on February 14, 2017.  The securities may be offered only by means of a prospectus. The preliminary prospectus related to the offering has been filed with the SEC and a final prospectus related to the offering will be filed with the SEC on or about February 15, 2017.  Copies of the preliminary prospectus and the final prospectus, when available, may be obtained at the SEC's website located at http://www.sec.gov, and may also be obtained from H.C. Wainwright & Co., LLC by calling (646) 975-6996 or emailing placements@hcwco.com or Maxim Group LLC by calling (212) 895-3745 or emailing syndicate@maximgrp.com. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Statements made in this press release include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, but not limited to, the amount and use of proceeds the Company expects to receive from the sale of the shares of the securities offered, market conditions, and the closing of the transaction described in this press release, which is subject to customary conditions. Forward-looking statements can be identified by the use of words such as "may," "will," "expect," "anticipate," "estimate," "continue," or comparable terminology. Such forward-looking statements are inherently subject to certain risks, trends and uncertainties, many of which the Company cannot predict with accuracy and some of which the Company might not even anticipate, and involve factors that may cause actual results to differ materially from those projected or suggested. Readers are cautioned not to place undue reliance on these forward-looking statements and are advised to consider the factors listed above together with the additional factors under the heading "Forward-Looking Statements" and "Risk Factors" in the Company's Quarterly Report on Form 10-Q, dated November 10, 2016. The Company assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.


News Article | December 20, 2016
Site: globenewswire.com

LAWRENCEVILLE, N.J., Dec. 20, 2016 (GLOBE NEWSWIRE) -- Celsion Corporation (the “Company”) (NASDAQ:CLSN) today announced that it has entered into a definitive agreement with several institutional investors to purchase an aggregate of approximately $1.8 million of shares of common stock in a registered direct offering. The Company agreed to sell an aggregate of approximately 5.2 million shares of common stock at a price of $0.35 per common share in the registered direct offering. Additionally, the investors will receive, for each share of common stock purchased in the registered direct offering, a warrant to purchase a share of common stock. The warrants have an exercise price of $0.46 per share, are initially exercisable six months following issuance, and terminate five and one-half years following issuance. The closing of this offering is expected to take place on or about December 23, 2016, subject to the satisfaction of customary closing conditions. Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC is acting as exclusive placement agent in connection with this offering. The estimated net proceeds to the Company from the sale of the shares of common stock in the registered direct offering are expected to be approximately $1.6 million. The Company intends to use the net proceeds for general corporate purposes. A shelf registration statement (File No. 333-206789) relating to the shares of common stock to be issued (but not the warrants or the shares of common stock underlying such warrants) was filed with and declared effective by the Securities and Exchange Commission (the “SEC”). A prospectus supplement relating to the offering of shares of common stock to be issued will be filed by the Company with the SEC. Copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at http://www.sec.gov, from request at H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY, 10022 by e-mailing placements@hcwco.com, or from Celsion Corporation, 997 Lenox Drive, Suite 100, Lawrenceville, NJ 08648, Attention: Chief Financial Officer. The warrants and the shares of common stock underlying such warrants to be issued in the offering have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws. Accordingly, the warrants and shares of common stock underlying such warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company in the registered direct offering or the concurrent private placement. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Statements made in this press release include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, but not limited to, the amount and use of proceeds the Company expects to receive from the sale of the shares of common stock in the registered direct offering and the warrants and the closing of the transaction described in this press release, which is subject to customary conditions. Forward-looking statements can be identified by the use of words such as "may," "will," "plan," "should," "expect," "anticipate," "estimate," "continue," or comparable terminology. Such forward-looking statements are inherently subject to certain risks, trends and uncertainties, many of which the Company cannot predict with accuracy and some of which the Company might not even anticipate, and involve factors that may cause actual results to differ materially from those projected or suggested. Readers are cautioned not to place undue reliance on these forward-looking statements and are advised to consider the factors listed above together with the additional factors under the heading "Forward-Looking Statements" and "Risk Factors" in the Company's Annual Reports on Form 10-K, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. The Company assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.


