Celsion Presents ThermoDox® Clinical Data at the 2010 Breast Cancer Symposium
Clinical Safety and Efficacy results presented for 40mg/m2 completed dose cohort of Phase I/II Recurrent Chest Wall Breast Cancer study
Higher dose cohort reaches enrollment completion
COLUMBIA, Md., Oct. 1 /PRNewswire/ -- Celsion Corporation (Nasdaq: CLSN) announced today that interim data from its Phase I/II DIGNITY trial of ThermoDox® in Recurrent Chest Wall (RCW) Breast Cancer were presented at the poster session at the 2010 Breast Cancer Symposium. The abstract provided updated clinical results from the 40 mg/m2 dose cohort. Additionally the company announced that the 50 mg/m2 dose cohort has now completed enrollment. This DIGNITY study evaluates ThermoDox in combination with microwave hyperthermia in women with RCW Breast Cancer. The poster session was held October 1, 2010 at the Gaylord National Hotel in Suburban Washington, DC.
The abstract, titled "Phase I/II study evaluating the maximum tolerated dose, pharmacokinetics, safety, and efficacy of hyperthermia and lyso-thermosensitive liposomal doxorubicin in patients with breast cancer recurrence at the chest wall," is authored by Brigid O'Connor, M.D., Ph.D., lead clinical investigator from the Rhode Island Hospital in Providence, RI.
Dr. Nicholas Borys, Chief Medical Officer at Celsion Corporation commented, "We continue to see clinical activity in our patients, with a satisfactory safety profile. Patients at the 40 mg/m2 dose demonstrated encouraging results. Recently, the DIGNITY Drug Safety Monitoring Board (DSMB) allowed for dose escalation to the 50 mg/m2 cohort. We are awaiting the DSMB to reconvene after this higher dose cohort completes follow-up in the fourth quarter of 2010. Upon DSMB review, we will develop plans on how best to proceed with the study."
"This positive clinical data along with increased enrollment provides momentum to our RCW trial," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Outreach to the ASCO community will help increase awareness that the DIGNITY Study can be an important option for this underserved patient population and increase participation."
Principal investigator Dr. O'Connor commented, "Although treatment using heat sensitive liposomal doxorubicin with microwave hyperthermia (heat) is investigational at this time, we are encouraged that this approach may provide a promising outcome for breast cancer patients with painful loco-regional recurrence on the chest wall. Rapid evaluation of ThermoDox is warranted as we search for ways to provide patients with better treatment options 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 108 patients into Phase II. The results from the DIGNITY trial are expected to build on the promising data from the Phase I dose escalation study conducted at Duke University Medical Center.
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®, which 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: www.clinicaltrials.gov.
ThermoDox® is a registered trademark of Celsion Corporation.
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 the Company's 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: 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.
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