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LAWRENCEVILLE, N.J., May 12, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced financial results for the quarter ended March 31, 2017 and provided 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 encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein.  The Company's lead program is ThermoDox® which is 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 Company's immunotherapy program consists of GEN-1 and is currently in Phase I development for the localized treatment of ovarian cancer. "Celsion continues to make major progress with respect to our ongoing global, pivotal Phase III OPTIMA Study in primary liver cancer.  This ground-breaking study continues to attract interest and support from the medical community, international regulatory agencies, and research organizations like the National Institutes of Health," said Michael H. Tardugno, Celsion's chairman, president and CEO.  "Our product development efforts in immuno-oncology are equally important. We have demonstrated the potential of our GEN-1 IL-12 immunotherapy program to be an effective adjuvant, in both first and second-line ovarian cancer. Recruiting the immune system to work in combination with the standard of care in this patient population has been the goal of medical researchers worldwide.  With GEN-1, we believe there is the potential for a break-through and we look forward to reporting comprehensive clinical results and translational research data from our Phase 1B OVATION Study at the ASCO Annual Meeting in June 2017." Announced the Publication of Preclinical Results of ThermoDox® for the Treatment of Bladder Cancer in the International Journal of Hyperthermia.  The Company reported results from porcine in vivo studies to evaluate ThermoDox® in combination with loco-regional mild hyperthermia for targeted drug delivery to the bladder wall as a potential treatment for bladder cancer.  Doxorubicin accumulation and distribution within the bladder wall with ThermoDox® plus mild bladder hyperthermia was achieved at concentrations nearly ten times higher than with free intravenous doxorubicin combined with mild bladder hyperthermia. The study was conducted under a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH) to evaluate whether ThermoDox® combined with mild heating of the bladder can target drug delivery in the bladder. Announced Support for the OPTIMA Study from the China FDA and Vietnam Ministry of Health.  The Company discussed ThermoDox® and the OPTIMA Study with regulatory agencies in two key markets, China and Vietnam.  The Company met with the China Food and Drug Administration (CFDA) to review the ongoing Phase III OPTIMA Study and regulatory pathway for ThermoDox® in China. CFDA was presented with the final overall survival data from the Chinese patient cohort of the HEAT study, which demonstrated a survival benefit in patients treated with ThermoDox® plus optimized RFA versus optimized RFA alone. The CFDA informed the Company that if the ongoing Phase III OPTIMA Study is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union which is currently required for foreign company application. This would allow the Company to accelerate its plans for a regulatory filing in China and, if approved, provide for a significantly earlier launch date in China than originally expected. The Company's management team also met with the Ministry of Health in Vietnam and based on that meeting, it will move forward with launching additional trial sites for the OPTIMA Study in that country. The Company plans to activate 5 additional clinical trial sites in Vietnam by the second quarter of 2017. Vietnam represents a significant market for ThermoDox® where HCC incidence rates are among the highest in the world. Announced the Issuance of Two New Patents for ThermoDox.  In January 2017, the Company announced the issuance of two patents which are directly applicable to the method of treating cancer using our current ThermoDox® formulation.  These new patents further strengthen the Company’s global patent portfolio around novel heat-sensitive liposome engineered to address a broad range of difficult-to-treat cancers. Announced Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients.  In January 2017, the Company announced data from the first four cohorts of patients in its Phase Ib 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 debulking surgery.  In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. The efficacy data included highly encouraging tumor response rates - 100% disease control rate (DCR) and 75% objective response rate (ORR), successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels.  In February 2017, the Company presented two posters 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. Raised $6.8 Million Through Two Equity Offerings in December 2016 and February 2017.  The Company completed two equity offerings of shares of common stock, or pre-funded warrants in lieu thereof, to purchase common stock with institutional healthcare and retail investors totaling $6.8 million in gross proceeds. For the quarter ended March 31, 2017, Celsion reported a net loss of $5.2 million, or $0.12 per share, compared to a net loss of $5.7 million, or $0.24 per share, in the same period of 2016. Operating expenses were $4.9 million in the first quarter of 2017 compared to $5.3 million in the same period of 2016.  This decrease was primarily due to lower general and administrative expenses. Research and development (R&D) costs were relatively constant at $3.5 million and $3.4 million in the first quarters of 2017 and 2016, respectively.  Clinical development costs for the Phase III OPTIMA Study were $1.6 million in the first quarter of 2017 compared to $1.0 million in the same period of 2016 due to higher patient enrollment and investigator grant expenses in the trial.  R&D costs for other development programs were lower as a result of the Company’s tighter clinical development focus around the pivotal Phase III OPTIMA Study for the treatment of primary liver cancer and the clinical development program for GEN-1 IL-12 immunotherapy for the localized treatment of ovarian cancer coupled with lower costs in the first quarter of 2017 associated with the production of ThermoDox® clinical supplies to support the OPTIMA Study.  General and administrative expenses decreased $0.4 million, from $1.9 million in the first quarter of 2016 to $1.5 million in the first quarter of 2017.  This 21% decrease in general and administrative expenses in 2017 is primarily the result of reduction in personnel costs and lower professional fees. Net cash used in operations was $3.1 million in the first quarter of 2017 compared to $4.7 million in the same period of 2016.  The Company ended the first quarter of 2017 with $4.5 million of total cash and cash equivalents.  In February 2017, the Company raised $5 million in gross proceeds under a secondary public offering with various institutional and retail investors. The Company is hosting a conference call to provide a business update and discuss year-end 2016 financial results at 11:00 a.m. ET 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 First 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 on the internet at www.celsion.com. The call will be archived for replay on Friday, May 12, 2017 and will remain available until 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 ID: 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. ET 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). 