Liver Phase I Results Presented At WCIO 2008 & Best Of ASCO(R)

Main Category: Cancer / Oncology
Also Included In: Liver Disease / Hepatitis;  Clinical Trials / Drug Trials
Article Date: 30 Jun 2008 - 9:00 PDT

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Celsion Corporation (NASDAQ: CLN) announced that the interim results from its second Phase I liver cancer confirmation study of ThermoDox in combination with Radio Frequency Ablation (RFA) treating patients with primary and metastatic liver cancer were presented at both Oral and Poster presentation at the WCIO 2008 and Best of ASCO® conference. The presentation provided Phase I interim results including safety, dosing and pharmacokinetic summaries supporting the company's global pivotal trial in Hepatocellular Carcinoma, which is currently enrolling patients.

This annual WCIO (World Congress of Interventional Oncology) conference partnered with the Best of ASCO to present novel therapies in the emerging field of interventional oncology in a unique multidisciplinary meeting. This conference was held from June 22 - 25, 2008 at the Hyatt Regency Century Plaza in Los Angeles, CA. http://www.wcio2008.com/

The abstract presentation, titled "Phase I Dose Escalation Study of Thermally Sensitive Liposomal Doxorubicin (ThermoDox®) in combination with Radiofrequency Ablation (RFA) of Primary and Metastatic tumors to the liver: Interim Report" was delivered by Dr. Thanjavur S. Ravikumar, MD, Professor and Chairman, Department of Surgery, North Shore Hospital, Albert Einstein Medical School. Dr. Ravikumar commented, "These phase I findings are encouraging in terms of safety, drug distribution and cancer activity. I am pleased to observe impressive early responses in a variety of liver tumors." Local return of cancer was seen in only 2 of 44 tumors treated with RFA plus ThermoDox, resulting in an impressive 4.5% local recurrence rate. In addition, 5 of the 10 evaluable patients demonstrated a complete response (CR), along with a single partial response (PR). The progressive disease (PD) patients were largely a result of extra-hepatic or distal hepatic recurrence, both from not treated lesions. The majority of the patients were metastatic liver cancer patients, presenting with extrahepatic disease.

Additionally, Celsion's newly initiated phase III study of ThermoDox in patients with hepatocellular carcinoma (HEAT Study) was presented during the Clinical Trials Update Session. The presentation was given by HEAT European Lead Principal Investigator Dr. Riccardo Lencioni who reviewed the study objectives, design and patient criteria with the audience.

Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented, "The results presented by Dr. Ravikumar re-validate our proof of concept in liver cancer and further confirm our single vial formulation with which we plan to enter the market. The selection for Oral and Poster presentation demonstrates the medical interest in the unique role that ThermoDox can play in the treatment of liver cancer."

The WCIO 2008, Best of ASCO presentation was the fourth time this year that Phase I results from ThermoDox trials have been presented at a major medical conference. In February, Dr. Ronnie T. Poon, Professor of Surgery at the Queen Mary Hospital, Hong Kong, presented our Phase I liver study results at the IHBPA conference in Mumbai, India, at the Oral Paper Awards Session. In March, Dr. Bradford J. Wood's abstract titled "Imaging Features in Patients undergoing Liver RFA plus Heat Deployed Nanoparticles" was selected for Oral presentation at Society for Interventional Radiology. Also in March, Dr. Zeljko Vujaskovic, Associate Clinical Professor at Duke University, on behalf of Dr. Ellen Jones, presented interim progress and evidence of safety and suggested efficacy from our second indication under study, Recurrent Chest Wall breast cancer, at ICHO Conference in Munich, Germany.

Mr. Tardugno concluded, "It's clear that the excitement for our Phase III HCC trial announced by Dr. Lencioni is supported by the promise of clinical activity - as reported in Phase I studies - and is consistent with the potential for ThermoDox to provide an effective treatment for these two difficult-to-treat cancers."

About ThermoDox®

ThermoDox® 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.

Celsion

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