July 29, 2008
Tumor Targeting Docetaxel Abstract Presented at the 11th Liposome Research Days Conference
CELSION CORPORATION (NASDAQ: CLSN) announced that its docetaxel thermosensitive liposome preclinical study results were presented at the 11th Liposome Research Days Conference during the poster session on July 22, 2008.
The well attended presentation provided detailed preclinical results regarding the use of Celsion's temperature sensitive liposome formulation with docetaxel. This novel, patent pending encapsulation of a well known chemotherapeutic agent demonstrates improved anti-tumor effect in-vivo. In the presented study, mice were tumored with a Lewis lung cell line in the leg and then treated in three cohorts: with free docetaxel only; 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 monitored 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.
The presentation also included results demonstrating superior drug concentration associated with the docetaxel thermosensitive liposome to be over two times that of free docetaxel in the targeted tissue. Gross measures of toxicity were suggestive of the docetaxel thermosensitive liposome potential for an improved safety profile in this animal model. Copies of the Abstract and Poster can be found on the Company's web-site at www.Celsion.com.
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, "Celsion's elegant; tumor targeting, liposomal technology continues to demonstrate its significant potential. The high degree of statistical significance of these studies supports our confidence in the novel formulation and its further development. Additionally, the unpublished data from these studies is strongly suggestive of the platform capability of our heat sensitive liposomal technology and its potential to support a pipeline of future chemotherapeutics. Our objective this year is to replicate these results in a variety of xenograft human tumor models and to initiate toxicological studies. Celsion will finalize a clinical development strategy and devise a regulatory pathway with the FDA following the successful outcome of these studies."
"We will continue to build a pipeline of effective compounds, extending our reach into the treatment 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, Celsion is planning our pivotal Phase II study for the treatment of Recurrent Breast Cancer at the Chest Wall. 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. (CLSN-W)
For more information on Celsion, visit our website: 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.