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 12, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced financial results for the quarter ended March 31, 2017 and provided 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 encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein.  The Company's lead program is ThermoDox® which is 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 Company's immunotherapy program consists of GEN-1 and is currently in Phase I development for the localized treatment of ovarian cancer. "Celsion continues to make major progress with respect to our ongoing global, pivotal Phase III OPTIMA Study in primary liver cancer.  This ground-breaking study continues to attract interest and support from the medical community, international regulatory agencies, and research organizations like the National Institutes of Health," said Michael H. Tardugno, Celsion's chairman, president and CEO.  "Our product development efforts in immuno-oncology are equally important. We have demonstrated the potential of our GEN-1 IL-12 immunotherapy program to be an effective adjuvant, in both first and second-line ovarian cancer. Recruiting the immune system to work in combination with the standard of care in this patient population has been the goal of medical researchers worldwide.  With GEN-1, we believe there is the potential for a break-through and we look forward to reporting comprehensive clinical results and translational research data from our Phase 1B OVATION Study at the ASCO Annual Meeting in June 2017." Announced the Publication of Preclinical Results of ThermoDox® for the Treatment of Bladder Cancer in the International Journal of Hyperthermia.  The Company reported results from porcine in vivo studies to evaluate ThermoDox® in combination with loco-regional mild hyperthermia for targeted drug delivery to the bladder wall as a potential treatment for bladder cancer.  Doxorubicin accumulation and distribution within the bladder wall with ThermoDox® plus mild bladder hyperthermia was achieved at concentrations nearly ten times higher than with free intravenous doxorubicin combined with mild bladder hyperthermia. The study was conducted under a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH) to evaluate whether ThermoDox® combined with mild heating of the bladder can target drug delivery in the bladder. Announced Support for the OPTIMA Study from the China FDA and Vietnam Ministry of Health.  The Company discussed ThermoDox® and the OPTIMA Study with regulatory agencies in two key markets, China and Vietnam.  The Company met with the China Food and Drug Administration (CFDA) to review the ongoing Phase III OPTIMA Study and regulatory pathway for ThermoDox® in China. CFDA was presented with the final overall survival data from the Chinese patient cohort of the HEAT study, which demonstrated a survival benefit in patients treated with ThermoDox® plus optimized RFA versus optimized RFA alone. The CFDA informed the Company that if the ongoing Phase III OPTIMA Study is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union which is currently required for foreign company application. This would allow the Company to accelerate its plans for a regulatory filing in China and, if approved, provide for a significantly earlier launch date in China than originally expected. The Company's management team also met with the Ministry of Health in Vietnam and based on that meeting, it will move forward with launching additional trial sites for the OPTIMA Study in that country. The Company plans to activate 5 additional clinical trial sites in Vietnam by the second quarter of 2017. Vietnam represents a significant market for ThermoDox® where HCC incidence rates are among the highest in the world. Announced the Issuance of Two New Patents for ThermoDox.  In January 2017, the Company announced the issuance of two patents which are directly applicable to the method of treating cancer using our current ThermoDox® formulation.  These new patents further strengthen the Company’s global patent portfolio around novel heat-sensitive liposome engineered to address a broad range of difficult-to-treat cancers. Announced Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients.  In January 2017, the Company announced data from the first four cohorts of patients in its Phase Ib 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 debulking surgery.  In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. The efficacy data included highly encouraging tumor response rates - 100% disease control rate (DCR) and 75% objective response rate (ORR), successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels.  In February 2017, the Company presented two posters 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. Raised $6.8 Million Through Two Equity Offerings in December 2016 and February 2017.  The Company completed two equity offerings of shares of common stock, or pre-funded warrants in lieu thereof, to purchase common stock with institutional healthcare and retail investors totaling $6.8 million in gross proceeds. For the quarter ended March 31, 2017, Celsion reported a net loss of $5.2 million, or $0.12 per share, compared to a net loss of $5.7 million, or $0.24 per share, in the same period of 2016. Operating expenses were $4.9 million in the first quarter of 2017 compared to $5.3 million in the same period of 2016.  This decrease was primarily due to lower general and administrative expenses. Research and development (R&D) costs were relatively constant at $3.5 million and $3.4 million in the first quarters of 2017 and 2016, respectively.  Clinical development costs for the Phase III OPTIMA Study were $1.6 million in the first quarter of 2017 compared to $1.0 million in the same period of 2016 due to higher patient enrollment and investigator grant expenses in the trial.  R&D costs for other development programs were lower as a result of the Company’s tighter clinical development focus around the pivotal Phase III OPTIMA Study for the treatment of primary liver cancer and the clinical development program for GEN-1 IL-12 immunotherapy for the localized treatment of ovarian cancer coupled with lower costs in the first quarter of 2017 associated with the production of ThermoDox® clinical supplies to support the OPTIMA Study.  General and administrative expenses decreased $0.4 million, from $1.9 million in the first quarter of 2016 to $1.5 million in the first quarter of 2017.  This 21% decrease in general and administrative expenses in 2017 is primarily the result of reduction in personnel costs and lower professional fees. Net cash used in operations was $3.1 million in the first quarter of 2017 compared to $4.7 million in the same period of 2016.  The Company ended the first quarter of 2017 with $4.5 million of total cash and cash equivalents.  In February 2017, the Company raised $5 million in gross proceeds under a secondary public offering with various institutional and retail investors. The Company is hosting a conference call to provide a business update and discuss year-end 2016 financial results at 11:00 a.m. ET 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 First 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 on the internet at www.celsion.com. The call will be archived for replay on Friday, May 12, 2017 and will remain available until 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 ID: 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. ET 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). 