COLUMBIA, MD, United States
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.


LAWRENCEVILLE, N.J., May 05, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) announced today that the Company will host a conference call to discuss financial results for the quarter ended March 31, 2017 and provide an update on its development programs for ThermoDox®, its proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA plasmid vector formulated into a nanoparticle with a non-viral delivery system at 11:00 a.m. EDT on Friday, May 12, 2017. To participate in the call, interested parties may dial 1-888-282-4591 (Toll-Free/North America) or 1-719-457-2605 (International/Toll) and ask for the Celsion Corporation 1st Quarter 2017 Earnings Call (Conference Code: 4060768) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live over the internet at www.celsion.com. The call will be archived for replay on Friday, May 12, 2017 and will remain available until Friday, May 26, 2017. The replay can be accessed at 1-888-203-1112 (Toll-Free/North America) or 1-719-457-0820 (International/Toll) using Conference Code: 4060768.  An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT on Friday, May 12, 2017. 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. For more information on Celsion, visit our website: http://www.celsion.com. (CLSN-FIN).


LAWRENCEVILLE, N.J., May 04, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) today announced updated additional clinical and translational research data from its 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 (NACT) followed by interval debulking surgery.  Of the five evaluable patients in the first two cohorts who have been on the study for over one year, only one patient’s cancer has progressed after 11.7 months.  This compares quite favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer who undergo neoadjuvant chemotherapy (NACT) followed by interval debulking surgery.  Of the remaining four patients in the first two cohorts, their average PFS is 15.1 months with the longest progression-free patient at 19.1 months.  None of the patients in the third or fourth dosing cohorts have progressed to date. “This new data on progression-free survival adds to the impressive clinical findings seen across a number of meaningful measures used to assess ovarian cancer like a 75% objective tumor response rate and a greater than 50% R0 (margin-negative) surgical resection rate,” said Dr. Nicholas Borys, M.D., Celsion's chief medical officer. “The consistency and robust nature of the data across all four cohorts and the encouraging clinical responses underscore the potential of GEN-1 to serve as an effective, safe IL-12 immunotherapy in ovarian cancer.” The Company also reported preliminary translational research findings from the first four patient cohorts. The analysis of peritoneal fluid and blood samples collected immediately before and 24 hours after IP administration of multiple doses of GEN-1 (36, 47, 61, 72 mg/m2) and standard NACT (carboplatin every 21 days and Taxol weekly) shows clear evidence of IL-12 gene transfer by significant dose dependent increases in IL-12 levels and immune system activity and significant increases in IFN-gamma and decreases in VEGF levels.  The treatment-related changes in immune activating cytokines and pro-tumor VEGF levels followed a dose-dependent trend and were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic blood stream. The immuno-histochemical (IHC) analysis of tumor tissue collected before treatment (laparoscopy) and after completion of eight GEN-1 weekly treatments showed increased infiltration of CD3+, CD4+ CD8+ T-cells into tumor tissue of several patients. The most pronounced effects observed in the IHC analysis were decreases in the density of immunosuppressive T-cell signals (FoxP3, PD-1, PDL-1, IDO-1) in the tumor microenvironment. The ratio of CD8+ cells to immunosuppressive cells was increased in 60-80% of patients suggesting an overall shift in the immune environment to pro-immune stimulatory following treatment with GEN-1. “These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and creates an immuno-stimulatory cytokine milieu in the peritoneal cavity in a dose-dependent manner and promotes a pro-immune T-cell population dynamics in the tumor micro-environment,” said Dr. Khursheed Anwer, Celsion’s executive vice president and chief science officer.  “These distinct immunological changes in local disease environment appear to translate into clinical benefit and warrant the continued development of our GEN-1 IL-12 immunotherapy as a potential adjuvant, in both first and second-line 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 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, 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.


