Galera Therapeutics Completes Enrollment of Phase 1b/2a Clinical Trial of GC4419 in Combination with Radiotherapy for Locally...
July 13 2020 - 5:46PM
Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage
biopharmaceutical company focused on developing and commercializing
a pipeline of novel, proprietary small molecule therapeutics that
have the potential to transform radiotherapy in cancer, today
announced that it has completed patient enrollment in its pilot
Phase 1b/2a safety and anti-cancer efficacy clinical trial of
avasopasem manganese (GC4419) in combination with stereotactic body
radiation therapy (SBRT) in patients with locally advanced
pancreatic cancer (LAPC).
Galera’s investigational, highly selective small molecule
superoxide dismutase (SOD) mimetics are designed to rapidly and
selectively convert superoxide to hydrogen peroxide and oxygen.
These dismutase mimetics have potential anti-cancer synergy
supported by positive results in multiple preclinical models. The
randomized Phase 1b/2a trial is evaluating the safety,
progression-free survival and overall response rate of GC4419 in
combination with SBRT, compared with SBRT and placebo, in LAPC
patients. The trial is also assessing safety and tolerability to
determine the recommended dose of SBRT when combined with GC4419 or
placebo.
“Pancreatic cancer has one of the poorest survival prognoses of
common cancers and better treatments are urgently needed. Even when
the disease is locally advanced, treatment options have limited
impact on this difficult-to-treat cancer,” said Mel Sorensen, M.D.,
President and CEO of Galera. “This pilot trial is the first to
evaluate the anti-cancer effects of our dismutase mimetics in
combination of SBRT in patients. We look forward to reporting
topline data from this trial in the second half of 2020.”
Additional information on the trial can be found on
clinicaltrials.gov using the identifier NCT03340974.
About GC4419 (Avasopasem Manganese)
Galera’s lead product candidate, avasopasem manganese, is an
investigational, highly selective small molecule superoxide
dismutase (SOD) mimetic that is initially being developed for the
reduction of radiation-induced severe oral mucositis (SOM) which is
not yet approved. Avasopasem is designed to rapidly and selectively
convert superoxide to hydrogen peroxide and oxygen, protecting
normal tissue from damage associated with radiation therapy. Left
untreated, elevated superoxide can damage noncancerous tissues and
lead to debilitating side effects, including oral mucositis (OM),
which can limit the anti-tumor efficacy of radiation therapy.
Avasopasem is currently being studied in the ROMAN trial, a
randomized, double blind, placebo-controlled Phase 3 trial of
approximately 450 patients (NCT03689712, available
at clinicaltrials.gov) to investigate the effects of
avasopasem on radiation-induced OM in patients with head and neck
cancer. In Galera’s 223-patient, double-blind, randomized,
placebo-controlled Phase 2b trial in patients with locally advanced
head and neck cancer receiving concurrent radiation therapy,
avasopasem produced a statistically significant reduction in
duration of severe oral mucositis (SOM) from 19 days to 1.5 days
(92 percent) in the 90 mg treatment arm. Avasopasem also
demonstrated clinically meaningful reductions in SOM incidence
through completion of radiation by 34 percent and in the severity
of OM (incidence of Grade 4 OM) by 47 percent in the 90 mg
treatment arm. The overall adverse event profile of avasopasem in
the Phase 2b trial was similar to that of placebo and consistent
with the known adverse effects of chemoradiation, with reductions
of blood cell counts, particularly low lymphocyte counts, the most
prominent adverse effects. Adverse events considered attributable
to avasopasem were limited to mild, transient postural
light-headedness or decreased blood pressure. Patients were
followed for two years after enrollment and showed no difference in
tumor outcomes between active and control, consistent with
expectations for combinations with intensity-modulated radiation
therapy (IMRT)/cisplatin, suggesting that the efficacy of the
chemoradiation therapy was not compromised.