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 12, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced financial results for the quarter ended March 31, 2017 and provided 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 encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein.  The Company's lead program is ThermoDox® which is 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 Company's immunotherapy program consists of GEN-1 and is currently in Phase I development for the localized treatment of ovarian cancer. "Celsion continues to make major progress with respect to our ongoing global, pivotal Phase III OPTIMA Study in primary liver cancer.  This ground-breaking study continues to attract interest and support from the medical community, international regulatory agencies, and research organizations like the National Institutes of Health," said Michael H. Tardugno, Celsion's chairman, president and CEO.  "Our product development efforts in immuno-oncology are equally important. We have demonstrated the potential of our GEN-1 IL-12 immunotherapy program to be an effective adjuvant, in both first and second-line ovarian cancer. Recruiting the immune system to work in combination with the standard of care in this patient population has been the goal of medical researchers worldwide.  With GEN-1, we believe there is the potential for a break-through and we look forward to reporting comprehensive clinical results and translational research data from our Phase 1B OVATION Study at the ASCO Annual Meeting in June 2017." Announced the Publication of Preclinical Results of ThermoDox® for the Treatment of Bladder Cancer in the International Journal of Hyperthermia.  The Company reported results from porcine in vivo studies to evaluate ThermoDox® in combination with loco-regional mild hyperthermia for targeted drug delivery to the bladder wall as a potential treatment for bladder cancer.  Doxorubicin accumulation and distribution within the bladder wall with ThermoDox® plus mild bladder hyperthermia was achieved at concentrations nearly ten times higher than with free intravenous doxorubicin combined with mild bladder hyperthermia. The study was conducted under a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH) to evaluate whether ThermoDox® combined with mild heating of the bladder can target drug delivery in the bladder. Announced Support for the OPTIMA Study from the China FDA and Vietnam Ministry of Health.  The Company discussed ThermoDox® and the OPTIMA Study with regulatory agencies in two key markets, China and Vietnam.  The Company met with the China Food and Drug Administration (CFDA) to review the ongoing Phase III OPTIMA Study and regulatory pathway for ThermoDox® in China. CFDA was presented with the final overall survival data from the Chinese patient cohort of the HEAT study, which demonstrated a survival benefit in patients treated with ThermoDox® plus optimized RFA versus optimized RFA alone. The CFDA informed the Company that if the ongoing Phase III OPTIMA Study is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union which is currently required for foreign company application. This would allow the Company to accelerate its plans for a regulatory filing in China and, if approved, provide for a significantly earlier launch date in China than originally expected. The Company's management team also met with the Ministry of Health in Vietnam and based on that meeting, it will move forward with launching additional trial sites for the OPTIMA Study in that country. The Company plans to activate 5 additional clinical trial sites in Vietnam by the second quarter of 2017. Vietnam represents a significant market for ThermoDox® where HCC incidence rates are among the highest in the world. Announced the Issuance of Two New Patents for ThermoDox.  In January 2017, the Company announced the issuance of two patents which are directly applicable to the method of treating cancer using our current ThermoDox® formulation.  These new patents further strengthen the Company’s global patent portfolio around novel heat-sensitive liposome engineered to address a broad range of difficult-to-treat cancers. Announced Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients.  In January 2017, the Company announced data from the first four cohorts of patients in its Phase Ib 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 debulking surgery.  In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. The efficacy data included highly encouraging tumor response rates - 100% disease control rate (DCR) and 75% objective response rate (ORR), successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels.  In February 2017, the Company presented two posters 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. Raised $6.8 Million Through Two Equity Offerings in December 2016 and February 2017.  The Company completed two equity offerings of shares of common stock, or pre-funded warrants in lieu thereof, to purchase common stock with institutional healthcare and retail investors totaling $6.8 million in gross proceeds. For the quarter ended March 31, 2017, Celsion reported a net loss of $5.2 million, or $0.12 per share, compared to a net loss of $5.7 million, or $0.24 per share, in the same period of 2016. Operating expenses were $4.9 million in the first quarter of 2017 compared to $5.3 million in the same period of 2016.  This decrease was primarily due to lower general and administrative expenses. Research and development (R&D) costs were relatively constant at $3.5 million and $3.4 million in the first quarters of 2017 and 2016, respectively.  Clinical development costs for the Phase III OPTIMA Study were $1.6 million in the first quarter of 2017 compared to $1.0 million in the same period of 2016 due to higher patient enrollment and investigator grant expenses in the trial.  R&D costs for other development programs were lower as a result of the Company’s tighter clinical development focus around the pivotal Phase III OPTIMA Study for the treatment of primary liver cancer and the clinical development program for GEN-1 IL-12 immunotherapy for the localized treatment of ovarian cancer coupled with lower costs in the first quarter of 2017 associated with the production of ThermoDox® clinical supplies to support the OPTIMA Study.  General and administrative expenses decreased $0.4 million, from $1.9 million in the first quarter of 2016 to $1.5 million in the first quarter of 2017.  This 21% decrease in general and administrative expenses in 2017 is primarily the result of reduction in personnel costs and lower professional fees. Net cash used in operations was $3.1 million in the first quarter of 2017 compared to $4.7 million in the same period of 2016.  The Company ended the first quarter of 2017 with $4.5 million of total cash and cash equivalents.  In February 2017, the Company raised $5 million in gross proceeds under a secondary public offering with various institutional and retail investors. The Company is hosting a conference call to provide a business update and discuss year-end 2016 financial results at 11:00 a.m. ET 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 First 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 on the internet at www.celsion.com. The call will be archived for replay on Friday, May 12, 2017 and will remain available until 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 ID: 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. ET 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). 