Galera Announces Completion of Enrollment in Pivotal 455-Patient Phase 3 Trial of Avasopasem for Severe Oral Mucositis
June 28 2021 - 7:00AM
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
completion of enrollment in its pivotal Phase 3 ROMAN trial of
avasopasem manganese (avasopasem) for the treatment of severe oral
mucositis (SOM) in patients with locally advanced head and neck
cancer (HNC) undergoing standard-of-care radiotherapy. This
achievement has triggered a $37.5 million milestone payment from
funds managed by Blackstone Life Sciences to Galera under the
amended royalty agreement.
“We are extremely pleased to announce completion of enrollment
of the pivotal ROMAN trial, laying the groundwork for the potential
regulatory approval and commercialization of avasopasem, our lead
dismutase mimetic product candidate,” said Mel Sorensen, M.D.,
Galera’s President and CEO. “About 65% of patients diagnosed with
HNC will receive standard-of-care chemoradiotherapy and
approximately 70% of those patients will develop SOM. Radiation
oncologists describe SOM — which can lead to the inability to eat
and drink in addition to causing severe pain — as the most
burdensome toxicity patients can face. With no approved product to
treat SOM, we are eager to report results in the second half of
2021 for this potentially transformative therapy.”
The ROMAN trial is a randomized, double-blind,
placebo-controlled trial in 455 patients designed to evaluate the
ability of avasopasem to reduce radiation-induced SOM in patients
with locally advanced HNC, receiving seven weeks of
standard-of-care radiotherapy plus cisplatin. Patients were
randomized to one of the two treatment groups (3:2) to receive 90
mg of avasopasem or placebo by infusion on the days they receive
their radiation treatment. The primary endpoint of the trial is the
reduction in the incidence of SOM through the radiotherapy period.
Secondary endpoints include the reduction in the severity of SOM
and the number of days patients experience SOM.
The FDA has granted Fast Track and Breakthrough Therapy
Designation to avasopasem for the reduction of SOM induced by
radiotherapy, with or without systemic therapy.
About Oral Mucositis
Oral mucositis is a side effect of radiation therapy
characterized by severe pain, inflammation, ulceration and bleeding
of the mouth. In patients with head and neck cancer, radiotherapy
is a mainstay of treatment. Approximately 70 percent of patients
receiving radiotherapy for head and neck cancer develop severe oral
mucositis (SOM), defined by the inability to eat solid food (Grade
3) or drink liquids (Grade 4). The impact on patients who develop
SOM is substantial, particularly when hospitalization and/or
surgical placement of PEG tubes to maintain nutrition and hydration
are required. SOM can adversely affect cancer treatment outcomes by
causing interruptions in radiotherapy, which may compromise the
otherwise good prognosis for tumor control in many of these
patients. There is currently no drug approved to prevent or treat
SOM.
About Avasopasem
Galera’s lead product candidate is avasopasem manganese
(avasopasem, or GC4419), a selective small molecule dismutase
mimetic in development for the reduction of radiation-induced
severe oral mucositis (SOM) in patients with locally advanced head
and neck cancer (HNC). In addition to the ongoing pivotal Phase 3
ROMAN trial evaluating avasopasem in SOM patients with locally
advanced HNC, the Company is conducting a Phase 2a trial of
avasopasem assessing its ability to reduce the incidence of
radiation-induced esophagitis in patients with lung cancer as well
as a Phase 1/2 trial assessing its anti-tumor effect when used in
combination with stereotactic body radiation therapy in patients
with locally advanced pancreatic cancer. The FDA has granted Fast
Track and Breakthrough Therapy Designation to avasopasem for the
reduction of SOM induced by radiotherapy, with or without systemic
therapy.
About the Phase 3 ROMAN Trial
The ROMAN trial is a randomized, double-blind,
placebo-controlled trial designed to evaluate the ability of
avasopasem to reduce the incidence and severity of
radiation-induced SOM in patients with locally advanced head and
neck cancer, receiving seven weeks of radiotherapy plus cisplatin.
For more information, please visit
https://clinicaltrials.gov/ct2/show/NCT03689712.
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, including plans for reporting
topline data from the ROMAN trial in the second half of 2021,
potential FDA regulatory approval and the commercial launch of
avasopasem; the potential, safety, efficacy, and regulatory and
clinical development of Galera’s product candidates, including
whether avasopasem could be a potentially transformative therapy
for the treatment of SOM; and expected payments from Blackstone,
including the receipt of the $37.5 million triggered upon
completion of enrollment of the ROMAN 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 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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