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COLUMBIA, Md., Aug 17, 2009 (BUSINESS WIRE) -- Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company, today announced that the FDA has provided the Company with positive guidance at a Type C Chemistry Manufacturing and Controls ("CMC") meeting recently held at the FDA's Office of New Drug Quality Assessment.
The FDA has provided the Company with the oral and written guidance that permits Celsion to implement and validate process improvements to the manufacturing methods used to produce ThermoDox(R), the Company's lead product in a global Phase III clinical study for primary liver cancer. Based on FDA's guidance, the Company intends to move forward with its plans to scale up the ThermoDox manufacturing process so that larger, more economical batches can be manufactured at quality levels that support commercial launch plans.
"FDA's guidance and continued willingness to collaborate with Celsion is very much appreciated, " stated Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Our close consultation with the FDA's CMC group from the start of ThermoDox's development has allowed us to successfully mitigate the risks common to CMC programs. We now have well defined clinical, regulatory and manufacturing pathways to commercialization and are pleased to be taking the proper steps to ensure manufacturing capacity is in place to support product launch."
Celsion's global Phase III Primary Liver cancer study of ThermoDox in combination with radiofrequency ablation is being conducted in agreement with FDA under Special Protocol Assessment guidance. The Company expects patient enrollment to be complete in the spring of 2010. Celsion is conducting a second registrational trial to evaluate ThermoDox in combination with hyperthermia to treat recurrent chest wall cancer. ThermoDox incorporates a unique heat sensitive liposomal formulation of doxorubicin and has shown remarkable evidence of clinical activity in early stage clinical trials. The market potential for ThermoDox is well in excess of $1 billion.
About ThermoDox
ThermoDox(R) in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox(R) 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 (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(R) is being evaluated in a 600 patient global Phase III study under an agreement with FDA for Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox(R) in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival. For recurrent chest wall breast cancer, ThermoDox(R) 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. Celsion expects to enroll approximately 100 patients across the United States. Additional information on these ThermoDox(R) clinical studies may be found at http://www.clinicaltrials.gov
ThermoDox(R) is a registered trademark of Celsion Corporation
About Celsion
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has licensed ThermoDox(R) to Yakult-Honsha for the Japanese market and has a partnership agreement with Phillips Medical 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.
SOURCE: Celsion Corporation
Celsion Corporation
Sean Moran, 410-290-5390
Senior Vice President and Chief Financial Officer
smoran@celsion.com
or
The Trout Group
Marcy Nanus, 646-378-2927
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