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 12, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced financial results for the quarter ended March 31, 2017 and provided 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 encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein.  The Company's lead program is ThermoDox® which is 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 Company's immunotherapy program consists of GEN-1 and is currently in Phase I development for the localized treatment of ovarian cancer. "Celsion continues to make major progress with respect to our ongoing global, pivotal Phase III OPTIMA Study in primary liver cancer.  This ground-breaking study continues to attract interest and support from the medical community, international regulatory agencies, and research organizations like the National Institutes of Health," said Michael H. Tardugno, Celsion's chairman, president and CEO.  "Our product development efforts in immuno-oncology are equally important. We have demonstrated the potential of our GEN-1 IL-12 immunotherapy program to be an effective adjuvant, in both first and second-line ovarian cancer. Recruiting the immune system to work in combination with the standard of care in this patient population has been the goal of medical researchers worldwide.  With GEN-1, we believe there is the potential for a break-through and we look forward to reporting comprehensive clinical results and translational research data from our Phase 1B OVATION Study at the ASCO Annual Meeting in June 2017." Announced the Publication of Preclinical Results of ThermoDox® for the Treatment of Bladder Cancer in the International Journal of Hyperthermia.  The Company reported results from porcine in vivo studies to evaluate ThermoDox® in combination with loco-regional mild hyperthermia for targeted drug delivery to the bladder wall as a potential treatment for bladder cancer.  Doxorubicin accumulation and distribution within the bladder wall with ThermoDox® plus mild bladder hyperthermia was achieved at concentrations nearly ten times higher than with free intravenous doxorubicin combined with mild bladder hyperthermia. The study was conducted under a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH) to evaluate whether ThermoDox® combined with mild heating of the bladder can target drug delivery in the bladder. Announced Support for the OPTIMA Study from the China FDA and Vietnam Ministry of Health.  The Company discussed ThermoDox® and the OPTIMA Study with regulatory agencies in two key markets, China and Vietnam.  The Company met with the China Food and Drug Administration (CFDA) to review the ongoing Phase III OPTIMA Study and regulatory pathway for ThermoDox® in China. CFDA was presented with the final overall survival data from the Chinese patient cohort of the HEAT study, which demonstrated a survival benefit in patients treated with ThermoDox® plus optimized RFA versus optimized RFA alone. The CFDA informed the Company that if the ongoing Phase III OPTIMA Study is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union which is currently required for foreign company application. This would allow the Company to accelerate its plans for a regulatory filing in China and, if approved, provide for a significantly earlier launch date in China than originally expected. The Company's management team also met with the Ministry of Health in Vietnam and based on that meeting, it will move forward with launching additional trial sites for the OPTIMA Study in that country. The Company plans to activate 5 additional clinical trial sites in Vietnam by the second quarter of 2017. Vietnam represents a significant market for ThermoDox® where HCC incidence rates are among the highest in the world. Announced the Issuance of Two New Patents for ThermoDox.  In January 2017, the Company announced the issuance of two patents which are directly applicable to the method of treating cancer using our current ThermoDox® formulation.  These new patents further strengthen the Company’s global patent portfolio around novel heat-sensitive liposome engineered to address a broad range of difficult-to-treat cancers. Announced Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients.  In January 2017, the Company announced data from the first four cohorts of patients in its Phase Ib 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 debulking surgery.  In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. The efficacy data included highly encouraging tumor response rates - 100% disease control rate (DCR) and 75% objective response rate (ORR), successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels.  In February 2017, the Company presented two posters 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. Raised $6.8 Million Through Two Equity Offerings in December 2016 and February 2017.  The Company completed two equity offerings of shares of common stock, or pre-funded warrants in lieu thereof, to purchase common stock with institutional healthcare and retail investors totaling $6.8 million in gross proceeds. For the quarter ended March 31, 2017, Celsion reported a net loss of $5.2 million, or $0.12 per share, compared to a net loss of $5.7 million, or $0.24 per share, in the same period of 2016. Operating expenses were $4.9 million in the first quarter of 2017 compared to $5.3 million in the same period of 2016.  This decrease was primarily due to lower general and administrative expenses. Research and development (R&D) costs were relatively constant at $3.5 million and $3.4 million in the first quarters of 2017 and 2016, respectively.  Clinical development costs for the Phase III OPTIMA Study were $1.6 million in the first quarter of 2017 compared to $1.0 million in the same period of 2016 due to higher patient enrollment and investigator grant expenses in the trial.  R&D costs for other development programs were lower as a result of the Company’s tighter clinical development focus around the pivotal Phase III OPTIMA Study for the treatment of primary liver cancer and the clinical development program for GEN-1 IL-12 immunotherapy for the localized treatment of ovarian cancer coupled with lower costs in the first quarter of 2017 associated with the production of ThermoDox® clinical supplies to support the OPTIMA Study.  General and administrative expenses decreased $0.4 million, from $1.9 million in the first quarter of 2016 to $1.5 million in the first quarter of 2017.  This 21% decrease in general and administrative expenses in 2017 is primarily the result of reduction in personnel costs and lower professional fees. Net cash used in operations was $3.1 million in the first quarter of 2017 compared to $4.7 million in the same period of 2016.  The Company ended the first quarter of 2017 with $4.5 million of total cash and cash equivalents.  In February 2017, the Company raised $5 million in gross proceeds under a secondary public offering with various institutional and retail investors. The Company is hosting a conference call to provide a business update and discuss year-end 2016 financial results at 11:00 a.m. ET 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 First 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 on the internet at www.celsion.com. The call will be archived for replay on Friday, May 12, 2017 and will remain available until 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 ID: 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. ET 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). 