LAWRENCEVILLE, N.J., May 04, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) today announced updated additional clinical and translational research data from its 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 (NACT) followed by interval debulking surgery.  Of the five evaluable patients in the first two cohorts who have been on the study for over one year, only one patient’s cancer has progressed after 11.7 months.  This compares quite favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer who undergo neoadjuvant chemotherapy (NACT) followed by interval debulking surgery.  Of the remaining four patients in the first two cohorts, their average PFS is 15.1 months with the longest progression-free patient at 19.1 months.  None of the patients in the third or fourth dosing cohorts have progressed to date. “This new data on progression-free survival adds to the impressive clinical findings seen across a number of meaningful measures used to assess ovarian cancer like a 75% objective tumor response rate and a greater than 50% R0 (margin-negative) surgical resection rate,” said Dr. Nicholas Borys, M.D., Celsion's chief medical officer. “The consistency and robust nature of the data across all four cohorts and the encouraging clinical responses underscore the potential of GEN-1 to serve as an effective, safe IL-12 immunotherapy in ovarian cancer.” The Company also reported preliminary translational research findings from the first four patient cohorts. The analysis of peritoneal fluid and blood samples collected immediately before and 24 hours after IP administration of multiple doses of GEN-1 (36, 47, 61, 72 mg/m2) and standard NACT (carboplatin every 21 days and Taxol weekly) shows clear evidence of IL-12 gene transfer by significant dose dependent increases in IL-12 levels and immune system activity and significant increases in IFN-gamma and decreases in VEGF levels.  The treatment-related changes in immune activating cytokines and pro-tumor VEGF levels followed a dose-dependent trend and were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic blood stream. The immuno-histochemical (IHC) analysis of tumor tissue collected before treatment (laparoscopy) and after completion of eight GEN-1 weekly treatments showed increased infiltration of CD3+, CD4+ CD8+ T-cells into tumor tissue of several patients. The most pronounced effects observed in the IHC analysis were decreases in the density of immunosuppressive T-cell signals (FoxP3, PD-1, PDL-1, IDO-1) in the tumor microenvironment. The ratio of CD8+ cells to immunosuppressive cells was increased in 60-80% of patients suggesting an overall shift in the immune environment to pro-immune stimulatory following treatment with GEN-1. “These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and creates an immuno-stimulatory cytokine milieu in the peritoneal cavity in a dose-dependent manner and promotes a pro-immune T-cell population dynamics in the tumor micro-environment,” said Dr. Khursheed Anwer, Celsion’s executive vice president and chief science officer.  “These distinct immunological changes in local disease environment appear to translate into clinical benefit and warrant the continued development of our GEN-1 IL-12 immunotherapy as a potential adjuvant, in both first and second-line 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 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, 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.


LAWRENCEVILLE, N.J., May 04, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) today announced updated additional clinical and translational research data from its 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 (NACT) followed by interval debulking surgery.  Of the five evaluable patients in the first two cohorts who have been on the study for over one year, only one patient’s cancer has progressed after 11.7 months.  This compares quite favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer who undergo neoadjuvant chemotherapy (NACT) followed by interval debulking surgery.  Of the remaining four patients in the first two cohorts, their average PFS is 15.1 months with the longest progression-free patient at 19.1 months.  None of the patients in the third or fourth dosing cohorts have progressed to date. “This new data on progression-free survival adds to the impressive clinical findings seen across a number of meaningful measures used to assess ovarian cancer like a 75% objective tumor response rate and a greater than 50% R0 (margin-negative) surgical resection rate,” said Dr. Nicholas Borys, M.D., Celsion's chief medical officer. “The consistency and robust nature of the data across all four cohorts and the encouraging clinical responses underscore the potential of GEN-1 to serve as an effective, safe IL-12 immunotherapy in ovarian cancer.” The Company also reported preliminary translational research findings from the first four patient cohorts. The analysis of peritoneal fluid and blood samples collected immediately before and 24 hours after IP administration of multiple doses of GEN-1 (36, 47, 61, 72 mg/m2) and standard NACT (carboplatin every 21 days and Taxol weekly) shows clear evidence of IL-12 gene transfer by significant dose dependent increases in IL-12 levels and immune system activity and significant increases in IFN-gamma and decreases in VEGF levels.  The treatment-related changes in immune activating cytokines and pro-tumor VEGF levels followed a dose-dependent trend and were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic blood stream. The immuno-histochemical (IHC) analysis of tumor tissue collected before treatment (laparoscopy) and after completion of eight GEN-1 weekly treatments showed increased infiltration of CD3+, CD4+ CD8+ T-cells into tumor tissue of several patients. The most pronounced effects observed in the IHC analysis were decreases in the density of immunosuppressive T-cell signals (FoxP3, PD-1, PDL-1, IDO-1) in the tumor microenvironment. The ratio of CD8+ cells to immunosuppressive cells was increased in 60-80% of patients suggesting an overall shift in the immune environment to pro-immune stimulatory following treatment with GEN-1. “These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and creates an immuno-stimulatory cytokine milieu in the peritoneal cavity in a dose-dependent manner and promotes a pro-immune T-cell population dynamics in the tumor micro-environment,” said Dr. Khursheed Anwer, Celsion’s executive vice president and chief science officer.  “These distinct immunological changes in local disease environment appear to translate into clinical benefit and warrant the continued development of our GEN-1 IL-12 immunotherapy as a potential adjuvant, in both first and second-line 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 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, 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.


