Celsion Corporation Announces $1 Million NIH, NIBIB - Career Development Award Grant for Glioblastoma Research with ThermoDox® and HIFU

LAWRENCEVILLE, N.J., July 21, 2014 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today that its ongoing collaboration with Dr. Costas Arvanitis of Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School, has been expanded through the recent award of a $1 million Career Development Award from the National Institutes of Health's Center for Biomedical Imaging and Bioengineering (NIBIB). The grant will support preclinical studies evaluating ThermoDox®, the Company's heat-activated liposomal encapsulation of doxorubicin, in combination with High Intensity Focused Ultrasound (HIFU), for the treatment of brain tumors.  The grant, titled "Controlled Delivery and Release of Chemotherapy in Brain Tumors with FUS" provides on average of $200,000 in annual funding for five years, and will be used to advance preclinical development of ThermoDox® for the treatment of brain cancers, including GBM, under the Company's January 2014 collaboration with Brigham and Women's Hospital, Harvard Medical School.

"This peer-reviewed grant award builds upon our ongoing collaborative work to explore treatments for brain tumors," said Costas D. Arvanitis, Ph.D., Brigham and Women's Hospital, Harvard Medical School. "Delivering chemotherapeutic agents across the blood-brain barrier is particularly challenging, but in recent years we have discovered that this could be achieved using focused ultrasound, including enhanced delivery of liposomal doxorubicin.  We are hopeful that this grant will allow us to determine the potential utility of a promising therapeutic application for one of the most insidious cancers - glioblastoma."

"Glioblastoma is a highly aggressive and deadly form of brain cancer for which there are few treatment options," said Michael H. Tardugno, Celsion's President and CEO.  "Working with a prominent cancer research group like Dr. Arvanitis and his team, combined with the financial support of the NIH, will help accelerate the research required to elucidate the potential of ThermoDox® combined with HIFU in this difficult to treat cancer, and provide a path forward for larger, more comprehensive Phase II studies."

If promising results are obtained from these Phase I studies, a Phase II grant application will be submitted to include more comprehensive studies of ThermoDox® and HIFU for the treatment of GBM brain tumors.

About Glioblastoma Multiforme (GBM) Brain Tumors

Glioblastoma multiforme (GBM), WHO classification name "glioblastoma", is the most common and most aggressive malignant primary brain tumor in humans, involving glial cells and accounting for over 50% of all functional tissue brain tumor cases and nearly 20% of all intracranial tumors.  In 2013, projected US incidence of brain tumors approaches 23,000 cases, with projected mortality at 14,000 cases. Treatment can involve chemotherapy, radiation and surgery. Median survival with standard-of-care radiation and chemotherapy is normally 15 months, and median survival without treatment is approximately 4½ months.

About ThermoDox®

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.  ThermoDox® is being evaluated in a Phase III clinical trial for primary liver cancer and a Phase II clinical trial for recurrent chest wall breast cancer.  Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by radiofrequency ablation (RFA) releases the entrapped doxorubicin from the liposome.  This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

About Celsion Corporation

Celsion is 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^TM, TheraSilence^TM and RAST^TM.  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, including, without limitation, statements about the acquisition and the combined company as well as clinical and pre-clinical programs, involve risks and uncertainties. These risks and uncertainties include, without limitation, difficulties and operational and financial risks associated with integrating Celsion and EGEN after completion of the acquisition; unforeseen changes in the course of research and development activities and in clinical trials; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; termination of the Technology Development Contract or collaboration between Celsion and Hisun at any time; possible changes in cost and timing of development and testing, capital structure, financial condition, working capital needs and other financial items; 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 filed with the Securities and Exchange Commission, including its Form 10-Q filed on May 8, 2014. 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
[email protected]

SOURCE Celsion Corporation