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 12, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced financial results for the quarter ended March 31, 2017 and provided 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 encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein.  The Company's lead program is ThermoDox® which is 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 Company's immunotherapy program consists of GEN-1 and is currently in Phase I development for the localized treatment of ovarian cancer. "Celsion continues to make major progress with respect to our ongoing global, pivotal Phase III OPTIMA Study in primary liver cancer.  This ground-breaking study continues to attract interest and support from the medical community, international regulatory agencies, and research organizations like the National Institutes of Health," said Michael H. Tardugno, Celsion's chairman, president and CEO.  "Our product development efforts in immuno-oncology are equally important. We have demonstrated the potential of our GEN-1 IL-12 immunotherapy program to be an effective adjuvant, in both first and second-line ovarian cancer. Recruiting the immune system to work in combination with the standard of care in this patient population has been the goal of medical researchers worldwide.  With GEN-1, we believe there is the potential for a break-through and we look forward to reporting comprehensive clinical results and translational research data from our Phase 1B OVATION Study at the ASCO Annual Meeting in June 2017." Announced the Publication of Preclinical Results of ThermoDox® for the Treatment of Bladder Cancer in the International Journal of Hyperthermia.  The Company reported results from porcine in vivo studies to evaluate ThermoDox® in combination with loco-regional mild hyperthermia for targeted drug delivery to the bladder wall as a potential treatment for bladder cancer.  Doxorubicin accumulation and distribution within the bladder wall with ThermoDox® plus mild bladder hyperthermia was achieved at concentrations nearly ten times higher than with free intravenous doxorubicin combined with mild bladder hyperthermia. The study was conducted under a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH) to evaluate whether ThermoDox® combined with mild heating of the bladder can target drug delivery in the bladder. Announced Support for the OPTIMA Study from the China FDA and Vietnam Ministry of Health.  The Company discussed ThermoDox® and the OPTIMA Study with regulatory agencies in two key markets, China and Vietnam.  The Company met with the China Food and Drug Administration (CFDA) to review the ongoing Phase III OPTIMA Study and regulatory pathway for ThermoDox® in China. CFDA was presented with the final overall survival data from the Chinese patient cohort of the HEAT study, which demonstrated a survival benefit in patients treated with ThermoDox® plus optimized RFA versus optimized RFA alone. The CFDA informed the Company that if the ongoing Phase III OPTIMA Study is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union which is currently required for foreign company application. This would allow the Company to accelerate its plans for a regulatory filing in China and, if approved, provide for a significantly earlier launch date in China than originally expected. The Company's management team also met with the Ministry of Health in Vietnam and based on that meeting, it will move forward with launching additional trial sites for the OPTIMA Study in that country. The Company plans to activate 5 additional clinical trial sites in Vietnam by the second quarter of 2017. Vietnam represents a significant market for ThermoDox® where HCC incidence rates are among the highest in the world. Announced the Issuance of Two New Patents for ThermoDox.  In January 2017, the Company announced the issuance of two patents which are directly applicable to the method of treating cancer using our current ThermoDox® formulation.  These new patents further strengthen the Company’s global patent portfolio around novel heat-sensitive liposome engineered to address a broad range of difficult-to-treat cancers. Announced Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients.  In January 2017, the Company announced data from the first four cohorts of patients in its Phase Ib 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 debulking surgery.  In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. The efficacy data included highly encouraging tumor response rates - 100% disease control rate (DCR) and 75% objective response rate (ORR), successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels.  In February 2017, the Company presented two posters 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. Raised $6.8 Million Through Two Equity Offerings in December 2016 and February 2017.  The Company completed two equity offerings of shares of common stock, or pre-funded warrants in lieu thereof, to purchase common stock with institutional healthcare and retail investors totaling $6.8 million in gross proceeds. For the quarter ended March 31, 2017, Celsion reported a net loss of $5.2 million, or $0.12 per share, compared to a net loss of $5.7 million, or $0.24 per share, in the same period of 2016. Operating expenses were $4.9 million in the first quarter of 2017 compared to $5.3 million in the same period of 2016.  This decrease was primarily due to lower general and administrative expenses. Research and development (R&D) costs were relatively constant at $3.5 million and $3.4 million in the first quarters of 2017 and 2016, respectively.  Clinical development costs for the Phase III OPTIMA Study were $1.6 million in the first quarter of 2017 compared to $1.0 million in the same period of 2016 due to higher patient enrollment and investigator grant expenses in the trial.  R&D costs for other development programs were lower as a result of the Company’s tighter clinical development focus around the pivotal Phase III OPTIMA Study for the treatment of primary liver cancer and the clinical development program for GEN-1 IL-12 immunotherapy for the localized treatment of ovarian cancer coupled with lower costs in the first quarter of 2017 associated with the production of ThermoDox® clinical supplies to support the OPTIMA Study.  General and administrative expenses decreased $0.4 million, from $1.9 million in the first quarter of 2016 to $1.5 million in the first quarter of 2017.  This 21% decrease in general and administrative expenses in 2017 is primarily the result of reduction in personnel costs and lower professional fees. Net cash used in operations was $3.1 million in the first quarter of 2017 compared to $4.7 million in the same period of 2016.  The Company ended the first quarter of 2017 with $4.5 million of total cash and cash equivalents.  In February 2017, the Company raised $5 million in gross proceeds under a secondary public offering with various institutional and retail investors. The Company is hosting a conference call to provide a business update and discuss year-end 2016 financial results at 11:00 a.m. ET 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 First 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 on the internet at www.celsion.com. The call will be archived for replay on Friday, May 12, 2017 and will remain available until 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 ID: 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. ET 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). 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 | May 19, 2017