Avasopasem is also currently being studied in a Phase 2a trial
for its potential to reduce the incidence of radiation-induced
esophagitis in patients with lung cancer (NCT04225026, available
at clinicaltrials.gov); and a pilot Phase 1/2 trial
(NCT03340974, available at clinicaltrials.gov) in combination
with stereotactic body radiation therapy (SBRT) in patients with
locally advanced pancreatic cancer.
The U.S. Food and Drug Administration granted Fast
Track and Breakthrough Therapy designations to avasopasem for the
reduction of SOM induced by radiotherapy.
About Galera Therapeutics
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on developing and commercializing a pipeline of
novel, proprietary therapeutics that have the potential to
transform radiotherapy in cancer. Galera’s lead product candidate
is avasopasem manganese (GC4419), a highly selective small molecule
superoxide dismutase (SOD) mimetic initially being developed for
the reduction of radiation-induced severe oral mucositis (SOM).
Avasopasem is being studied in the Phase 3 ROMAN trial for its
ability to reduce the incidence and severity of SOM induced by
radiotherapy in patients with locally advanced head and neck
cancer, its lead indication. It is also being studied in a Phase 2a
trial for its ability to reduce the incidence of esophagitis
induced by radiotherapy in patients with lung cancer and in a pilot
Phase 1/2 trial in combination with stereotactic body radiation
therapy (SBRT) in patients with locally advanced pancreatic cancer.
The FDA granted Fast Track and Breakthrough Therapy designations to
avasopasem for the reduction of SOM induced by radiotherapy. Galera
is developing a second product candidate, GC4711, for SBRT which
successfully completed Phase 1 trials in healthy volunteers. Galera
is headquartered in Malvern, PA. For more information, please visit
www.galeratx.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without limitation statements
regarding the potential, efficacy, and regulatory and clinical
development of Galera’s product candidates, and plans and timing
for the release of data from clinical trials. These forward-looking
statements are based on management’s current expectations. These
statements are neither promises nor guarantees, but involve known
and unknown risks, uncertainties and other important factors that
may cause Galera’s actual results, performance or achievements to
be materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, the following: Galera’s
limited operating history; anticipating continued losses for the
foreseeable future; needing substantial funding and the ability to
raise capital; Galera’s dependence on avasopasem manganese
(GC4419); uncertainties inherent in the conduct of clinical trials;
difficulties or delays enrolling patients in clinical trials; the
FDA’s acceptance of data from clinical trials outside the United
States; undesirable side effects from Galera’s product candidates;
risks relating to the regulatory approval process; failure to
capitalize on more profitable product candidates or indications;
ability to receive Breakthrough Therapy Designation or Fast Track
Designation for product candidates; failure to obtain regulatory
approval of product candidates in the United States or other
jurisdictions; ongoing regulatory obligations and continued
regulatory review; risks related to commercialization; risks
related to competition; ability to retain key employees and manage
growth; risks related to intellectual property; inability to
maintain collaborations or the failure of these collaborations;
Galera’s reliance on third parties; the possibility of system
failures or security breaches; liability related to the privacy of
health information obtained from clinical trials and product
liability lawsuits; unfavorable pricing regulations, third-party
reimbursement practices or healthcare reform initiatives;
environmental, health and safety laws and regulations; the impact
of the COVID-19 pandemic on Galera’s business and operations,
including preclinical studies and clinical trials, and general
economic conditions; risks related to ownership of Galera’s common
stock; and significant costs as a result of operating as a public
company. These and other important factors discussed under the
caption “Risk Factors” in Galera’s Quarterly Report on Form 10-Q
for the quarterly period ended March 31, 2020 filed with the U.S.
Securities and Exchange Commission (SEC), Annual Report on Form
10-K for the year ended December 31, 2019 and Galera’s other
filings with the SEC could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Any forward-looking statements speak
only as of the date of this press release and are based on
information available to Galera as of the date of this release, and
Galera assumes no obligation to, and does not intend to, update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Investor Contacts:Christopher DegnanGalera
Therapeutics, Inc.610-725-1500cdegnan@galeratx.com
Jennifer PorcelliSolebury
Trout646-378-2962jporcelli@soleburytrout.com
Media Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
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