Galera Therapeutics Announces Dosing of First Patient in the Phase 1/2 GRECO-1 Clinical Trial of GC4711 in Combination with S...
October 22 2020 - 8:00AM
Galera Therapeutics, Inc. (Nasdaq: GRTX), 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, today announced that
the first patient has been dosed in the Phase 1/2 GRECO-1 clinical
trial of GC4711 in combination with stereotactic body radiation
therapy (SBRT) in patients with non-small cell lung cancer (NSCLC).
GC4711, Galera’s second clinical candidate, is a highly
selective small molecule superoxide dismutase (SOD) mimetic that is
designed to rapidly convert superoxide to hydrogen peroxide and is
being developed specifically for use in combination with SBRT. In
preclinical studies, GC4711, when added to an SBRT regimen,
increased the anti-cancer efficacy of radiotherapy and protected
normal lung tissue.
The trial is supported in part by a recently awarded Small
Business Innovation Research (SBIR) grant from the National
Cancer Institute (NCI) of the National Institutes of Health (NIH)
for the investigation of Galera’s dismutase mimetics in combination
with SBRT for the treatment of lung cancer. The grant was awarded
by the NCI of the NIH under award number 4R44CA206795-02.
“SBRT holds promise to deliver more efficient, targeted and
potent radiotherapy to improve cancer outcomes. This trial builds
on the pilot trial in combination with SBRT in patients with
locally advanced pancreatic cancer and we are eager to embark on
our exploration of the potential of Galera’s GC4711 to enhance the
anti-cancer efficacy of SBRT,” said Mel Sorensen, M.D., President
and CEO of Galera. “We’re grateful for the support provided by the
SBIR grant, which further recognizes the potential of this
combination.”
Following a safety run-in cohort, up to 66 NSCLC patients with
locally advanced disease will receive GC4711 with SBRT or placebo
with SBRT over five consecutive weekdays in the randomized,
double-blind, placebo-controlled Phase 2 portion of the GRECO-1
trial. The goals of this trial are to assess the effects of GC4711
in combination with SBRT on tumor outcomes and lung injury.
Additional information on the trial can be found
on clinicaltrials.gov using the
identifier NCT04476797.
About GC4711
Galera’s product candidate, GC4711, is an investigational,
highly selective small molecule superoxide dismutase (SOD) mimetic
in development specifically for use in combination with
stereotactic body radiation therapy (SBRT). GC4711 is designed to
rapidly convert superoxide to hydrogen peroxide and is being
developed to synergize with SBRT to exploit cancer cells’ increased
sensitivity to hydrogen peroxide to promote cancer cell death. In
preclinical studies, GC4711, when added to an SBRT regimen,
increased the anti-cancer efficacy of radiotherapy at current
doses. GC4711 successfully completed Phase 1a clinical trials in
healthy volunteers, and is currently being studied in a Phase 1/2
trial in combination with SBRT in patients with non-small cell lung
cancer (NSCLC).
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 to assess
its ability to reduce the incidence and severity of SOM induced by
radiotherapy in patients with locally advanced head and neck cancer
(HNC), its lead indication. It is also being studied in a Phase 2a
multi-center trial in Europe assessing the safety of avasopasem in
patients with HNC undergoing standard-of-care radiotherapy, a Phase
2a trial to assess its ability to reduce the incidence of
esophagitis induced by radiotherapy in patients with lung cancer,
and a Phase 2 trial in hospitalized patients who are critically ill
with COVID-19. Enrollment has also been completed in a pilot Phase
1/2 trial of avasopasem 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’s second SOD mimetic product candidate,
GC4711, is initially being developed to augment the anti-cancer
efficacy of radiation and is currently being studied in a Phase 1/2
clinical trial in combination with SBRT in patients with non-small
cell lung cancer. 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, safety, efficacy, and regulatory and
clinical development of Galera’s product candidates, including with
respect to the Phase 1/2 GRECO-1 clinical trial. 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 June 30, 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:Heather Anderson6
Degrees919-827-5539handerson@6degreespr.com
Galera Therapeutics (NASDAQ:GRTX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Galera Therapeutics (NASDAQ:GRTX)
Historical Stock Chart
From Sep 2023 to Sep 2024