Site: www.eurekalert.org

Rush University Medical Center is among the first hospitals in the nation, and the only one in Illinois, to provide patients fighting advanced kidney access to a new combination immunotherapy that targets different immune system cells and processes than a widely used therapy that has been proven effective for some patients but had little effect on others. "Ten years ago, patients with advanced kidney cancer had few options and little hope. But just in the last few years, new drug combinations have resulted in long-lasting remission for many, but more investigations need to be done to help those kidney cancer patients who have not yet benefited," said Dr. Timothy Kuzel, Rush's chief of Hematology, Oncology and Cell Therapy and the clinical trial's principal investigator. Patients over the age of 18 who have been diagnosed with renal cell carcinoma -- the most common form of kidney cancer -- that has metastasized, or spread, are potential candidates for this investigational therapy. The nationwide, multisite phase two clinical trial, titled FRACTION-RCC, is designed to test whether the new immunotherapy combination (combining nnivolumab with other investigational immunotherapy agents) is more effective than the currently used drug combination (nivolumab and ipilimumab) that has become an important kidney cancer treatment in recent years. While the current immunotherapy drugs have proven to extend kidney cancer patients' survival rate and enhance quality of life for some patients, many patient have no response at all. The American Cancer Society estimates that 14,000 Americans died of kidney cancer in 2016, and more than 63,000 of new cases were diagnosed. Surgery has been the standard treatment for kidney cancer for decades because the disease is often resistant to both chemotherapy and radiation. And while a class of drugs known as immune modulators has been used successfully on a small percentage of kidney cancer patients since the 1990s, the approval of new drugs including nivolumab in 2015 and subsequent use of the nivolumab in combination with another drug, ipilimumab, have made treatments that use a patient's immune system potentially the most effective treatment option. Both nivolumab and ipilimumab are monoclonal) antibodies which help the immune system's main weapon, called T cells, to detect and destroy diseased or infected cells. Nivolumab helps block the molecular signals that cancer cells send to fool the immune system into not recognizing them as a threat, while ipilimumab targets a protein cancer cells use to signal the body to produce fewer T cells. "Nivolumab removes the brakes that cancer cells have put on the immune system, while ipilimumab steps on the gas and accelerates the production of T cells," Kuzel explains. "But we know this combination doesn't work for everyone and that there are several other potential targets that activate the immune system's tumor-fighting capabilities. Thus we're excited about the new study to learn whether a series of novel immunotherapy combinations -- immunotherapy cocktails -- can be integrated into kidney cancer treatments." The new clinical trial adds to Rush's wider research efforts towards identifying immune system biomarkers that can help oncologists predict which immunotherapy is best suited for individual patients battling several types of cancer. Blood samples of many cancer patients undergoing immunotherapy treatments at Rush are analyzed to measure immune biomarkers secreted by the tumor detected in peripheral blood mononuclear cells, a critical component of the immune system. A biomarker is a biological substance that can indicate the presence of a disease, or predict how well someone may respond to a treatment. But because of the complex interactions between the immune system and a tumor, immune-biomarkers are more difficult to identify. "Most cancer biomarkers, such as specific genetic mutations or proteins, are binary -- they are either present or not. But as we better measure and understand the intricate ways in which our immune system and cancer cells do battle, the quicker we can develop new ways for more people to activate their immune systems to win that battle." Kuzel added. Kuzel has led the development of a series of immune-oncology therapies, authored or co-authored more than 250 journal articles, editorials and book chapters, and oversaw in 2016 the Society for Immunotherapy of Cancer's regional Immunotherapy 101 program designed to help clinical oncologists integrate immunotherapies into the clinical management for their patients. Learn more about the full range of Rush University Medical Center's cancer care and research.


News Article | February 17, 2017
Site: globenewswire.com

GOTHENBURG, Sweden, February 17, 2017 - Immunicum AB (publ; First North Premier: IMMU.ST) a biopharmaceutical company advancing a novel immuno-oncology treatment against a range of solid tumors, today announced financial results for the year ended December 31, 2016 and provided a corporate update and overview of the Company's activities. Carlos de Sousa, MD, CEO of Immunicum, will conduct a webcast and conference call to present the update today at 10:00 am CET. Information for joining the webcast and call are listed at the end of this press release. Significant events during the second quarter year On October 26, 2016, the Annual General Meeting ("AGM") of Immunicum AB elected Steven Glazer, Charlotte Edenius and Kerstin Valinder Strinnholm as new Board members. Agneta Edberg, Martin Lindström, Magnus Nilsson and Magnus Persson were all re-elected as Board members. Bengt Furberg declined re-election. Agneta Edberg was re-elected as Chairman of the Board. The AGM also resolved to authorize the Board of Directors to, on one or several occasions during the period until the next Annual General Meeting, with or without deviation from the shareholder's preferential rights, resolve on new share issues of a maximum of 5,040,000 shares. AGM also resolved to change the fiscal year of the Company to calendar year as well as to shorten the current fiscal year to cover the period July 1, 2016 - December 31, 2016. On November 14, 2016, at the Society for Immunotherapy of Cancer (SITC) 31st Annual Meeting, Immunicum presented updated immunological and survival phase I/II data on hepatocellular carcinoma (HCC) patients treated with INTUVAX®. Data showed that 67% of fully treated patients with advanced HCC experienced increases in circulating tumor-specific CD8+ T cells and that these increases appear to correlate with prolonged survival rates seen in the study as compared to historical median overall survival rates. It was furthermore announced that all six additional patients in an extension of the study had been included. These patients received INTUVAX® as first line systemic treatment in combination with standard treatments. On December 13, 2016, Immunicum announced that the United States Food and Drug Administration (FDA) had cleared the Company's Investigational New Drug application (IND) for