LAWRENCEVILLE, N.J.,
Jan. 6, 2015 /PRNewswire/ -- Celsion
Corporation (Celsion) (NASDAQ:CLSN), a fully-integrated oncology
company focused on the development of a portfolio of innovative
cancer treatments, including directed chemotherapies,
immunotherapies and RNA- or DNA-based therapies for the treatment
of cancer and other difficult-to-treat diseases, today announced
the submission of its Phase I clinical trial protocol to the U.S.
Food and Drug Administration (FDA) for GEN-1, the Company's
DNA-based immunotherapy for the localized treatment of
cancer. The protocol, developed with guidance from the
Company's Medical Advisory Board, is designed to establish a safe
dose and biological activity of GEN-1 in newly diagnosed ovarian
cancer patients who will be undergoing neoadjuvant chemotherapy.
GEN-1 has demonstrated encouraging safety and efficacy data
in a previous Phase I monotherapy trial in patients with
peritoneally metastasized ovarian cancer, and is currently being
evaluated in a Phase Ib trial in combination with PEGylated
doxorubicin in patients with platinum-resistant ovarian cancer.
"GEN-1 is designed to locally activate IL-12 production which
can stimulate the patient's immune system to attack and destroy
cancer," stated Dr. Nicolas Borys,
Celsion's Senior Vice President and Chief Medical Officer.
"In preclinical and clinical studies performed to date, GEN-1 has
demonstrated good safety and impressive immune system stimulation
and activity, and this trial will evaluate its value as an adjuvant
to chemotherapy in patients with a relatively healthy immune
system. We now look forward to initiate the study in the second
half of this year."
The clinical study will identify a safe and tolerable dose of
GEN-1 while maximizing an immune response. The protocol
intends to enroll 3 to 6 patients per dose level until a safe,
tolerable and potentially therapeutically active dose is
identified. The protocol has been submitted to the FDA for
its 30 day review and comment period. Pending this review,
the Company expects to initiate enrollment in the second half of
2015.
"Developing more effective immunotherapy approaches to ovarian
cancer is a high priority for those of us who care for the
thousands of patients affected by advanced ovarian cancer.
GEN-1 is a novel IL-12 expressing lipopolymer that has
demonstrated promising activity in preclinical and early phase
clinical trials in ovarian cancer," stated Ronald D. Alvarez, MD, Professor and Director of
the Division of Gynecologic Oncology at the University of Alabama at Birmingham (UAB) and a
member of the Company's Medical Advisory Board. "The proposed
trial to use GEN-1 in combination with neoadjuvant chemotherapy
will provide a unique opportunity to assess how cytokine-based
compounds such as GEN-1 directly affect ovarian cancer cells and
the tumor microenvironment in newly diagnosed patients."
"GEN-1 holds tremendous promise as a potential cancer treatment
in the rapidly emerging area of immuno-oncology. Unlike the
toxicities, poor tolerability, and poor pharmacokinetics of
systemically administered recombinant IL-12, the beauty of GEN-1 is
that it inspires secretion of highly-tolerable endogenous IL-12,"
said Michael H. Tardugno, the
Company's Chairman, President and Chief Executive Officer.
"Designed in consultation with leading thought leaders, this Phase
I trial is expected to define an optimal dose, potentially an
enhanced population, and provide insights on powering for a
registration program as the candidate progresses through
development."
About GEN-1 Immunotherapy
GEN-1, designed using the TheraPlas™ platform technology, is an
IL-12 DNA plasmid vector encased in a nanoparticle delivery system
which enables cell transfection followed by persistent, local
secretion of the IL-12 protein. IL-12 is one of the most
active cytokines for the induction of potent anti-cancer immunity
acting through the induction of T-lymphocyte and natural killer
(NK) cell proliferation. The Company has previously
reported positive safety and encouraging Phase I results with GEN-1
given as monotherapy in patients with peritoneally metastasized
ovarian cancer. A Phase Ib trial of GEN-1 in combination with
PEGylated doxorubicin in patient with platinum-resistant ovarian
cancer is currently ongoing. GEN-1 has also demonstrated
preclinical activity in glioblastoma multiforme (brain cancer) and
the Company plans to initiate a Phase I study in this
indication.
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.
The pipeline also includes EGEN-001, a DNA-based immunotherapy for
the localized treatment of ovarian and brain cancers. Celsion
has three platform technologies for the development of novel
nucleic acid-based immunotherapies and other anti-cancer DNA or RNA
therapies, including TheraPlas™, TheraSilence™ and RAST ™.
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 or the possible failure to make such acquisitions or
licenses; 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
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SOURCE Celsion Corporation