Galena Biopharma Completes Enrollment in GALE-301 Phase 2a Clinical Trial in Ovarian and Endometrial Cancers
June 17 2014 - 7:05AM
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
treatments that address major unmet medical needs to advance cancer
care, today announced the completion of enrollment in the Company's
Phase 2a clinical trial for GALE-301, or Folate Binding Protein
(FBP) peptide immunotherapy. GALE-301 is administered to HLA-A2
positive patients in combination with granulocyte macrophage-colony
stimulating factor (GM-CSF) as an adjuvant treatment to prevent
recurrences in high-risk, ovarian and endometrial cancer patients
rendered disease-free after completing standard of care therapy.
The Phase 2a is an open-label trial with two arms consisting of
HLA-A2 positive patients treated with the FBP peptide plus GM-CSF
and an observational control group of HLA-A2 negative patients. The
optimized dose of 1,000 mcg of peptide was determined from the
Phase 1 trial and continued into the Phase 2a along with the
addition of a booster regimen. The trial has completed
enrollment of 45 patients. After an initial induction series
of six vaccinations given once per month, patients will be
administered booster inoculations at two subsequent 6-month
intervals. The primary objectives of the trial are to measure
the immune response, time to recurrence and overall survival
between treatment arms.
"Completion of enrollment in the GALE-301 Phase 2a clinical
trial ahead of schedule is an important milestone for Galena," said
Mark J. Ahn, Ph.D., President and Chief Executive Officer. "We
are now in the treatment and follow-up phase of the trial with the
expectation of data readout in mid-2015. With promising
results from the Phase 1 trial, we are encouraged to advance the
GALE-301 program forward to prevent recurrence in women suffering
from gynecological cancers."
As reported in a poster presentation at the American Society of
Clinical Oncology (ASCO) 50th Annual Meeting earlier this month, 30
patients were enrolled in the GALE-301 Phase 1 trial. Of 14
control patients, 7 (50%) have recurred. Of 16 vaccinated
patients, 4 (25%) have recurred after completing the primary
vaccine series (PVS), 2 (12.5%) recurred prior to completing the
PVS, and one patient discontinued treatment. Of note, no
recurrences have been seen thus far in the optimal dose cohort of
1,000 mcg of peptide.
About GALE-301 (Folate Binding Protein (FBP)
vaccine)
GALE-301 (Folate Binding Protein (FBP)) cancer immunotherapy is
an investigational new drug targeting FBP, a well-validated
therapeutic target, which is highly over-expressed in breast,
ovarian and endometrial cancers. FBP is the source of immunogenic
peptides that can stimulate cytotoxic T lymphocytes (CTLs) to
recognize and destroy presenting FBP-expressing cancer
cells. GALE-301 consists of the FBP peptide(s) combined with
the immune adjuvant, granulocyte macrophage-colony stimulating
factor (GM-CSF). GALE-301 has completed enrollment in a Phase
2a trial in two gynecological cancers: ovarian cancer and
endometrial adenocarcinomas.
About Ovarian/Endometrial Cancers
Ovarian cancer occurs in more than 22,000 patients per year in
the U.S. and is the most lethal gynecologic cancer. Despite the
incidence of ovarian cancer being only approximately 20% of that of
breast cancer, the number of patients that die from ovarian cancer
is nearly 50% of that of breast cancer. Due to the lack of specific
symptoms, the majority of ovarian cancer patients are diagnosed at
later stages of the 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, and once the disease recurs, the treatment options and
successes drop dramatically.
Endometrial cancer is the most common gynecologic cancer and
occurs in more than 46,000 women with more than 8,000 deaths in the
U.S. annually. There are two basic types of endometrial cancer:
endometrioid and papillary serous. The latter has a much more
aggressive clinical course and the majority of these patients will
die of this form of the disease.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company developing and commercializing
innovative, targeted oncology treatments that address major unmet
medical needs to advance cancer care. 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 plans and the prospects for development of
Galena's GALE-301 product candidate. 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,
2013 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.
CONTACT: Remy Bernarda
VP, Marketing & Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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