Tumor Targeting Docetaxel Abstract Selected for Presentation at the 11th Liposome Research Days Conference
The presentation will provide detailed preclinical results regarding the use of Celsion's temperature sensitive liposome formulation with docetaxel. This novel encapsulation of a well known chemotherapeutic agent demonstrates improved anti-tumor effect in-vivo. Mice were tumored with a Lewis lung cell line in the leg and then treated in three cohorts: with free docetaxel; docetaxel encapsulated in non-temperature sensitive liposomes; or with Celsion's proprietary temperature sensitive liposomes containing docetaxel. Each of the three cohorts was treated by intravenous injection every other day followed by the application of heat to the tumored leg. After treatment the tumor volumes were followed for two weeks. Results indicated that the reduction in tumor volume generated by the heat activated liposomal formulation was statistically superior to both the free docetaxel and the non-temperature sensitive liposomal formulation.
Docetaxel is a well established cancer chemotherapy approved by the Food and Drug Administration to be used alone or with other drugs to treat certain types of breast and non-small cell lung cancer. It is also approved to be used with other drugs to treat squamous cell carcinoma of the head and neck and certain types of gastric and prostate cancer. Docetaxel is marketed worldwide under the name Taxotere(R).
Mr. Michael Tardugno, Celsion's President and Chief Executive Officer, commented, "Acceptance of our abstract for presentation at this prestigious conference reinforces our belief in the promise of our technology and the interest of the scientific and medical community in Celsion's elegant, tumor targeting, liposomal technology. The unpublished data from these studies is strongly suggestive of the platform capability of our heat sensitive liposomal technology, and provides the basis for continued development of our novel, four lipid formulation of liposomal Docetaxel. Our objective this year is to replicate these results in a variety of xenograft human tumor models and to initiate toxicological studies.
"Following successful results, Celsion will then finalize a clinical development strategy and devise a regulatory pathway with the FDA. We will continue to build a pipeline of chemotherapeutic drugs, extending our reach into the treatment of additional cancer indications where patients have unmet medical needs.
"In the meantime we remain focused on and are committed to delivering timely clinical results and regulatory approval for our first drug in development, ThermoDox(R), which is currently in a Phase III study for the treatment of primary liver cancer. In addition, immediately following the conclusion of our Phase I study at Duke University Medical Center for the treatment of patients with recurrent breast cancer at the chest wall, we would anticipate the start of our pivotal Phase II study. Our target to initiate this study is the 4th quarter 2008", Mr. Tardugno concluded.
About ThermoDox(R): ThermoDox(R) is Celsion's proprietary heat-sensitive liposomal encapsulation of doxorubicin, an approved and frequently used anti-cancer drug used in the treatment of various cancers. Localized heat (at 40-42 degrees Celsius and above) 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: Celsion is dedicated to the development and commercialization of oncology 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, Cleveland Clinic, North Shore Long Island Jewish Health System. (CLN-W)
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.
Paul G. Henning, 212-554-5462
Posted: June 2008