LAWRENCEVILLE, N.J.,
March 16, 2016 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced that its preclinical data for
GEN-1 in combination with Avastin® and Doxil® for the treatment of
ovarian cancer will be presented at the upcoming AACR Annual
Meeting 2016 in New Orleans. The presentation will be held on
Monday, April 18, 2016 (1:00 pm to 5:00 pm) and will summarize results
from preclinical studies demonstrating significant synergistic
anti-cancer effects when GEN-1 is combined with Avastin® and
Doxil®, a current Standard of Care (SoC) for platinum resistant
ovarian cancer patients. GEN-1 is an IL-12 DNA plasmid vector
formulated into a nanoparticle with a non-viral delivery system to
cause the sustained local production and secretion of the
Interleukin-12 (IL-12) protein loco-regionally to the tumor
site. These data will be used by the Company to support a
comprehensive IND protocol filing for a Phase I/II clinical trial
evaluating the combination in recurrent ovarian cancer later this
year.
"The immune stimulating nature of GEN-1 in combination with
Avastin® and Doxil®, two of the most widely used cancer therapies,
makes for an ideal therapy, bolstering the anti-cancer effect
beyond what has been observed when used alone," said Nicholas Borys, M.D., senior vice president and
chief medical officer of Celsion. "Results from this important
study are highly encouraging and suggest that when these therapies
are combined, they offer the potential to significantly reduce
tumor burden and disease progression in this highly aggressive
cancer in patients who have failed first line platinum-based
therapies."
Data is emerging on how SoC chemotherapy treatments influence
the immune response in cancers that they are
targeting. Chemotherapy stimulates the immune system by (i)
making the dying tumor cells more visible to the body's immune
system through the release of tumor antigens; (ii) destroying the
immune suppression caused by the tumor; and (iii) directly or
indirectly affecting immune cells and immune modulators.
Chemotherapy treatments may be a good candidate for combination
with immune-mediating therapies like GEN-1. Doxorubicin increases
not only T-cell and natural killer (NK) cell production, but also B
cells (anti-tumor antibodies) in ovarian cancer. IL-12 is a
highly active cytokine that can induce a potent anti-cancer
immunity mediated through the activation of cytotoxic T-lymphocytes
and NK cells and the inhibition of immune-suppressing regulatory
T-cells.
Clinical data supporting the combination of GEN-1 with SoC
chemotherapies
GEN-1 has already demonstrated encouraging safety and efficacy
clinical data in combination with PEGylated liposomal doxorubicin
(Doxil®) in patients with platinum-resistant ovarian cancer.
Results from a Phase Ib clinical trial in platinum resistant
ovarian cancer patients have shown that intraperitoneal delivery of
GEN-1 in combination with Doxil® produced an overall clinical
benefit of 57.1% (PR=21.4%; SD=35.7%) in patients with measurable
disease. The highest percentage of PRs were found at the highest
dose level (28.6%) along with the highest percentage of patients
achieving SD (57.1%) producing an overall clinical response rate
(CR+PD+SD) of 86% at the highest GEN-1 dose cohort, which, despite
a small study size, is highly encouraging considering the poor
outcome with Doxil alone in this patient population.
GEN-1 has also produced encouraging data in combination with
Avastin® alone in earlier preclinical studies in a model of ovarian
cancer, leading to a significant reduction in tumor burden and
disease progression. The inhibition of VEGF by IL-12 through the
secretion of interferon-gamma may help explain the impressive
synergies between GEN-1 and SoC anti-angiogenic agents like
Avastin. These findings open up an additional combination
therapy of Avastin with an immune-based therapy like GEN-1.
Preclinical data supporting the combination of GEN-1 with SoC
Chemotherapy + Avastin
Results from comprehensive studies confirmed remarkable,
statistically significant initial GEN-1 + Avastin findings. Recent
studies now show convincingly that GEN-1 when combined with
Avastin® and Doxil® demonstrated a greater than 98% reduction in
tumor burden when compared to the untreated control group. The
findings represent a statistically significant reduction in tumor
burden and disease progression when compared to the combination of
Avastin® and Doxil® in a SKOV3 human cell line implanted into
immunocompromised (nude) mice. Analysis of serum chemistry and
hematology suggested no overt toxicities associated with the
combined treatments. The preclinical data are consistent with the
mechanism of action for GEN-1, which exhibits certain
anti-angiogenic properties in addition to its well-characterized
immunomodulatory activities.
"We believe that the synergy provided to the tumor
micro-environment by GEN-1 is responsible for our remarkable
preclinical findings," said Michael
Tardugno, chairman, chief executive officer and president of
Celsion. "Local cellular production and secretion of
highly-tolerable endogenous IL-12, a multi-mechanistic anti-cancer
agent, both supports doxorubicin's immune system activating
potential as well as reinforces the anti-angiogenic properties of
one of the world's most prescribed anti-cancer biologics,
Avastin. We are excited to move forward into clinical trials
with the potential for a ground breaking therapeutic approach."
The Company is currently enrolling patients in the OVATION
Study, a Phase 1b dose escalating trial combining GEN-1 with
neo-adjuvant therapies in newly diagnosed ovarian cancer patients
which will provide a starting dose for the follow-on Phase 1/2
study combining GEN-1 with Avastin® and Doxil®. The Phase 1/2
combination trial is expected to begin in
mid-2016.
About GEN-1 Immunotherapy
GEN-1, designed using Celsion's proprietary 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, and recently completed a Phase Ib
trial of GEN-1 in combination with PEGylated doxorubicin in
patients with platinum-resistant ovarian cancer. 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 in the second half of 2015.
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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