Celsion Announces Collaboration with the Children’s Research Institute to Evaluate the Use of ThermoDox® and High Intensity Focused Ultrasound in the Treatment of Solid Tumors in Children and Young Adults

First Ever Clinical Trial in Children Using a Targeted Chemotherapeutic Drug Released by Focused Ultrasound Expected to Commence in Q4 2016 

Initiation of this NIH-funded Study follows the Recent Announcement of NIH’s Finding That Thermal Dose Appears to Improve Overall Survival in Primary Liver Cancer Patients Treated with ThermoDox®

LAWRENCEVILLE, N.J., Oct. 11, 2016 (GLOBE NEWSWIRE) — Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company, today announced a collaboration with the Children’s Research Institute to conduct a clinical study of ThermoDox®, Celsion’s heat activated liposomal encapsulation of doxorubicin, in combination with magnetic resonance-guided high intensity focused ultrasound (MR-HIFU) to treat relapsed or refractory solid tumors in children and young adults.  This investigator-sponsored Phase I clinical study is being partially funded by the National Institutes of Health and is expected to commence in the fourth quarter of 2016. 

“Even with the use of intensive therapy, the prognosis for children diagnosed with metastatic sarcoma and recurrent solid tumors remains poor and has not improved over the past three decades,” stated Dr. Nicolas Borys, Celsion’s chief medical officer.  “Recent advances in the use of non-invasive MR-HIFU coupled with novel therapies such as ThermoDox® have demonstrated the clear potential to overcome the challenges to treating pediatric malignancies by enabling safer, more tolerable targeted therapies with the potential to change cancer treatment paradigms.” 

The trial targeting treatment of childhood sarcomas will be carried out as a multi-disciplinary collaboration among Celsion, the research groups of Dr. AeRang Kim, MD, PhD at the Children’s National Medical Center – Department of Hematology/Oncology, and Dr. Brad Wood and Dr. Rosandra Kaplan at the National Institutes of Health.

“Celsion’s experience in combining ThermoDox® with HIFU, a non-invasive next generation heating technology, supports this very important research in childhood cancers.  From a safe dose, ThermoDox’s proven ability to deliver high concentrations of an effective chemotherapy directly to a heated tumor makes it an ideal candidate for a trial involving children and young adults,” said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer.  “This study will further define ThermoDox’s potential in combination with ultrasound-induced hyperthermia, and highlight potential applications of ThermoDox® in combination with a broad range of heating technologies that could address an even larger population of patients.”

ThermoDox® is currently in late stage clinical trials in primary liver cancer and recurrent chest wall breast cancer. It is positioned for use with multiple heating technologies, and has the potential for applications in the treatment of other forms of cancer including metastatic liver and non-muscle invading bladder cancers.  

About ThermoDox®

Celsion’s most advanced program is a heat-mediated, tumor-targeting drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox® has the potential to address a broad range of cancers.

Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism, rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, ThermoDox® is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream.  In the second mechanism, when an external heating device heats tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and into the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area related to tumor invasion, supporting more precise drug targeting.

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 and in Phase II development for the treatment of recurrent chest wall breast cancer. The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anticancer DNA or RNA therapies, including TheraPlas™ and TheraSilence™. The Company has a Cooperative Research and Development Agreement (CRADA) with the NIH.  Any reference to NIH should not be viewed as an endorsement of Celsion, its products or services.

For more information on Celsion, visit our website: http://www.celsion.com. (LTSL/ThermoDox®)

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 Celsion’s periodic reports and prospectuses filed with the Securities and Exchange Commission.  Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

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