Galera Announces Updated Data from its Randomized, Multicenter, Placebo-Controlled Trial in Patients with Pancreatic Cancer
April 28 2021 - 4:01PM
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
updated results from its Phase 1/2 pilot trial of GC4419, versus
placebo, in patients with locally advanced pancreatic cancer (LAPC)
who are undergoing stereotactic body radiation therapy (SBRT). The
updated results, as of this data analysis, include a minimum follow
up of six months on all 42 patients and were consistent with the
positive results reported with a minimum follow up of three months.
The Company plans to report final results from the trial after a
minimum of one year of follow up, expected during the second half
of 2021.
“The data from this trial continue to impress, showing
consistent and durable benefits across multiple measures, including
the most important for the patient, overall survival,” said Mel
Sorensen, M.D., President and CEO of Galera. “These encouraging
results informed the design of our Phase 2b GRECO-2 trial and
underscore our excitement about the potential to make a meaningful
difference for patients with this tough diagnosis.”
As of this data analysis, median overall survival in the
treatment arm was nearly twice as long as observed in the placebo
arm, 20.1 months compared to 10.9 months, respectively. 29% of
patients in the treatment arm achieved a 30% or greater response
(partial response) compared to 11% of patients in the placebo arm.
Positive results were also observed in local tumor control, time to
metastases and progression-free survival. As previously reported,
GC4419 was well tolerated as of this data analysis, with similar
rates of adverse events in the treatment and placebo arms.
“There are limited treatment options for patients with locally
advanced pancreatic cancer and we are continually looking for
innovative approaches,” said Sarah Hoffe, M.D., Section Head of GI
Radiation Oncology at H. Lee Moffitt Cancer Center and Research
Institute. “These pancreatic data are exciting and speak to the
potential emergence of an entirely novel class of cancer
therapeutics for patients.”
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
is 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.
The data from this trial support GRECO-2, a multicenter,
randomized, double-blind, placebo-controlled Phase 2b trial to
evaluate GC4711, Galera's second dismutase mimetic product
candidate, combined with SBRT in patients with LAPC. The primary
endpoint of the Phase 2b trial is overall survival. The Company
expects to initiate patient dosing in GRECO-2 in the first half of
2021, and the trial is expected to enroll approximately 160
patients.
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 (GC4419, also referred to as
avasopasem), a selective small molecule dismutase 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 the EUSOM Phase 2a multi-center trial in Europe
assessing the safety of avasopasem in patients with HNC undergoing
standard-of-care radiotherapy, the AESOP 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. A pilot
Phase 1/2 trial of avasopasem in combination with stereotactic body
radiation therapy (SBRT) in patients with locally advanced
pancreatic cancer (LAPC) has completed enrollment and reported
results, with follow-up ongoing. The FDA granted Fast Track and
Breakthrough Therapy designations to avasopasem for the reduction
of SOM induced by radiotherapy. Galera’s second dismutase mimetic
product candidate, GC4711, is being developed specifically to
augment the anti-cancer efficacy of SBRT, and is currently being
studied in the GRECO-1 Phase 1/2 trial in combination with SBRT in
patients with non-small cell lung cancer. Galera also intends to
initiate the GRECO-2 Phase 2b trial of GC4711 in combination with
SBRT in patients with LAPC. 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; 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
Jennifer PorcelliSolebury
Trout646-378-2962jporcelli@soleburytrout.com
Media Contact:Zara LockshinSolebury
Trout646-378-2960zlockshin@soleburytrout.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