Galena Biopharma Receives Two Orphan Drug Designations for GALE-301 and GALE-301/GALE-302
June 10 2016 - 2:47PM
Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
committed to the development and commercialization of targeted
oncology therapeutics that address major unmet medical needs, today
announced the U.S. Food and Drug Administration (FDA) has granted
two orphan-drug designations for Galena’s two cancer immunotherapy
peptides derived from Folate Binding Protein (FBP) for the
treatment (including prevention of recurrence) of ovarian cancer:
one for GALE-301 (E39), and one for GALE-301 (E39) and GALE-302
(E39’). In clinical trials, GALE-301, and GALE-301/GALE-302 are
combined with the immune adjuvant, granulocyte macrophage-colony
stimulating factor (GM-CSF) for the treatment of ovarian cancer in
the adjuvant setting.
“Ovarian cancer is a very aggressive disease with almost fifty
percent of women recurring within five years after their initial
treatment1,” said Mark W. Schwartz, Ph.D., President and Chief
Executive Officer. “This designation supports our efforts to
advance our FBP-targeted immunotherapy program consisting of
GALE-301 and GALE-302 to prevent cancer recurrence in this
underserved patient population.”
The Orphan Drug Designation program provides orphan status to
drugs and biologics which are defined as those intended for the
safe and effective treatment, diagnosis or prevention of rare
diseases/disorders that affect fewer than 200,000 people in the
U.S.2 Orphan designation qualifies the sponsor of the drug for
various development incentives including marketing exclusivity in
the U.S. for seven years after product approval3, tax credits, and
exemption from the prescription drug user fee.
Sources: 1U.S. Ovarian Cancer
http://seer.cancer.gov/statfacts/html/ovary.html; 2FDA Website -
Developing Products for Rare Diseases & Conditions; 3FDA
Frequently Asked Questions on Patents and Exclusivity
About GALE-301 and GALE-302
GALE-301 and GALE-302 are cancer immunotherapies that consist of
a peptide derived from Folate Binding Protein (FBP) combined with
GM-CSF for the treatment (including prevention of recurrence) of
ovarian cancer in the adjuvant setting. GALE-301 is the E39
peptide, while GALE-302 is an attenuated version of this peptide,
known as E39’. FBP is a well-validated therapeutic target
that is highly over-expressed in ovarian, endometrial and breast
cancers, and is the source of immunogenic peptides that can
stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy
FBP-expressing cancer cells. Two trials are ongoing with FBP
peptides in gynecological cancers: the GALE-301 Phase 2a portion of
the Phase 1/2a clinical trial is ongoing in ovarian and endometrial
adenocarcinomas (ClinicalTrials.gov Identifier: NCT01580696); the
GALE-301 plus GALE-302 Phase 1b clinical trial is ongoing in breast
and ovarian cancers (ClinicalTrials.gov Identifier:
NCT02019524).
About Ovarian Cancer
New cases of ovarian cancer occur at an annual rate of 12.1 per
100,000 women in the U.S., with an estimated 21,290 cases for 2015.
Although ovarian cancer represents about 1.3% of all cancers, it
represents about 2.4% of all cancer deaths, or an estimated 14,180
deaths in 2015. Approximately 1.3% of women will be diagnosed
with ovarian cancer at some point during their lifetime (2010 –
2012 data). The prevalence of ovarian cancer in the U.S. is
about 192,000 women, and the five-year survivorship for women with
ovarian cancer is 45.6%.
Due to the lack of specific symptoms, the majority of ovarian
cancer patients are diagnosed at later stages of the disease, with
an estimated 75% of women presenting with advanced-stage (III or
IV) disease. These patients have their tumors routinely surgically
debulked to minimal residual disease, and then are treated with
platinum- and/or taxane-based chemotherapy. While many patients
respond to this treatment regimen and become clinically
free-of-disease, the majority of these patients will relapse.
Depending upon their level of residual disease, the risk for
recurrence after completion of primary therapy ranges from 60% to
85%. Unfortunately for these women, once the disease recurs,
treatment options are limited and the disease remains
incurable.
Source: National Cancer Institute Surveillance, Epidemiology,
and End Results Program
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company committed
to the development and commercialization of targeted oncology
therapeutics that address major unmet medical needs. Galena’s
development portfolio is focused primarily on addressing the
rapidly growing patient populations of cancer survivors by
harnessing the power of the immune system to prevent cancer
recurrence. The Company’s pipeline consists of multiple mid- to
late-stage clinical assets, including novel cancer immunotherapy
programs led by NeuVax™ (nelipepimut-S) and GALE-301. NeuVax
is currently in a pivotal, Phase 3 breast cancer clinical trial
with several concurrent Phase 2 trials ongoing both as a single
agent and in combination with other therapies. GALE-301 is in a
Phase 2a clinical trial in ovarian and endometrial cancers and in a
Phase 1b given sequentially with GALE-302. For more
information, visit www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to,
statements about the progress of the development of Galena’s
product candidates, including GALE-301 and GALE-302, patient
enrollment in our clinical trials, as well as other statements
related to the progress and timing of our development activities,
present or future licensing, collaborative or financing
arrangements, expected outcomes with regulatory agencies, and
projected market opportunities for product candidates or that
otherwise relate to future periods. These forward-looking
statements are subject to a number of risks, uncertainties and
assumptions, including those identified under “Risk Factors” in
Galena’s Annual Report on Form 10-K for the year ended December 31,
2015 and most recent Quarterly Reports on Form 10-Q filed with the
SEC. Actual results may differ materially from those contemplated
by these forward-looking statements. Galena does not undertake to
update any of these forward-looking statements to reflect a change
in its views or events or circumstances that occur after the date
of this press release.
NeuVax is a trademark of Galena Biopharma, Inc.
Contact:
Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com
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