LAWRENCEVILLE, N.J.,
June 1, 2015 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN), a fully integrated oncology drug
development company, announced the presentation of clinical results
from its Phase IB trial for GEN-1 in platinum-resistant ovarian
cancer in a poster session by Dr. Premal H.
Thaker, M.D., associate professor at Washington University and Siteman Cancer Center in
St. Louis, on Saturday, May 30th at the 2015 American Society
of Clinical Oncology (ASCO) Meeting in Chicago. GEN-1 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. The poster presentation is available
on Celsion's website at http://www.celsion.com.
The Phase 1B dose escalating study enrolled 16 patients with
platinum-resistant ovarian cancer and evaluated the safety,
tolerability and efficacy of GEN-1 in combination with pegylated
doxorubicin as well as the effect of intraperitoneal injection of
GEN-1 on IL-12 and tumor cytokine levels. Patients received
pegylated liposomal doxorubicin on day 1 and GEN-1 on days 1, 8, 15
and 22. This treatment regimen was repeated every 28 days in the
absence of disease progression or toxicity.
The clinical findings demonstrated an overall clinical benefit
of 57% for all treatment arms, with a partial response (PR) rate of
21% and a stable disease (SD) rate of 36%. The overall clinical
benefit observed at the highest dose cohort in this
difficult-to-treat patient population was 100% (PR=33% and SD=67%)
in all six evaluable patients. GEN-1 was well tolerated, with no
dose limiting toxicities and no overlapping toxicities between
GEN-1 and pegylated doxorubicin.
"These clinical results are very encouraging, especially given
the fact that patients suffering from
advanced relapsed ovarian cancer have typically failed
previous treatments and have limited treatment options for this
aggressive cancer. GEN-1 is a novel immunotherapy designed to
enhance the patient's immune system to help the body treat and
fight cancer," said Dr. Thaker. "I am pleased to be part of this
important study and look forward to continuing my involvement with
future trials of GEN-1 IL-12 immunotherapy in this underserved
patient population."
Additional translational data measuring cytokine levels
(IFN-gamma and TNF-alpha) at increased doses of GEN-1 will be
available after the ASCO Meeting. Since the maximum tolerated
dose was not reached in this study, Celsion plans to evaluate GEN-1
in a Phase 1 dose escalating trial in first line neoadjuvant
ovarian cancer. Based on the significant clinical benefit
observed in the Phase 1B study coupled with compelling preclinical
data, the Company also plans to initiate a Phase 1B dose escalating
trial evaluating GEN-1 plus Avastin® and Doxil® in
platinum-resistant ovarian cancer patients, a combination which has
the potential to significantly improve treatment outcomes for these
patients.
In two preclinical studies using an animal model of disseminated
ovarian cancer, GEN-1 in combination with Avastin® led to a
significant reduction in tumor burden and disease
progression. The effectiveness of the combined treatment was
seen when GEN-1 was combined with various dose levels of Avastin®
(low-medium-high). The preclinical studies indicated that no
obvious overt toxicities were associated with the combined
treatments.
The preclinical data are also consistent with the mechanism of
action for GEN-1, which exhibits certain anti-angiogenic properties
and suggests that combining GEN-1 with lower doses of Avastin® may
enhance efficacy and help reduce the known toxicities associated
with this anti-VEGF drug.
The distinct biological activities of GEN-1 (immune stimulation)
and Avastin® (inhibition of tumor blood vessel formation) makes a
sound scientific rationale for this combination approach.
Additionally, the anti-angiogenic activity of GEN-1 mediated
through up regulation of the interferon gamma (IFN-gamma) pathway may help to explain the
remarkable synergy between GEN-1 and Avastin® and potentially
addresses the VEGF escape mechanisms associated with resistance to
Avastin® therapy.
"This impressive body of clinical and preclinical data warrants
the continued development with escalating doses of GEN-1 and
underscores the potential clinical utility of this immunotherapy in
difficult-to-treat diseases like recurrent ovarian cancer," said
Michael H. Tardugno, Celsion's
chairman, president and chief executive officer.
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 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
Senior Vice President and CFO
609-482-2455
jchurch@celsion.com
Celsion Media Contacts
Harriet Shelare
Director, Communications
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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SOURCE Celsion Corporation