LAWRENCEVILLE, N.J.,
March 7, 2016 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN), a fully-integrated oncology company
focused on the development of a portfolio of innovative cancer
treatments, today announced the launch of the OPTIMA Study in
China. The Company held an
Investigators' Meeting for the OPTIMA Study on March 5, 2016 in Shanghai, China. Professor Ronnie T.P. Poon, MD, MBBS, MS, PhD, FRCS
(Edin), FACS, Medical Director at the Hong Kong Integrated Oncology
Center, Honorary Professor of Surgery at the University of Hong Kong Queen Mary Hospital, and
member of the International Liver Cancer Association (ILCA)
Governing Board provided the Keynote Address entitled "Treatment
Strategies for Early/Intermediate HCC." Professor
Poon discussed strategies for treating different stages of primary
liver cancer, also known as hepatocellular carcinoma (HCC);
including intermediate stage HCC which has been previously thought
to be incurable. New treatment strategies, most notably an
optimized RFA procedure with the investigational drug, ThermoDox®,
show clear promise as a potential cure for intermediate HCC in the
years ahead. Investigators and their staff from 20 sites in
mainland China and Hong Kong were in attendance. The OPTIMA
Study is the Company's global pivotal, double-blind,
placebo-controlled trial, evaluating
ThermoDox®, Celsion's proprietary heat-activated
liposomal encapsulation of doxorubicin, in combination with
radiofrequency ablation standardized to 45 minutes (sRFA) versus
sRFA alone to treat newly diagnosed patients with HCC.
"Following a very successful Investigator's startup meeting in
Shanghai this past weekend, we are
eager to accelerate site initiation and patient enrollment, and
expect to complete the process already underway by the end of the
second quarter," said Michael H.
Tardugno, Celsion's chairman, president and chief executive
officer. "Our researchers and principal investigators recognize the
importance of the OPTIMA Study to the medical community and its
potential to significantly improve overall survival of newly
diagnosed HCC patients. With approximately 50% of the 850,000 new
cases of primary liver cancer diagnosed each year originating in
China, China represents a significant market
opportunity and key element of our global development strategy for
ThermoDox®."
The Phase III OPTIMA Study is expected to enroll up to 550
patients globally, and has been successfully enrolling patients at
50 clinical sites in 12 different countries in North America, Europe and Asia
Pacific. In December 2015, the
Company announced that it had received a Clinical Trial Application
(CTA) approval from the China Food and Drug Administration (CFDA)
to conduct the ongoing Phase III OPTIMA Study at up to 20
additional clinical sites in China. The Company aims to enroll more than
200 patients in the China
territory, the minimum number required by the CFDA to file a New
Drug Application (NDA), assuming positive clinical results.
"With an extremely high incidence rate of HCC in China, the compelling survival data from the
Chinese subgroup analysis in the HEAT Study underscores the
importance of further exploring the potential that exists for
ThermoDox® in combination with sRFA to serve as a new curative
treatment for primary liver cancer, a disease with limited
treatment options," said Professor Min Hua
Chen, MD, Chief Expert, Department of Ultrasonography,
School of Oncology, Peking University, Lead Investigator for the
OPTIMA Study in China, and former
HEAT Study Investigator. "It is a great honor to be involved with
the OPTIMA Study, and I look forward to working with Celsion and my
research colleagues as the study progresses."
The primary endpoint for the OPTIMA Study is overall survival
(OS). The statistical plan calls for two preplanned interim
efficacy analyses by an independent Data Monitoring Committee
(iDMC). The design of the OPTIMA Study is supported by a
retrospective analysis of a large subgroup of 285 patients in the
Company's previous 701 patient HEAT Study in primary liver cancer.
In a subgroup of 285 HEAT Study participants, ThermoDox® plus
standardized RFA demonstrated a statistically significant
improvement in survival of over two years compared to standardized
RFA alone. In this large subgroup, the median overall survival in
the ThermoDox® plus standardized RFA arm was approximately 80
months (6 ½ years), which is considered a curative treatment for
HCC.
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 and
in Phase II development for the treatment of recurrent chest wall
breast cancer. The pipeline also includes GEN-1, a DNA-based
immunotherapy for the localized treatment of ovarian and brain
cancers. Celsion has two 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: 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; 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; 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
609-482-2455
jchurch@celsion.com
Celsion Media Contacts
Harriet Shelare
Director, Communications
860-483-1721
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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SOURCE Celsion Corporation