Celsion Corporation Announces Positive Interim Data From Its Phase 2 DIGNITY Study In Breast Cancer
ThermoDox® Continues to Demonstrate Impressive Local Response Rate in Highly Refractory Patients
Company to Initiate Euro-DIGNITY Trial This Quarter
European Early Access Program Set to Launch This Month
LAWRENCEVILLE, N.J., April 15, 2015 /PRNewswire/ -- Celsion Corporation (CLSN) announced today positive interim data from its ongoing open-label Phase 2 DIGNITY Trial of ThermoDox® in recurrent chest wall (RCW) breast cancer. The trial is designed to enroll up to 20 patients at several U.S. clinical sites and is evaluating ThermoDox in combination with mild hyperthermia. Of the 16 patients enrolled and treated, 12 were eligible for evaluation of efficacy. Based on data available to date, 67% of patients experienced a clinical benefit of their highly refractory disease with a local response rate of 58% observed in the 12 evaluable patients, notably 5 complete responses (CR), 2 partial responses (PR) and 1 patient with stable disease (SD). The Company remains on track to complete enrollment in the study in the third quarter of 2015.
"The objective tumor response data including 5 complete responses emerging from the Phase 2 DIGNITY study are extremely impressive, particularly since the patients in the trial presented with highly resistant chest wall tumors that had progressed on multiple therapies, including chemotherapy, radiation and hormone therapy," noted Dr. Nicholas Borys, Celsion's Senior Vice President and Chief Medical Officer. "Together with the data from earlier Phase 1 studies, these interim results highlight the significant potential of ThermoDox® plus hyperthermia to stabilize disease in this difficult-to-treat patient population, and we look forward to bringing this trial to completion later this year."
These data are consistent with the previously reported Phase 1 data for ThermoDox® plus hyperthermia in RCW breast cancer, including combined clinical data from the Company's Phase 1 DIGNITY Study and a Duke University sponsored Phase 1 trial of ThermoDox®. The two similarly designed studies enrolled patients with highly resistant tumors found on the chest wall and who had progressed on previous therapies. There were 29 patients treated in the two trials, representing 11 patients in the DIGNITY study and 18 patients in the Duke study. Of the 29 patients treated, 23 were eligible for evaluation of efficacy. A local response rate of over 60% was reported in 14 of the 23 evaluable patients, with 5 complete responses and 9 partial responses.
"We are leveraging the remarkable data from our ThermoDox® program in RCW breast cancer to accelerate the development and commercialization of ThermoDox® in this indication in Europe," stated Michael H. Tardugno, Celsion's chairman, president and CEO. "The strength of the DIGNITY data is driving investigator interest in Europe and forming the basis for our Euro-DIGNITY trial, which is set to begin later this quarter. In addition, we are committed to providing patients who are suffering from this aggressive form of breast cancer with access to ThermoDox®, and continue to work closely with myTomorrows to launch an Early Access Program in Europe for ThermoDox® in RCW breast cancer."
The Euro-DIGNITY trial will evaluate ThermoDox® plus hyperthermia in RCW breast cancer patients and is designed to support a registration filing in Europe. This study will be conducted in five countries with the support of key European investigators and with assistance from MedLogics Corporation, an Italian-based hyperthermia device company. In addition, Celsion has a license and distribution agreement with myTomorrows to implement an Early Access Program (EAP) for ThermoDox® in all countries of the European Union territory plus Switzerland for the treatment of patients with RCW breast cancer. The Company expects to have ThermoDox® available for sales at commercial prices to physicians who are treating patients with limited therapeutic options in the second quarter of 2015. The EAP provides physicians with access to products in later stage development demonstrating evidence of clinical benefit, with an acceptable safety profile and a quality manufacturing process in place.
About Celsion Corporation
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. The pipeline also includes EGEN-001, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. Celsion has three platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies, including TheraPlas™, TheraSilence™ and RAST ™. For more information on Celsion, visit our website: http://www.celsion.com.
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; HEAT Study data is subject to further verification and review by the HEAT Study Data Management Committee; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses or the possible failure to make such acquisitions or licenses; 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.
