Celsion Announces Oral Presentation of Phase I ThermoDox Data At 2010 IHPBA World Congress
Study Results Presented at Liver Tumors Panel by Investigator Dr. Thanjavur S. Ravikumar
COLUMBIA, Md., April 20 /PRNewswire-FirstCall/ -- Celsion
Corporation (NASDAQ:CLSN) today announced that Dr. Thanjavur
S. Ravikumar, from the Geisinger Health System and a principal
investigator of the Phase I ThermoDox® dose escalation trial,
gave an oral presentation at the Liver Tumors Panel session of the
9th World Congress of the International Hepato-Pancreato-Biliary
Association (IHPBA) in Buenos Aires, Argentina. The presentation,
titled "A Phase I Trial of ThermoDox® in Patients Undergoing
Radiofrequency Ablation (RFA) of Liver Tumors," provided a summary
of the data as well as illustrative patient case studies. The trial
results not only support the use of ThermoDox® plus RFA for the
treatment of primary liver cancer, but also provide supportive
evidence for Celsion to evaluate the effects of ThermoDox in
patients with colorectal liver metastases (CRLM).
"Eight out of the twelve patients we treated in this study had
CRLM, some of whom had as many as nine lesions with multi-focal
disease," said Dr. Ravikumar. "ThermoDox is a unique therapy that
is showing great promise in treating this very aggressive disease.
I look forward to providing long-term follow-up and a publication
at a future date."
"CRLM is a major problem in the western hemisphere, just as
primary liver cancer is in Asia Pacific," remarked Michael H.
Tardugno, President & Chief Executive Officer of Celsion
Corporation. "We look forward to bringing ThermoDox to the market
in the US, which will help address an estimated 300,000 cases of
liver metastases, almost half of which come from colorectal
cancer."
Celsion previously announced its plans to conduct a randomized
Phase II CRLM study to further evaluate the efficacy of ThermoDox
plus RFA. This trial will be initiated later this year following
the completion of enrollment in Celsion's pivotal Phase III HEAT
trial for primary liver cancer trial. "Local control in patients
with liver metastasis is of interest to the medical community,"
noted Nicholas Borys, Celsion's Vice President and Chief Medical
Officer. "This study adds to the growing body of scientific data
that ThermoDox may play an important role as an adjunct to liver
tumor ablation."
Dr. Ravikumar's oral presentation is available on Celsion's
website at www.celsion.com/events.cfm.
About Colorectal Liver Metastases (CRLM)
The American Cancer Society estimates that there were about
147,000 new cases of colorectal cancer and about 50,000 colorectal
cancer deaths during 2009. Up to 25% of patients with colorectal
cancer present with liver metastases and another 50% develop liver
metastases within 5 years. Median survival of patients with
colorectal liver metastases (CRLM) is 6-12 months if untreated.
While hepatic resection is potentially curative, most CRLM patients
are inoperable and therefore radiofrequency ablation (RFA) is the
most frequently used local treatment modality for CRLM. Because RFA
is both efficacious and widely accepted, a rational strategy is to
attempt to increase its efficacy for medium (3.1-5.0 cm) and large
(> 5.0 cm) CRLM tumors with an adjuvant such as ThermoDox.
About ThermoDox®
ThermoDox in combination with hyperthermia or ablation has the
potential to provide local tumor control, extending and improving
the quality of life. 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 and liver cancer. Localized mild
hyperthermia (40-42 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 already demonstrated remarkable evidence of
clinical activity in Phase I studies for primary liver cancer and
recurrent chest wall breast cancer. For the primary liver cancer
indication, Celsion has been granted FDA Orphan Drug designation.
For recurrent chest wall breast cancer, ThermoDox® is being
evaluated in a pivotal Phase I/II open-label, dose-escalating trial
that is designed to measure durable local complete response at the
tumor site.
ThermoDox® is a registered trademark of Celsion Corporation About ThermoDox Global Phase III HEAT Study
Celsion's global ThermoDox Phase III study for HCC, the most
common form of primary liver cancer, is being conducted under a
Special Protocol Assessment with the U.S. Food and Drug
Administration (FDA). The 600 patient study, currently being
conducted in 73 clinical trial sites in 11 countries, is designed
to evaluate the efficacy of ThermoDox in combination with RFA when
compared to patients who receive RFA alone as the control. The
primary endpoint is progression free survival with a secondary
confirmatory endpoint of overall survival. A pre-planned,
un-blinded interim efficacy analysis will be performed by an
independent Data Management Committee when 50% of the progression
free survival endpoint events are realized in the study population.
Based on an historical review of RFA cases, Celsion expects the
study could be completed by the middle of 2011, and pending
positive data, a New Drug Application would be submitted to the FDA
before the end of 2011. Additional information on the ThermoDox
Phase III clinical study may be found at http://www.clinicaltrials.gov/.
About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer
and ranks as the fifth most common solid tumor cancer, with
Hepatocellular Carcinoma (HCC) as the most commonly known form of
HCC. The incidence of primary liver cancer is approximately 20,000
cases per year in the United States and is rapidly growing
worldwide at approximately over 660,000 cases per year, due to the
high prevalence of Hepatitis B and C in developing countries. Among
the standard treatment options for liver cancer is surgical
resection of the tumor; however 70% to 80% of patients are
ineligible for surgery. Radio frequency ablation (RFA) has
increasingly become the standard of care for non-resectable liver
tumors, but the treatment becomes less effective for larger
tumors.
About 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 Philips Healthcare 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 world-wide such as the National Institutes of Health,
Duke University Medical Center, the University of Hong Kong, and
the Cleveland Clinic. 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.
Investor Contact Marcy Nanus The Trout Group 646-378-2927 mnanus@troutgroup.com
Source: Celsion Corporation
CONTACT: Marcy Nanus, The Trout Group, +1-646-378-2927,
mnanus@troutgroup.com
Web Site: http://www.celsion.com/
Posted: April 2010