INTUVAX®. The IND clearance enables Immunicum to expand its ongoing phase II study - MERECA (MEtastatic REnal Cell CArcinoma) - for the treatment of metastatic renal cell cancer patients, into the United States. Significant events after the financial year In February 2017, the Company announced the appointment of Karin Hoogendoorn as Head of Chemistry Manufacturing and Controls (CMC). Dr. Hoogendoorn is a seasoned expert in the development of biotechnological products and has lead successful CMC efforts for a variety of products within positions at Novartis AG, Janssen Biologics BV and Crucell Holland and will be critical for the high quality production of Immunicum's products. In February 2017, the Company announced that the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in France has approved the Company's Clinical Trial Application (CTA) for INTUVAX®. The CTA approval enables Immunicum to include patients in France in its ongoing phase II study - MERECA (MEtastatic REnal Cell CArcinoma) - for the treatment of metastatic renal cell cancer. Second quarter (October-December) 2016 compared with the same period in 2015 Financial year (July-December) 2016 compared with the same period in 2015 It is an exciting moment for Immunicum as we prepare for a transformative year in 2017. In addition to advancing our ongoing clinical trials for INTUVAX® and strengthening our leadership team at Immunicum, we continue to refine our near-term objectives for the overall development of our programs and to review all the Company's activities to ensure that we have the right team, right resources and right focus in place to build the most value for our investors. Since the Company's inception, Immunicum has achieved the clinical stage development of a promising immuno-oncology therapeutic approach for treating a range of solid tumors. It is a major achievement for a small organization like Immunicum to bring a discovery into multiple clinical trials. It goes without saying that immuno-oncology is one of the most exciting areas of pharmaceutical discovery and development, with the first approved drugs proving the value of the concept that a key way to fight cancer is to re-activate the patient's own immune system to destroy cancerous cells. Immunicum has a unique approach to immune-oncology and we believe that it has the potential to become an important part of treating solid tumors in the future. Our strategy remains to advance our programs successfully into the clinic and ensure the success of these trials. The following is an overview of the most up-to-date information from the INTUVAX® trials in kidney and liver cancer as well as GIST (gastrointestinal stromal tumor). Renal Cell Carcinoma (RCC): The enrollment process for the ongoing MERECA phase II study, where patients with newly diagnosed metastatic renal cell carcinoma are treated with INTUVAX® in combination with sunitinib, has been implemented across Europe. To date, a total of 43 patients have been enrolled at 18 centers in seven European countries. The primary purpose of the MERECA trial is to examine safety as well as clinical benefit in terms of survival rate at 18 months and median overall survival for all patients. The Company will also study the objective tumor response after initiating treatment with sunitinib, as well as study intratumoral infiltration of CD8+ T cells. In the context of this open-label trial, we can report that safety remains positive and that levels of infiltration are in line with what we have seen previously, however, it is still too early to make any further interpretation of data. We will present all these data as well as those from the continued follow-up of the patients from the phase I/II trial in RCC in due course at scientific conferences and in peer-reviewed scientific journals. We announced in December that our Investigational New Drug (IND) application to the Food and Drug Administration (FDA) has been cleared to start enrolling kidney cancer patients in the U.S. as part of the MERECA trial. We anticipate to start this process in the second quarter of 2017. To support this goal, we have optimized the production of the product at a large manufacturing facility in Germany. This has been a positive development for the ongoing trial in EU as well as our preparation for the start of the enrollment in the US. Hepatocellular Carcinoma (HCC): In November 2016 we provided updated immunological and survival data from our clinical phase I/II study in patients with advanced hepatocellular carcinoma which were presented at the Society for Immunotherapy of Cancer's (SITC) annual meeting. The data showed that 67% of fully treated patients with advanced HCC experienced increases in circulating tumor-specific CD8+ T cells. These increases appear to correlate with the prolonged survival rates seen in the study as compared to historical median overall survival rates. In the extension of the study we have now enrolled the last of the six additional liver cancer patients that received INTUVAX® concomitantly with first line standard of care medication. Gastrointestinal Stromal Tumors (GIST): As previously reported, the first patient has been included in our clinical phase I/II study with INTUVAX® in patients with GIST. Because the disease is both rare and complex, we have revised the study protocol in collaboration with the investigators at the Karolinska Institute, and this protocol has been reviewed and approved by the National Authorities and Ethical committee. Clinical Development Plan Analysis: The important information that we will gain from these ongoing trials will complement our ongoing analysis of the cancer treatment landscape to determine the most successful path for INTUVAX®. The most critical decisions here involve considering which indications we should select for the later stage clinical development of the program. There are several aspects to consider: patient need, clinical endpoints for the trial and overall success potential for regulatory approval. Over the last several months, we have considered the possibility of expanding the development plan with additional phase I/ II studies in different indications, such as melanoma, and in different combinations, e.g. with immune checkpoint inhibitors. These considerations are still underway and we look forward to providing an update on them in the near future. Development Programs and Academic Collaborations: Immunicum's major focus is to advance the ongoing clinical studies with INTUVAX®, however, we will continue to invest into deeper investigation of two of our earlier stage applications: CD70 and the adenovirus vector program, where the development is conducted in collaboration with professor Magnus Essand at Uppsala University. For CD70, we are currently evaluating the possibilities for clinical production and for the vector, we are currently conducting preclinical studies within the concept of SUBCUVAX. These efforts will allow us to build additional value from the research conducted to date. Corporate and Organizational Updates: We had the pleasure of announcing the addition of Karin Hoogendoorn as Head of CMC. We will continue to strengthen our leadership team with expertise in product development and production, regulatory strategy and business development to reinforce the strength of the current leadership and build a company well-positioned to succeed. Ongoing Communications Activities: We will continue to place a focus on providing regular