Bookmark and Share

Celsion Corp. (CLSN) Announces ThermoDox(R) Abstract Accepted for Presentation

Press Release Source: Celsion Corporation On Thursday March 18, 2010, 7:30 am EDT

COLUMBIA, Md., March 18 /PRNewswire-FirstCall/ — Celsion Corporation (Nasdaq:CLSNNews) today announced that an abstract about the Phase I/II trial of ThermoDox® in Recurrent Chest Wall Cancer (RCW) has been accepted for presentation at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting.  The abstract presents the background, rationale, and design of the DIGNITY study which is ongoing and evaluating ThermoDox in combination with hyperthermia in women with recurrent breast cancer on their chest wall.  The ASCO Annual Meeting will be held June 4 – 8, 2010 at the McCormick Place Convention Center in Chicago, Illinois.

The abstract, titled “Phase I/II study evaluating the maximum tolerated dose, pharmacokinetics, safety, and efficacy of approved hyperthermia and lyso-thermosensitive liposomal doxorubicin in patients with breast cancer recurrence at the chest wall” will be presented by Nicholas Borys, M.D., Celsion’s Chief Medical Officer.

“We are pleased that our study was among those that were accepted providing continued evidence of the medical community’s high interest level in ThermoDox, the progress of our clinical program, and our focus on a cancer that is very difficult to treat,” commented Michael H. Tardugno, Celsion’s President and Chief Executive Officer.  “We are grateful for the commitment of our clinical investigators to this important work and look forward to their on-going participation in the DIGNITY trial.”

Dr. Borys commented, “Our Phase I/II trial combines ThermoDox with hyperthermia, offering a unique approach to treating patients with difficult loco-regional recurrence of breast cancer at the chest wall. In a separate trial of similar design being conducted at Duke University Medical Center, researchers are reporting convincing evidence of clinical activity.  I look forward to the continuation of our trial and the potential to provide an improvement in the standard of care for this devastating disease.”

About the DIGNITY Clinical Trial

The DIGNITY clinical trial is a Phase I/II open label, dose escalating trial to evaluate the safety and efficacy of ThermoDox® with hyperthermia for the treatment of Recurrent Chest Wall (RCW) Breast Cancer, an aggressive form of cancer with a poor prognosis and limited treatment options. The primary endpoint in the DIGNITY trial is durable complete local response at the tumor site. Once the safe dose is determined Celsion intends to enroll up to 100 patients to establish efficacy. The results from the DIGNITY trial are expected to build on the promising data from the Phase I dose escalation study currently being conducted at Duke University Medical Center.

About ThermoDox(R)

ThermoDox® 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. ThermoDox® is administered intravenously and in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. 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.

ThermoDox® has also demonstrated evidence of efficacy in a Phase I study for primary liver cancer. Celsion has been granted FDA Orphan Drug designation for ThermoDox® and is conducting a pivotal 600 patient global Phase III study in primary liver cancer under a FDA Special Protocol Assessment.

Additional information on ThermoDox® clinical studies for RCW breast cancer and primary liver cancer can be found at:

ThermoDox® 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:

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.

Friday, March 19th, 2010 Uncategorized
Top Small Cap Market News