Complete Clinical and Translational Research Data to be Announced During the Second Quarter LAWRENCEVILLE, N.J., Feb. 27, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) today announced that Khursheed Anwer, Ph.D., Celsion’s executive vice president and chief science officer, presented two posters on February 23, 2017 at the American Society of Clinical Oncology (ASCO) - Society for Immunotherapy of Cancer (SITC) Clinical Immuno-Oncology Symposium held from February 23 – 25, 2017 in Orlando, FL.  The ASCO-SITC Clinical Immuno-Oncology Symposium focused on the latest clinical and translational research in immuno-oncology and the implications for clinical care.  The first poster (#155) entitled “Phase I study and activity of formulated IL-12 plasmid administered intraperitoneally in combination with standard neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer” reported the latest clinical results from the Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company's IL-12 gene-mediated immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with Stage III and IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive clinical results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. The second poster (#156) entitled “Immunological changes following intraperitoneal administration of a formulated IL-12 plasmid in combination with standard neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer” reported preliminary translational data from the OVATION Study focusing primarily on the treatment-related changes in immune activating and immune suppressive T-cell populations in tumor tissue and in the levels of relevant cytokines in tumor ascites. “Our hypothesis is that GEN-1 plus neoadjuvant chemotherapy treatment will reprogram the tumor immune microenvironment towards a potent antitumor immune response,” said Dr. Anwer.  “The available data demonstrate highly relevant immunological changes in the tumor immune environment, which supports the immune activating role of GEN-1 in this patient population.   We are currently analyzing the tissue samples for additional immune cell populations and immune cytokines, and look forward to sharing a complete set of the clinical and translational results with the scientific and medical community.” The OVATION Study is designed to enroll three to six patients per dose cohort with the goal of identifying a safe, tolerable and immunologically active dose of GEN-1 by recruiting and maximizing an immune response. Enrollment in the fourth and final cohort is ongoing with the final three patients currently on study.  Celsion expects to complete the enrollment and treatment phase of the OVATION Study early in the second quarter and report final data, including translational data for all patients, by the end of the second quarter of 2017. "We are very encouraged, as have been our Investigators, by the findings to-date in this difficult-to-treat patient population,” said Michael H. Tardugno, Celsion's chairman, president and CEO.  “Over the past year, we have demonstrated the potential of our GEN-1 program, in both first and second-line ovarian cancer, and we look forward to reporting final clinical and translational data from this important study in the second quarter of 2017." The two poster presentations will be available on Celsion’s website under “News & Investors – Scientific Presentations.” Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer and in Phase II development for the treatment of recurrent chest wall breast cancer. The pipeline also includes GEN-1, a gene-mediated immunotherapy for the localized treatment of ovarian and brain cancers. Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anticancer DNA or RNA therapies. For more information on Celsion, visit our website: http://www.celsion.com. (CLSN-G1 CLSN-OV) Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.  Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion's periodic reports and prospectuses filed with the Securities and Exchange Commission.  Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. ¹ Petrillo M, Zannoni GF, Tortorella L, et al. Prognostic role and predictors of complete pathologic response to neoadjuvant chemotherapy in primary unresectable ovarian cancer. American Journal of Obstetrics & Gynecology 2014