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/celsion-announces-positive-interim-data-from-its-phase-2-dignity-study-in-breast-cancer-300066032.html
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LAWRENCEVILLE, N.J., April 15, 2015 /PRNewswire/ -- Celsion Corporation (CLSN) announced today positive interim data from its ongoing open-label Phase 2 DIGNITY Trial of ThermoDox® in recurrent chest wall (RCW) breast cancer. The trial is designed to enroll up to 20 patients at several U.S. clinical sites and is evaluating ThermoDox in combination with mild hyperthermia. Of the 16 patients enrolled and treated, 12 were eligible for evaluation of efficacy. Based on data available to date, 67% of patients experienced a clinical benefit of their highly refractory disease with a local response rate of 58% observed in the 12 evaluable patients, notably 5 complete responses (CR), 2 partial responses (PR) and 1 patient with stable disease (SD). The Company remains on track to complete enrollment in the study in the third quarter of 2015.
"The objective tumor response data including 5 complete responses emerging from the Phase 2 DIGNITY study are extremely impressive, particularly since the patients in the trial presented with highly resistant chest wall tumors that had progressed on multiple therapies, including chemotherapy, radiation and hormone therapy," noted Dr. Nicholas Borys, Celsion's Senior Vice President and Chief Medical Officer. "Together with the data from earlier Phase 1 studies, these interim results highlight the significant potential of ThermoDox® plus hyperthermia to stabilize disease in this difficult-to-treat patient population, and we look forward to bringing this trial to completion later this year."
These data are consistent with the previously reported Phase 1 data for ThermoDox® plus hyperthermia in RCW breast cancer, including combined clinical data from the Company's Phase 1 DIGNITY Study and a Duke University sponsored Phase 1 trial of ThermoDox®. The two similarly designed studies enrolled patients with highly resistant tumors found on the chest wall and who had progressed on previous therapies. There were 29 patients treated in the two trials, representing 11 patients in the DIGNITY study and 18 patients in the Duke study. Of the 29 patients treated, 23 were eligible for evaluation of efficacy. A local response rate of over 60% was reported in 14 of the 23 evaluable patients, with 5 complete responses and 9 partial responses.
"We are leveraging the remarkable data from our ThermoDox® program in RCW breast cancer to accelerate the development and commercialization of ThermoDox® in this indication in Europe," stated Michael H. Tardugno, Celsion's chairman, president and CEO. "The strength of the DIGNITY data is driving investigator interest in Europe and forming the basis for our Euro-DIGNITY trial, which is set to begin later this quarter. In addition, we are committed to providing patients who are suffering from this aggressive form of breast cancer with access to ThermoDox®, and continue to work closely with myTomorrows to launch an Early Access Program in Europe for ThermoDox® in RCW breast cancer."
The Euro-DIGNITY trial will evaluate ThermoDox® plus hyperthermia in RCW breast cancer patients and is designed to support a registration filing in Europe. This study will be conducted in five countries with the support of key European investigators and with assistance from MedLogics Corporation, an Italian-based hyperthermia device company. In addition, Celsion has a license and distribution agreement with myTomorrows to implement an Early Access Program (EAP) for ThermoDox® in all countries of the European Union territory plus Switzerland for the treatment of patients with RCW breast cancer. The Company expects to have ThermoDox® available for sales at commercial prices to physicians who are treating patients with limited therapeutic options in the second quarter of 2015. The EAP provides physicians with access to products in later stage development demonstrating evidence of clinical benefit, with an acceptable safety profile and a quality manufacturing process in place.
About Celsion Corporation
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. The pipeline also includes EGEN-001, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. Celsion has three platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies, including TheraPlas™, TheraSilence™ and RAST ™. For more information on Celsion, visit our website: http://www.celsion.com.
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; HEAT Study data is subject to further verification and review by the HEAT Study Data Management Committee; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses or the possible failure to make such acquisitions or licenses; 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.
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/celsion-announces-positive-interim-data-from-its-phase-2-dignity-study-in-breast-cancer-300066032.html
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