LAWRENCEVILLE, N.J.,
May 2, 2016 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced data from the first cohort of
patients in its Phase Ib dose escalating clinical trial (the
OVATION Study) 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. 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. The three patients were
treated at the University of Alabama at
Birmingham.
"These results, while early, are very impressive and speak to
the potential of GEN-1 to improve patient outcomes in ovarian
cancer," said Ronald D. Alvarez,
M.D., Professor, Division of Gynecologic Oncology at the
University of Alabama at Birmingham.
"In particular, we see improvements across a number of
important and meaningful measures used to assess ovarian cancer,
which reinforce our confidence in this IL-12 immunotherapy approach
and provide a strong rationale for continued development of GEN-1
for the treatment of ovarian cancer."
OVATION Study - First Cohort Results
- 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 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 pCR¹.
- 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.
"These results build on the impressive clinical findings we
observed in the GOG Study as well as the translational data from
this same study reported earlier this year. As we move closer
towards initiating a Phase I/II trial to evaluate the synergistic
anti-cancer effects of GEN-1 together with Avastin® and Doxil®,
these results also provide strong validation for the potential of
GEN-1 in ovarian cancer," said Michael H.
Tardugno, Celsion's chairman, president and chief executive
officer. "We will continue to evaluate the maturing dataset from
the OVATION study, and may evaluate ways to leverage insights from
this trial to help accelerate the clinical development of this
highly promising therapy and inform the design of future
studies."
The OVATION Study will continue into 2016 at higher doses of
GEN-1 with the goal to identify a safe, tolerable and
therapeutically active dose of GEN-1 by recruiting and maximizing
an immune response. Celsion has initiated four clinical sites at
the University of Alabama at
Birmingham; Oklahoma University
Medical Center; Washington University
in St. Louis and the Medical College of Wisconsin. The trial is designed
to enroll three to six patients per dose cohort and will evaluate
safety and efficacy and attempt to define an optimal dose.
Future studies of GEN-1 will include a Phase I/II study
combining GEN-1 with Avastin® and Doxil®. With the second cohort
fully enrolled, Celsion expects to complete the OVATION Study this
year.
GOG Study - GEN-1 Data
Celsion also recently announced clinical data from a
dose-escalation study evaluating GEN-1 plus Doxil® in platinum
resistant ovarian cancer (the GOG Study). In the GOG Study,
at the highest dose level, GEN-1 plus Doxil® produced an objective
response rate (ORR) of 29%. This compares favorably to the
data from the Phase 3 AURELIA trial in platinum-resistant ovarian
cancer, which demonstrated that Avastin® plus chemotherapy produced
an ORR of 27%. Historical data for trials evaluating Doxil®
monotherapy in platinum resistant ovarian cancer suggest an ORR of
only 8% to 12%.
Translational data from the GOG Study reported in January 2016 is highlighted below:
- Intraperitoneal administration of GEN-1 in platinum-resistant
ovarian cancer patients resulted in a significant increase in IL-12
levels in peritoneal fluid samples. IL-12 levels were quantifiable
in 91% of evaluable fluid samples collected post GEN-1 treatment.
None of the evaluable pre-treatment peritoneal fluid samples had
any detectable IL-12 levels.
- The IL-12 levels were detectable for at least seven days after
GEN-1 treatment.
- In comparison to peritoneal fluid, the IL-12 levels in plasma
samples (systemic exposure) following GEN-1 treatment were not
detectable or were very low in quantity.
- Significant increases in levels of IFN-γ, a key downstream
mediator of IL-12 action, were observed in peritoneal fluid but not
in plasma samples. At least a 5-fold increase above pre-treatment
level in IFN- γ was observed in most samples, with the highest
increase observed at 120-fold. Similar results were observed with
TNF-α levels, with the highest increase observed at 77-fold over
pre-treatment control.
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.
¹Petrillo M, Zannoni GF, Tortorella L, et al. Prognostic role
and predictors of complete pathologic response to neoadjuvant
chemotherapy in primary unresectable ovarian cancer. American
Journal of Obstetrics & Gynecology 2014
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