June 22, 2011

Celsion's ThermoDox(R) Featured in Special Issue of The Open Nanomedicine Journal

COLUMBIA, MD -- (MARKET WIRE) -- 06/22/11 -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that ThermoDox®, its proprietary, heat-activated liposomal encapsulation of doxorubicin, was featured in a special issue of The Open Nanomedicine Journal (2011, volume 3) highlighting recent advances, trends and challenges in the use of regional and local hyperthermia and nanomedicine in oncology. In an article titled "Nanoscale Drug Delivery and Hyperthermia: The Materials Design and Preclinical and Clinical Testing of Low Temperature-Sensitive Liposomes Used in Combination with Mild Hyperthermia in the Treatment of Local Cancer," a research team led by Mark W. Dewhirst, DVM, PhD, Gustavo S. Montana Professor of Radiation Oncology and Professor of Pathology and Biomedical Engineering at the Duke University Medical Center, provides a comprehensive review of the design, mechanisms, preclinical data, clinical data, challenges and applications of Low Temperature-Sensitive Liposomes (LTSL), the technology behind ThermoDox®, as well as other liposomal therapies. Chelsea D. Landon, Ji-Young Park, PhD, David Needham, PhD, of Duke University, co-authored the article, which is available online.

"To retain drug, evade the body's defenses, and accumulate in tumors, as with traditional liposomal chemotherapeutics, is not enough to deliver bioavailable drug to tumors. The ideal drug delivery vehicle should also possess a trigger allowing for the rapid and complete release of free drug within the tumor tissue, which is exactly what the Low Temperature-Sensitive Liposome provides," commented Dr. Dewhirst. "LTSL, which initiates local drug release using mild hyperthermia, has shown dramatic results in preclinical studies and is currently undergoing phase III clinical trials. If these liposomes prove to be as effective in humans as in preclinical settings, a push for their broad use in the treatment of human disease should be made."

The article describes a number of advantages of LTSL over traditional chemotherapies and liposomal technologies, including:

  • Drug delivery to the tumor at concentrations up to 30 times greater than those achievable with free drug and 3-5 times greater than those of traditional liposomes, while maintaining the toxicity benefits of sequestering drug;
  • The ability to achieve the high intravascular drug concentrations necessary for driving cellular drug uptake and increasing drug penetration further from vessels, overcoming the obstacles of limited penetration associated with traditional liposomal technologies; and
  • Activation at mild hyperthermia, a temperature which increases blood flow and tumor permeability, and is readily achievable in superficial and deep-seated tumors.

The article also provides a review of preclinical and clinical studies that have demonstrated the enhanced effects or potential of combining hyperthermia and ThermoDox® in oncology. Among the studies noted are Celsion's pivotal Phase III study in primary liver cancer (the HEAT study), its ongoing, potentially registrational Phase I/II study in recurrent chest wall breast cancer (the DIGNITY study) and a planned clinical trial assessing the use of ThermoDox® and Philips Healthcare's high-intensity focused ultrasound (HIFU) technology in metastatic bone cancer patients.

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 including breast cancer. ThermoDox® is administered intravenously and in combination with hyperthermia. Localized mild hyperthermia (39.5-42 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 76 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with Radio Frequency Ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the HEAT Study is complete and 190 PFS events are realized in the study population.

For recurrent chest wall breast cancer, ThermoDox® is being evaluated in a pivotal Phase I/II open-label, dose-escalating trial that is designed to measure durable local complete response at the tumor site. Additional information on the Company's ThermoDox® clinical studies may be found at www.clinicaltrials.gov.

About Celsion Corporation

Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. 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, the University of Pisa, and the North Shore Long Island Jewish Health System.

For more information on Celsion, visit our website: http://www.celsion.com.

Special Note: Dr. Dewhirst has provided consulting services for Celsion and holds stock options in the Company. Dr. Needham is the inventor of the thermally sensitive liposome technology which Celsion has exclusively licensed from Duke University. Dr. Needham also holds stock and stock options in Celsion.

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.

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