LAWRENCEVILLE, N.J.,
May 24, 2016 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN), an oncology drug development company,
today provided an update on its ongoing OVATION study, a Phase Ib
dose escalating clinical trial combining GEN-1, the Company's
DNA-based immunotherapy, with the standard of care for the
treatment of newly-diagnosed patients with advanced ovarian cancer
who will undergo neoadjuvant chemotherapy followed by interval
debulking surgery. GEN-1 is an IL-12 DNA plasmid vector
formulated as a nanoparticle in 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.
The Company announced that an abstract detailing the trial
design of the OVATION Study has been accepted for presentation at
the American Society of Clinical Oncology (ASCO) Annual Meeting,
which will take place from June 3-7
in Chicago. The abstract,
entitled "Phase 1 study of the safety and biological activity of
intraperitoneal IL-12 plasmid formulated with PEG-PEI-cholesterol
lipopolymer administered in combination with standard neoadjuvant
chemotherapy (NAC) in patients with newly diagnosed ovarian
cancer," will be presented in a poster session on Monday, June 6th from 1:00
PM to 4:00 PM.
The Company also announced today that it has completed
enrollment of the second cohort of the OVATION Study and expects to
report clinical data from that cohort mid-year. Celsion has
previously reported highly encouraging data from the first cohort
of the OVATION Study. In the first three patients dosed,
GEN-1 plus standard chemotherapy produced excellent results, with
no dose limiting toxicities and highly promising efficacy signals
leading to successful surgical outcomes as summarized below:
- Of the three patients treated in the first cohort, two patients
demonstrated stable disease (SD) and one patient demonstrated a
complete response (CR), as measured by RECIST criteria.
- All patients had successful resections of their tumors, with
two patients having an R0 resection, which indicates a
microscopically margin-negative resection in which no gross or
microscopic tumor remains in the tumor bed, and one patient with
Stage IV ovarian cancer having an optimal R1 resection.
- One patient demonstrated a pathological complete response
(pCR). pCRs are typically seen in less than 7% of patients
receiving neoadjuvant chemotherapy followed by surgical resection,
and have been associated with a median overall survival (OS) of 72
months, which is more than three years longer than those who do not
experience a pCR.
- All patients experienced a dramatic > 96% drop in their
CA-125 protein levels as of their most recent study visit. CA-125
is used to monitor certain cancers during and after treatment.
CA-125 is present in greater concentrations in ovarian cancer cells
than in other cells. A 50% reduction in CA-125 levels is considered
meaningful. All patients' CA-125 levels were below the standard
cutoff level of 35 U/mL.
Celsion also expects to report translational data from the first
two cohorts of the OVATION Study early in the third quarter of
2016. The translational data will provide further insight
into GEN-1's mechanism of action through the evaluation of
dose-related changes in the tumor and peritoneal immune cell
population, as well as through the peritoneal cytokine levels.
Moreover, immune cell density, a common indicator of survival in
ovarian cancer patients, will be explored to further demonstrate
the therapy's efficacy in these patients.
"We continue to successfully execute our OVATION Study in newly
diagnosed ovarian cancer patients, and are pleased to report that
our second cohort is now fully enrolled," said Michael H. Tardugno, Celsion's chairman,
president and CEO. "The translational and clinical data seen to
date underscore the potential efficacy and safety profile of GEN-1,
and we look forward to learning more about the utility of our
gene-based immunotherapy approach as our data set matures."
OVATION Study Design
The Phase Ib trial will evaluate weekly intraperitoneal dosing
of GEN-1 in combination with neoadjuvant chemotherapy, the standard
of care for patients newly diagnosed with ovarian cancer.
Concurrently with neoadjuvant chemotherapy, enrolled patients will
receive escalating weekly doses of GEN-1, from levels beginning at
36mg/m², to 47mg/m², 61mg/m², 79mg/m², and up to 103mg/m² weekly
for 8 treatments in total, with interval debulking surgery to
follow. The regimen will primarily be evaluated for its safety and
tolerability.
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.
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 (CLSN-G1 CLSN-OV).
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
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/celsion-announces-presentation-of-ovation-study-clinical-trial-design-at-upcoming-asco-2016-meeting-300273558.html
SOURCE Celsion Corporation