COLUMBIA, Md., Feb. 22 /PRNewswire-FirstCall/ -- Celsion Corporation today announced that a proposal entitled “Application of MRI-guided HIFU to Improve Cancer Chemotherapy with Temperature-Sensitive Targeted Nanomedicines (HIFU-CHEM)” submitted to the Center for Translational Molecular Medicine (CTMM) has been approved for funding. This project, lead by University Medical Center Utrecht in the Netherlands will bring together several MRI-guided HIFU academic and industrial technological teams specializing in nanotechnologies as well as clinical applications. The team is comprised of members from University Medical Center Utrecht, Celsion, Philips Healthcare, Utrecht University, and Technical University Eindhoven and the National Institutes of Health’s Clinical Center. The project has a 6.4 million Euro budget, which is planned to commence in May 2010, and will fund 48 months of research and development costs supporting thermally sensitive liposomes, including ThermoDox® in combination with MR-HIFU (Magnetic Resonance guided High Intensity Focused Ultrasound) as a therapy to non-invasively treat both liver tumors and secondary bone tumors.
Philips’ MR-HIFU system has the potential to precisely and non-invasively target lesions with acoustic energy, creating sufficient heat to activate ThermoDox® and preferentially release high concentrations of the drug doxorubicin. This combination treatment approach may change the paradigm for addressing a broad range of cancers.
Prominent experts in the field of MR-HIFU cancer treatment include, Dr. Gert Storm of Utrecht University, Drs. Chrit Moonen and Willem Mali of University Medical Center Utrecht, Dr. Holger Gruell of Technical University Eindhoven, and Dr. Bradford Wood of the National Institutes of Health Clinical Center, who are participating in the consortium. These researchers will be conducting pre-clinical studies to assess doxorubicin drug delivery and to optimize MR-HIFU performance in this application. An Investigational New Drug submission is planned for 2010, following successful completion of the pre-clinical studies.
“The drug/device combination of ThermoDox and MR-HIFU acts synergistically with the potential to provide an innovative non-invasive therapy for patients with aggressive and life-threatening cancers,” said Nicholas Borys, MD, Celsion’s Vice President and Chief Medical Officer.
“Since the beginning of our collaboration with Philips in 2008, we have made excellent progress to develop ThermoDox and MR-HIFU as a potential for a new paradigm for treating local and advanced cancers,” added Michael H. Tardugno, Celsion’s President and Chief Executive Officer. “Initial feasibility work suggests that the combination of these technologies has the potential to significantly expand the market for ThermoDox. We are highly encouraged that the work and commitment of our research and medical partners will provide the promise of our platform technology to thousands of patients with difficult to treat diseases.”
Investor Contact
Marcy Nanus The Trout Group 646-378-2927 mnanus@troutgroup.com
About ThermoDox®
ThermoDox in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
For primary liver cancer, ThermoDox is being evaluated in a 600-patient global Phase III study at 70 clinical sites under an FDA Special Protocol Assessment. The primary endpoint for the study is progression-free survival and enrollment is expected to be completed in 2010. For recurrent chest wall breast cancer, ThermoDox is being evaluated in a Phase I/II open-label, dose escalating trial that is designed to measure durable local complete response at the tumor site. Celsion expects to enroll approximately 100 patients across the United States and to complete the study by the first half of 2010. Additional information on these ThermoDox clinical studies may be found at http://www.clinicaltrials.gov.
ThermoDox® is a registered trademark of Celsion Corporation
About Celsion Corporation
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heatactivated drug delivery systems. Celsion has licensed ThermoDox(R) to Yakult-Honsha for the Japanese market and has a partnership agreement with Philips Healthcare to jointly develop its heat activated liposomal technology in combination with high intensity focused ultrasound to treat difficult cancers. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System. 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 by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company’s periodic reports filed with the Securities and Exchange Commission.
Disclaimer:
No endorsement of any organization, product or service mentioned here is intended by the National Institutes of Health or its employees or should be inferred.
