Celsion’s GEN-1 Immunotherapy Receives Orphan Drug Designation from the European Medicines Agency
March 23 2020 - 8:00AM
Celsion Corporation (NASDAQ: CLSN), a leading oncology drug
development company, today announced the European Medicines Agency
(EMA) Committee for Orphan Medicinal Products (COMP) has
recommended that GEN-1 be designated as an orphan medicinal product
for the treatment of ovarian cancer. GEN-1, designed using
Celsion's proprietary TheraPlas platform technology, is an
interleukin-12 (IL-12) DNA plasmid vector encased in a non-viral
nanoparticle delivery system, which enables cell transfection
followed by persistent, local secretion of the IL-12 protein. GEN-1
previously received orphan designation from the U.S. Food and Drug
Administration and is currently being evaluated in a Phase I/II
clinical trial (the OVATION 2 Study) for the treatment of newly
diagnosed patients with Stage III and IV ovarian cancer.
The OVATION 2 Study combines GEN-1 with the
standard of care for the treatment of newly diagnosed patients with
Stage III and IV ovarian cancer who will undergo standard
neoadjuvant chemotherapy followed by interval debulking surgery.
The OVATION 2 Study is a randomized Phase I/II study designed to
evaluate the safety of 100 mg/m² of GEN-1 in the Phase I portion,
followed by a continuation at the safe dose in the Phase II portion
in an open-label, 1:1 randomized design.
"EMA's orphan drug designation for GEN-1
recognizes the urgent need for new therapies to treat ovarian
cancer, an aggressive, rapidly progressing disease with few
effective treatment options," stated Michael H. Tardugno, Celsion's
chairman, president and chief executive officer. "We are pleased to
receive a positive opinion from EMA COMP as this Designation
carries multiple benefits and represents another important
milestone for our clinical program to treat late-stage ovarian
cancer.”
As established by the EMA, Orphan Medicinal
Product Designation (the “Designation”) by the European Commission
provides for scientific advice and certain regulatory assistance
during the product development phase, direct access to centralized
marketing authorization and certain financial incentives for
companies developing new therapies intended for the treatment of a
life-threatening or chronically debilitating condition that affects
no more than five in 10,000 people in the European Union (EU).
Benefits for the Designation are manifold and
include:
- 10 years of market exclusivity (in which other industry
sponsors are prevented from entering the market with a similar
product for the same therapeutic indication);
- EMA protocol assistance for sponsors on the conduct of the
tests and trials necessary to demonstrate their quality, safety and
efficacy, or regulatory assistance;
- EMA advice will be free or given in return for reduced
fees;
- Access to a centralized procedure allowing immediate marketing
authorization in all Member States and facilitating the
availability of medicines to all patients in the EU;
- Eligibility for a reduction of regulatory fees associated with
pre-authorization inspections, as well as, marketing authorization
application fees and certain other fees for qualifying
companies.
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 GEN-1, a DNA-based
immunotherapy for the localized treatment of ovarian cancer.
Celsion has two platform technologies for the development of novel
nucleic acid-based immunotherapies and other anti-cancer DNA or RNA
therapies. 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; 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 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 |
LHA
Investor Relations |
Jeffrey W.
Church, EVP, CFO and Corporate Secretary |
Kim Sutton
Golodetz |
609-482-2455 |
212-838-3777 |
jchurch@celsion.com |
kgolodetz@lhai.com |
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