Third Cohort of Patients Continues to Show Clinically Meaningful Responses in the Evaluation of GEN-1, A Novel IL-12 DNA-based Immunotherapy, in Combination with the Standard of Care Top Line Translational Data from First Two Cohorts Demonstrates Potential Immune Activation LAWRENCEVILLE, N.J., Nov. 10, 2016 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) today announced data from the third cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company's DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. In the first nine patients dosed, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. “While the patient number in this trial may be small, the consistency and robust nature of the data across all three cohorts and the encouraging clinical responses underscore the potential of GEN-1 to serve as an effective, safe IL-12 immunotherapy in ovarian cancer,” said Nicholas Borys, M.D., Celsion's chief medical officer. “I am particularly impressed with the pathological response data, which is known to be associated with prolonged survival in this patient population. The data generated support continued evaluation of GEN-1 in ovarian cancer, and we look forward to seeing how GEN-1 performs in the fourth and final study cohort.” The OVATION Study is designed to enroll three to six patients per dose cohort with the goal of identifying a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. The first three cohorts each enrolled three patients. Enrollment in the fourth cohort is ongoing, and Celsion expects to complete the OVATION Study this year and report data in early 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin® and Doxil®. OVATION Study – Totality of Results in the First Three Cohorts OVATION Study – Top Line Translational Data from First Two Cohorts Celsion also reported initial translational data from the first two cohorts of the OVATION study. Tumor and blood samples collected before the start of the neoadjuvant chemotherapy (NACT) and after the completion of GEN-1 treatment at debulking surgery are being analyzed for immune cell populations. Top line data demonstrates intriguing immunological changes in the tumor that are consistent with the activation of the immune system. Specifically, Additional immune analysis of biological tissue including cytokine ELISA from the first two patient cohorts and a complete analysis of the two higher dose cohorts is in progress. “The  clinical and translational data generated to date are meaningful and reinforce our confidence in the potential of GEN-1 to address advanced Stage III and IV ovarian cancer, a population clearly in need of effective therapies,” said Dr. Khursheed Anwer, Ph.D., MBA, Celsion's chief scientific officer. “We anticipate completion of enrollment in the fourth patient cohort in the coming weeks, and will continue to assess a potential accelerated clinical development path for GEN-1. In parallel, we are currently evaluating translational data from the study, which we expect to report before the end of the fourth quarter.” Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer and in Phase II development for the treatment of recurrent chest wall breast cancer. The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anticancer DNA or RNA therapies, including TheraPlas™ and TheraSilence™. For more information on Celsion, visit our website: http://www.celsion.com. (CLSN-G1 CLSN-OV) Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion's periodic reports and prospectuses filed with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. ¹ Petrillo M, Zannoni GF, Tortorella L, et al. Prognostic role and predictors of complete pathologic response to neoadjuvant chemotherapy in primary unresectable ovarian cancer. American Journal of Obstetrics & Gynecology 2014


LAWRENCEVILLE, N.J., Nov. 04, 2016 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), a clinical stage oncology drug development company, today announced that the United States Patent and Trademark Office (USPTO) has granted two patents: Patent No. 9,468,687 B2 – Immuno Gene Therapy for Treatment of Cancer and Hyperproliferative Diseases, which expands the use of GEN-1 into additional cancer treatment modalities in combination with other chemotherapeutics and Patent No. 9,144,546 – Nucleic Acid-Lipopolymer Compositions, which expands and extends previous patent claims on the making of and composition of formulations consisting of our PPC delivery polymer and nucleic acids. These new patents further strengthen coverage of GEN-1, the Company’s DNA-based immunotherapy in development for the localized treatment of ovarian cancer and glioblastoma multiforme (GBM), which is already covered by a composition of matter patent in the United States. “Issuance of these patents further strengthens Celsion’s growing position as a leader in the development of gene-based immunotherapies addressing some of the most difficult-to-treat cancers, such as ovarian cancer and GBM by covering the use of GEN-1 for treating solid tumors as a monotherapy and in combination with chemotherapy,” said Michael H. Tardugno, chairman, president and CEO.  “GEN-1 leverages our proprietary TheraPlas™ technology platform, harnessing the power of IL-12 immunotherapy with a targeted delivery system engineered to overcome the limitations associated with the development of other dosage forms of IL-12 therapies.” GEN-1 is being evaluated in an ongoing Phase 1b dose-escalating clinical trial (the “OVATION Study”) combining GEN-1 with the standard of care for the treatment of newly diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debunking surgery.  The OVATION Study is designed to enroll three to six patients per dose cohort at escalating doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an antitumor immune response. As previously reported, all six patients in the first two cohorts of the OVATION Study experienced a clinically meaningful response, ranging from stable disease to one pathologically confirmed complete response.  In addition, all patients sustained decreases of 90% or greater of the prospective indicator of the presence of ovarian cancer cells, CA-125 protein as well as highly impressive pathologically responses, which is associated with prolonged survival. The first three cohorts each enrolled three patients.  Enrollment in the fourth and final cohort is underway, and Celsion expects to report full data from the OVATION Study by the first quarter of 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin® and Doxil® for the treatment of recurrent ovarian cancer. Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer and in Phase II development for the treatment of recurrent chest wall breast cancer.  The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers.  Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies, including TheraPlas™ and TheraSilence™.  For more information on Celsion, visit our website: http://www.celsion.com (CLSN-FIN). Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.  Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion's periodic reports and prospectuses filed with the Securities and Exchange Commission.  Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

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