Company to Host Conference Call at 8:00 AM EST Today
LAWRENCEVILLE, N.J., Jan. 31, 2013 /PRNewswire/ — Celsion Corporation
(NASDAQ: CLSN), a leading oncology drug development company, today
announced that ThermoDox® in combination with radiofrequency ablation
(RFA) did not meet the primary endpoint of the Phase III HEAT Study in
patients with hepatocellular carcinoma (HCC), also known as primary
has determined, after conferring with its independent Data Monitoring
Committee (DMC) that the HEAT Study did not meet the goal of
demonstrating persuasive evidence of clinical effectiveness that could
form the basis for regulatory approval in the population chosen for
study. The HEAT Study was designed to show a 33% improvement in PFS
with 80% power and a p-value = 0.05. In the trial, ThermoDox® was
well-tolerated with no unexpected serious adverse events. The HEAT
Study was conducted under a Special Protocol Assessment agreed to with
the U.S. Food and Drug Administration (FDA).
“We are disappointed that the HEAT Study did not provide sufficient
evidence of clinical effectiveness of ThermoDox® as measured by the
trial’s primary endpoint,” said Michael H. Tardugno, Celsion’s
President and Chief Executive Officer. “We will consider following the
patients currently enrolled in the HEAT Study to the secondary
endpoint, Overall Survival (OS), and are conducting additional analyses
of the data from the trial in order to assess the future strategic value
of ThermoDox. We expect that the results will be presented in the
future at appropriate medical meetings. We wish to acknowledge and
thank the patients and investigators who participated in the trial.”
2012 with a strong balance sheet that provides the Company the
opportunity to evaluate its future development plans. The Company
projects its unaudited cash and investment balance to be approximately $23 million as of December 31, 2012 and approximately $27 million as of January 31, 2013.
The Company is hosting a conference call to discuss the Phase III HEAT Study results at 8:00 a.m. EST today. To participate in the call, interested parties may dial 1-888-466-4462 (Toll-Free/North America)
or 1-719-457-2627 (International/Toll) and ask for the Celsion
Corporation Phase III HEAT Study Conference Call approximately 10
minutes before the call is scheduled to begin. The call will also be
broadcast live on the internet at http://www.celsion.com.
The call will be archived for replay at 2 p.m. EST on January 31, 2013, and will remain available until February 14, 2013. The replay can be accessed at 1-877-870-5176 (Toll-Free/North America)
or 1-858-384-5517 (International/Toll) using Conference ID: 4540212. An
audio replay of the call will also be available on the Company’s
website, http://www.celsion.com, for 30 days after 2p.m. EST on Thursday, January 31, 2013.
About the HEAT Study
HEAT (Hepatocellular Carcinoma Study of RFA and ThermoDox®)
was an international, multi-center, randomized, placebo-controlled
study that randomized 701 patients with intermediate (tumor size 3 cm to
7 cm), unresectable HCC to 50mg/m2 ThermoDox® plus RFA or
RFA alone. The primary endpoint of the study was progression-free
survival, as defined by the Special Protocol Assessment agreed to with
the U.S. FDA. Safety and tolerability were also evaluated.
The HEAT Study, the largest clinical trial to date in patients with
intermediate HCC, was conducted at 79 clinical sites around the world,
including the United States, Canada, Italy, China, Taiwan, Hong Kong, Korea, Thailand, Malaysia and the Philippines.
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC), also known as primary liver cancer,
is currently one of the most common and deadly forms of cancer
worldwide. With few approved treatment options, it is estimated that up
to 90 percent of unresectable (inoperable) liver cancer patients will
die within five years of diagnosis. HCC is the fourth leading cause of
death from cancer and the third most common in males. There are
approximately 26,000 new cases per year in the US and approximately
40,000 cases per year in Europe.
However, HCC is rapidly growing worldwide at approximately 750,000
cases per year, due to the high prevalence of Hepatitis B and C in
developing countries – more than 50 percent of these new cases will be
. HCC currently is the world’s fifth largest cancer and the World Health Organization estimates that HCC may become the number one cancer worldwide by 2020, surpassing lung cancer.
ThermoDox® is an investigational, proprietary heat-activated
formulation of liposomal doxorubicin, an approved and frequently used
oncology drug for the treatment of a wide range of cancers, and is
currently being investigated in clinical trials for its potential to
treat patients with intermediate (tumor size 3 to 7 cm), unresectable
(inoperable) HCC. ThermoDox® is an investigational treatment and is not
approved by the FDA, EMA or other health authorities.
ThermoDox® enhances the efficacy of doxorubicin by encapsulating it with Celsion’s
proprietary lysolipid thermally sensitive liposomes (LTSL). These
heat-sensitive liposomes change structure when heated to a specific
temperature (via a heat source like RFA), creating openings in the
liposome that release doxorubicin directly into the targeted tumor and
surrounding tissue. While the RFA targets the tumor, ThermoDox® delivers
higher concentrations of chemotherapy directly to the tumor site,
capturing micrometastases (tumors too miniscule to be detected) outside
of the RFA ablation zone, which are most commonly responsible for
post-treatment disease recurrence. In animal models, ThermoDox® has
been shown to deliver 25 times more doxorubicin into tumors than
intravenous doxorubicin, and five times more doxorubicin
than standard liposomal formulations of the drug. Additionally,
ThermoDox® is less permeable across normal blood vessels than free
doxorubicin, minimizing systemic toxicity.
About Celsion Corporation
Celsion is a
leading oncology company dedicated to the development and
commercialization of innovative cancer drugs. The company is focused on
advancing its heat-mediated, tumor-targeting drug delivery platform to
address difficult-to-treat cancers. Celsion has research, license, or commercialization agreements with leading institutions including the National Institutes of Health, Duke University Medical Center, University of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the Kyungpook National
University Hospital, the Beijing Cancer Hospital and the University of Oxford. For more information on Celsion, visit our website: http://www.celsion.com.
SOURCE Celsion Corporation