updates to our shareholders as well as raising the profile of the Company both through industry and financial events as well as scientific and medical conferences. We will be announcing our participation in conferences in Sweden, Europe and in the US on a more frequent basis. Our vision for the Company is to increase our interaction within the larger biopharmaceutical industry while maintaining our operational focus on the further development of our programs. About Immunicum AB (publ) Immunicum AB (First North Premier: IMMU.ST) is a clinical stage company developing novel immuno-oncology therapies against a range of solid tumors. The Company's lead compound, INTUVAX® is currently being evaluated in clinical trials for the treatment of kidney cancer, liver cancer and gastrointestinal stromal tumors. INTUVAX® was designed to combine the best of two worlds: a cost-effective cell-based (allogeneic) and off-the-shelf therapy that is capable of triggering a highly personalized and potentially long-lasting immune response against tumor cells throughout the body. www.immunicum.com For more information, please contact Carlos de Sousa, CEO, Immunicum Ph: +46 (0) 31 41 50 52 E-mail: info@immunicum.com The information in this press release is disclosed pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the company's contact person on February 17, 2017 at 7:30 CET


EAGAN, Minn., Feb. 24, 2017 (GLOBE NEWSWIRE) -- Biothera Pharmaceuticals, Inc. will present data today from all cohorts (total N=36) enrolled in a healthy human volunteer study of Imprime PGG, the Company’s phase 2 cancer immunotherapy. The findings showed that administration of Imprime PGG to healthy human subjects results in immunopharmacodynamic (IPD) responses previously associated with the anti-tumor responses in ex vivo human and in vivo mouse studies. This is the first clinical study to show that Imprime PGG responsiveness is dependent upon the formation of an immune complex between Imprime PGG and endogenous anti-beta glucan antibodies (ABA). The results were delivered in a poster presentation at the American Society of Clinical Oncology (ASCO) - Society for Immunotherapy of Cancer (SITC) Clinical Immuno-Oncology Symposium being held from February 23 – 25, 2017 in Orlando, FL. “Our pre-clinical data in human donor blood had suggested the importance of ABA levels for Imprime-based innate immune activation. Before proceeding to further phase 2 studies, we wanted to explore the relationship between pre-treatment ABA levels and response to Imprime PGG,” said Jeremy R. Graff, Ph.D., Chief Scientific Officer and Senior Vice President, Research at Biothera Pharmaceuticals. “These data now support the use of ABA levels as a pre-treatment biomarker to select patients most likely to respond to Imprime PGG-based therapy for our phase 2 studies.” The Company is conducting a phase 2 clinical study to evaluate Imprime PGG in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with either advanced melanoma or metastatic triple negative breast cancer. Biothera will test this therapeutic combination in a phase 2 head and neck cancer study, in collaboration with Merck, that is expected to begin in the third quarter of 2017. Pre-treatment ABA levels will be used to pre-select patients for inclusion in these trials. The Biothera Pharmaceuticals poster, Effect of Imprime PGG on Innate Immune-Activating Pharmacodynamic Changes in a Phase I Clinical Study in Healthy Human Volunteers (Abstract 33), will be presented today between 11:30 am-1:00 pm and 5:30 pm-6:30 pm on Board D6 in Poster Session B. About Biothera Pharmaceuticals, Inc. Biothera Pharmaceuticals is a privately held biotechnology company developing Imprime PGG, a Phase 2 cancer immunotherapy that enhances the efficacy of anti-cancer immune response in combination with immune checkpoint inhibitor, tumor-targeting and anti-angiogenesis antibodies.  Biothera Pharmaceuticals has clinical research agreements with Merck to evaluate Imprime PGG and KEYTRUDA in Phase 2 studies in advanced melanoma, metastatic triple negative breast cancer, and head and neck squamous cell cancer. This therapeutic combination also is the focus of a Big Ten Cancer Research Consortium Phase 1b/2 trial in patients with non-small cell lung cancer. Imprime PGG has been well-tolerated and has established proof of concept in trials with more than 400 subjects. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


SUZHOU, China--(BUSINESS WIRE)--Suzhou-based MabSpace Biosciences announced that the preclinical data for its lead program MSB2311, a 2nd generation humanized PD-L1 blocking antibody with a unique pH-dependent antigen binding property, will be presented at the upcoming 2017 Inaugural American Society of Clinical Oncology (ASCO)-Society for Immunotherapy of Cancer (SITC) Annual Meeting on February 23rd-25th, 2017 in Orlando, Florida, US. The data provide a body of evidence that MSB2311 has significantly higher activities in inducing complete responses in humanized syngeneic tumor models than existing PD-L1 antibodies on the market at both low and high doses. MSB2311 has the potential of being a best-in-class PD-L1 antibody in achieving better efficacy and safety profile with lower doses required. MabSpace is scheduled to present a poster on Thursday, February 23rd with the title of “Characterization of a Humanized PD-L1 Blocking Antibody with pH-Dependent Antigen Binding in a Humanized Syngeneic Tumor Model” by Qian et al., Abstract 177907, Poster #81, Board C10, 11:30-1:00 PM & 5:30PM-6:30 PM. “Developing well-differentiated, lifesaving and highly affordable therapeutics is our mission. Using our proprietary immune tolerance breaking technology we generated a novel antibody with pH-dependent PD-L1 binding that can recycle within the tumor,” commented Xueming Qian, Ph.D., Founder, Chairman and CEO, MabSpace Biosciences. “This differentiated property of MSB2311 presents an opportunity to provide cancer patients with an agent of better efficacy and safety profile than existing PD-L1 antibodies yet highly affordable. We are honored to be selected for presentation and look forward to sharing our data at this inaugural ASCO-SITC meeting.” MabSpace plans to start FIH study for MSB2311 later this year. MSB2311 is the first therapeutic antibody in its pipeline which consists of a panel of antibodies targeting various components of the tumor microenvironment, including both antagonistic and agonist antibodies. MabSpace plans to move two antibody programs to IND filing each year. These agents will allow MabSpace to develop its proprietary combinations for the treatment of cancer. MabSpace will focus on the development in China and find partners for ex-China development of these agents. MabSpace Biosciences is a biotechnology company focused on the discovery and development of antibody therapeutics for oncology and fibrotic disorders leveraging its immune tolerance breaking technology (IMBT)-based antibody discovery platform and translational sciences capability. This technology enables the generation of antibodies with diverse target binding epitopes and well differentiated properties. MabSpace is headquartered in BioBay, Suzhou Industrial Park, China and has an R&D facility with fully-integrated in vitro and in vivo pharmacology profiling capabilities. Visit http://www.mabspacebio.com for more information.


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

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