The Latest in FDA Evaluations and Research

FDA News

Related Topics: FDA News

News Feed Item

Celsion Reports Consolidated Duke University and Celsion's DIGNITY Study Clinical Data on ThermoDox® in Recurrent Chest Wall Breast Cancer Published in the International Journal of Hyperthermia

ThermoDox® Combined with Mild Local Hyperthermia is Safe and Produces Compelling Objective Local Responses in RCW Breast Cancer Patients

LAWRENCEVILLE, N.J., Sept. 4, 2014 /PRNewswire/ -- September 4, 2014 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) today announced that data from two Phase I studies on ThermoDox® in recurrent chest wall breast cancer were published in the International Journal of Hyperthermia. The article, titled "Two phase 1 dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer," appears in the  August 2014 issue (Volume 30, Number 5) and can be accessed here.

"Data from the two Phase I studies published in this peer-reviewed journal demonstrate that in heavily pretreated patients with unresectable recurrent chest wall breast cancer (RCWBC), treatment with 50 mg/m² of ThermoDox® combined with mild local hyperthermia is safe and produces objective responses in heavily pretreated RCWBC patients, a particularly difficult-to-treat patient population," said Mark Dewhirst, DVM, Ph.D., Vice Director for Basic Science, Duke Cancer Institute, Gustavo S. Montana Professor of Radiation Oncology in the School of Medicine, Professor of Pathology, Duke School of Medicine.

Nicholas Borys, M.D., Senior Vice President and Chief Medical Officer of Celsion, added, "We believe that the results of the Phase I studies reported in the journal are both consistent and compelling.  This adds to Celsion's recent interim data reported from our ongoing Phase II DIGNITY trial of ThermoDox® in recurrent chest wall recurrent breast cancer, which further supports our belief that continued development of ThermoDox® in patients with RCWBC is important. We look forward to continuing to advance our ThermoDox® clinical development program in a variety of cancers, particularly primary liver cancer, early stage breast cancer, colorectal liver metastases, pancreatic cancer and metastatic liver cancer."

The article describes the combined results of the two similarly designed Phase I trials with one study conducted at Duke University and the second study conducted at other major breast cancer centers in the U.S., in which eligible patients with unresectable chest wall recurrences had progressed on the chest wall after prior hormone therapy, chemotherapy, and radiotherapy. Patients received up to six cycles of ThermoDox® every 21-35 days, followed immediately by chest wall mild local hyperthermia for 1 hour at 40-42°C. In the first trial, 18 subjects received ThermoDox® at 20, 30, or 40 mg/m²; in the second trial, 11 subjects received ThermoDox® at 40 or 50 mg/m². The results showed that the maximum tolerated dose was 50 mg/m². The rate of overall local response was 48%, with five patients (17%) achieving complete local responses and nine patients (31%) having partial local responses. It was concluded that ThermoDox® at 50 mg/m² and mild local hyperthermia was safe, and this combined therapy produces objective responses in heavily pretreated RCWBC patients.

Importantly, these Phase I data are consistent with the impressive interim results from Celsion's ongoing open-label Phase II DIGNITY Study of ThermoDox® in RCWBC.  The DIGNITY Study will enroll a minimum of 20 patients at several U.S. clinical sites and is evaluating ThermoDox® in combination with mild hyperthermia using a treatment design equivalent to that used in the Phase I programs. Of the 13 patients enrolled and treated, 10 were eligible for evaluation of efficacy.  Based on data available to date, 60% of patients experienced a stabilization of their highly refractory disease with a local response rate of 50% observed in the 10 evaluable patients, notably 3 complete responses (CR), 2 partial responses (PR) and 1 patient with stable disease (SD). 

About Celsion Corporation

Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer. The pipeline also includes EGEN-001, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers.  Celsion has three platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies, including TheraPlas™ and TheraSilence™.  For more information on Celsion, visit our website:

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; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses or the possible failure to make such acquisitions or licenses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion's periodic reports and prospectuses filed with the Securities and Exchange Commission.  Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
[email protected]

SOURCE Celsion Corporation

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.