Galena Biopharma to Present GALE-301 Phase 2a Clinical Trial Data at the European Society for Medical Oncology (ESMO) Europea...
September 21 2015 - 8:46PM
Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
therapeutics that address major medical needs across the full
spectrum of cancer care, today announced that data from the
Company's Phase 2a portion of the Phase 1/2a clinical trial of
GALE-301, or Folate Binding Protein, will be presented at the
upcoming European Society for Medical Oncology (ESMO) European
Cancer Congress 2015 in Vienna, Austria. Details of the poster
presentation are as follows:
Poster #: |
P427 |
Abstract #: |
2764 – the abstract can be found on the
conference website here |
Title: |
Preliminary results of the phase I/IIa dose
finding trial of a folate binding protein vaccine (E39+GM-CSF) in
ovarian and endometrial cancer patients |
|
to prevent recurrence |
Session Title: |
Gynaecological Cancer |
Date: |
Monday, September 28, 2015 |
Time: |
9:15 a.m. to 11:15 a.m. local time |
Location: |
Hall C |
About GALE-301 GALE-301 is a cancer
immunotherapy that consists of a peptide derived from Folate
Binding Protein (FBP), combined with the immune adjuvant,
granulocyte macrophage-colony stimulating factor (GM-CSF) for the
prevention of cancer recurrence in the adjuvant setting. FBP
is a well-validated therapeutic target that is highly
over-expressed in ovarian, endometrial and breast cancers. FBP is
the source of immunogenic peptides that can stimulate cytotoxic T
lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer
cells. Enrollment has been completed in the GALE-301 Phase 2a
portion of the Phase 1/2a clinical trial in two gynecological
cancers: ovarian cancer and endometrial adenocarcinomas
(clinicaltrials.gov identifier: NCT01580696).
About Ovarian/Endometrial Cancers
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 US 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 most 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.
New cases of endometrial cancer occur at an annual rate of 25.1
per 100,000 women in the U.S., with an estimated 54,870 cases for
2015. Although endometrial cancer represents about 3.3% of all
cancers, it represents about 1.7% of all cancer deaths, or an
estimated 10,170 deaths in 2015. Approximately 2.8% of women will
be diagnosed with endometrial cancer at some point during their
lifetime (2010 – 2012 data). The prevalence of endometrial
cancer in the US is about 620,000 women, and the five-year
survivorship for women with endometrial cancer is 81.7%.
Source: National Cancer Institute Surveillance, Epidemiology,
and End Results Program
About Galena Biopharma
Galena Biopharma, Inc. (NASDAQ:GALE) is a biopharmaceutical
company developing and commercializing innovative, targeted
oncology therapeutics that address major medical needs across the
full spectrum of cancer care. Galena's development
portfolio ranges from mid- to late-stage clinical assets, including
a robust immunotherapy program led by NeuVax™ (nelipepimut-S)
currently in an international, Phase 3 clinical trial. The
Company's commercial drugs include Abstral® (fentanyl) Sublingual
Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively,
Galena's clinical and commercial strategy focuses on identifying
and advancing therapeutic opportunities to improve cancer
care, from direct treatment of the disease to the reduction of
its debilitating side-effects. 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 commercialization of our
commercial products and development of Galena's product candidates,
including GALE-301, 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 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, 2014 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.
Abstral and NeuVax are trademarks of Galena Biopharma,
Inc. All other trademarks are the property of their respective
owners.
CONTACT: Remy Bernarda
SVP, Investor Relations & Corporate Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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