Galera Announces Final Results from Pancreatic Cancer Trial Showing Improvements on all Efficacy Parameters
September 08 2021 - 7:00AM
Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage
biopharmaceutical company focused on developing and commercializing
a pipeline of novel, proprietary therapeutic candidates that have
the potential to transform radiotherapy in cancer, today announced
final results from its Phase 1/2 pilot trial of its dismutase
mimetic, GC4419, versus placebo, in patients with unresectable or
borderline resectable locally advanced pancreatic cancer (LAPC),
who are undergoing stereotactic body radiation therapy (SBRT). The
results include a minimum of one year of follow up on all 42
patients enrolled in the trial.
In this proof-of-concept trial, improvements were observed in
overall survival (HR=0.48; 95% CI: 0.20-1.14; p=0.090),
progression-free survival (HR=0.46; 95% CI: 0.22-0.98; p=0.040),
local tumor control (HR=0.30; 95% CI: 0.08-1.10; p=0.055) and time
to distant metastases (HR=0.39; 95% CI: 0.16-0.93; p=0.028). 46% of
patients in the active arm were alive at last follow-up (11 out of
24) compared to 33% in the placebo arm (6 out of 18). As previously
reported, 29% of patients in the active arm achieved a 30% or
greater decrease in primary tumor size (partial response) compared
to 11% of patients in the placebo arm. GC4419 was well tolerated,
with similar rates of early and late adverse events in the active
and placebo arms. For more information related to this trial,
please see the Company’s updated corporate presentation on the
Investors page of Galera’s website at investors.galeratx.com.
“We are very pleased with the survival and tumor outcome
benefits observed in the final analysis of this proof-of-concept
trial,” said Mel Sorensen, M.D., President and CEO of Galera. “The
improvements across multiple efficacy parameters, together with the
safety data, are encouraging and underpin the rationale for our
160-patient blinded, randomized GRECO-2 trial of GC4711 with SBRT
in pancreatic cancer, where the primary endpoint is overall
survival. These are exciting times for Galera as we also look
forward to announcing topline data from our ROMAN Phase 3 trial for
the reduction of severe oral mucositis in patients with head and
neck cancer later this year.”
“We are excited to see the final results from this trial and
enthusiastic to participate in the Phase 2b GRECO-2 trial,” said
Sarah Hoffe, M.D., Section Head of GI Radiation Oncology at H. Lee
Moffitt Cancer Center and Research Institute. “These observed
overall survival rates are particularly encouraging in pancreatic
cancer, as this patient population faces a difficult diagnosis with
high rates of distant metastasis and low rates of cure.”
Galera’s selective dismutase mimetic product candidates are
small molecules being developed to protect normal cells and
sensitize cancer cells to radiotherapy. The Phase 1/2 pilot trial
was a randomized, double-blind, multicenter, placebo-controlled
trial in 42 patients diagnosed with LAPC evaluating the safety and
efficacy of SBRT and the dismutase mimetic, GC4419, compared to
SBRT and placebo. Patients were randomized (1:1) to receive GC4419
or placebo by intravenous infusion one hour prior to SBRT.
GRECO-2 is a randomized, double-blind, placebo-controlled Phase
2b trial evaluating Galera’s second dismutase mimetic product
candidate, GC4711, compared to placebo in patients with LAPC
undergoing SBRT. The trial was initiated in May 2021 and is
expected to enroll approximately 160 patients. The primary endpoint
of the trial is overall survival. Secondary endpoints include
progression-free survival, local tumor control, time to distant
metastases and surgical resection rate, in addition to safety.
About Galera Therapeutics
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on developing and commercializing a pipeline of
novel, proprietary therapeutic candidates that have the potential
to transform radiotherapy in cancer. Galera’s lead product
candidate is avasopasem manganese (avasopasem, or GC4419), a
selective small molecule dismutase mimetic in late-stage
development to reduce the incidence and severity of
radiotherapy-induced severe oral mucositis (SOM) in patients with
head and neck cancer. Avasopasem is also in development for
radiotherapy-induced esophagitis in patients with lung cancer.
Avasopasem has been granted FDA Fast Track and Breakthrough Therapy
designations for the reduction of SOM induced by radiotherapy, with
or without systemic therapy. Galera’s second dismutase mimetic
product candidate, GC4711, is in clinical-stage development to
augment the anti-cancer efficacy of stereotactic body radiation
therapy in patients with non-small cell lung cancer and locally
advanced pancreatic 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: expectations surrounding our growth and the continued
advancement of our product pipeline; the potential, safety,
efficacy, and regulatory and clinical development of Galera’s
product candidates, including the interpretation of the safety and
efficacy results from the Phase 1/2 LAPC pilot trial and whether
such results underpin the rationale for the ongoing GRECO-2 trial;
and plans and timing for the commencement of and the release of
data from Galera’s 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 or maintain 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 Annual Report on Form 10-K for
the year ended December 31, 2020 filed with the U.S. Securities and
Exchange Commission (SEC) 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
William WindhamSolebury
Trout646-378-2946wwindham@soleburytrout.com
Media Contact:Zara LockshinSolebury
Trout646-378-2960zlockshin@soleburytrout.com
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