LAWRENCEVILLE, N.J., May 04, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) today announced updated additional clinical and translational research data from its 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 (NACT) followed by interval debulking surgery.  Of the five evaluable patients in the first two cohorts who have been on the study for over one year, only one patient’s cancer has progressed after 11.7 months.  This compares quite favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer who undergo neoadjuvant chemotherapy (NACT) followed by interval debulking surgery.  Of the remaining four patients in the first two cohorts, their average PFS is 15.1 months with the longest progression-free patient at 19.1 months.  None of the patients in the third or fourth dosing cohorts have progressed to date. “This new data on progression-free survival adds to the impressive clinical findings seen across a number of meaningful measures used to assess ovarian cancer like a 75% objective tumor response rate and a greater than 50% R0 (margin-negative) surgical resection rate,” said Dr. Nicholas Borys, M.D., Celsion's chief medical officer. “The consistency and robust nature of the data across all four cohorts and the encouraging clinical responses underscore the potential of GEN-1 to serve as an effective, safe IL-12 immunotherapy in ovarian cancer.” The Company also reported preliminary translational research findings from the first four patient cohorts. The analysis of peritoneal fluid and blood samples collected immediately before and 24 hours after IP administration of multiple doses of GEN-1 (36, 47, 61, 72 mg/m2) and standard NACT (carboplatin every 21 days and Taxol weekly) shows clear evidence of IL-12 gene transfer by significant dose dependent increases in IL-12 levels and immune system activity and significant increases in IFN-gamma and decreases in VEGF levels.  The treatment-related changes in immune activating cytokines and pro-tumor VEGF levels followed a dose-dependent trend and were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic blood stream. The immuno-histochemical (IHC) analysis of tumor tissue collected before treatment (laparoscopy) and after completion of eight GEN-1 weekly treatments showed increased infiltration of CD3+, CD4+ CD8+ T-cells into tumor tissue of several patients. The most pronounced effects observed in the IHC analysis were decreases in the density of immunosuppressive T-cell signals (FoxP3, PD-1, PDL-1, IDO-1) in the tumor microenvironment. The ratio of CD8+ cells to immunosuppressive cells was increased in 60-80% of patients suggesting an overall shift in the immune environment to pro-immune stimulatory following treatment with GEN-1. “These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and creates an immuno-stimulatory cytokine milieu in the peritoneal cavity in a dose-dependent manner and promotes a pro-immune T-cell population dynamics in the tumor micro-environment,” said Dr. Khursheed Anwer, Celsion’s executive vice president and chief science officer.  “These distinct immunological changes in local disease environment appear to translate into clinical benefit and warrant the continued development of our GEN-1 IL-12 immunotherapy as a potential adjuvant, in both first and second-line 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 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, 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.


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 | 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


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


Patent
Celsion Corporation | Date: 2013-02-15

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.

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