Galera to Present at 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting
September 26 2022 - 07:00AM
GlobeNewswire Inc.
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
tumor outcomes data from its Phase 3 ROMAN trial of avasopasem for
severe oral mucositis (SOM) and final data from its Phase 2 AESOP
trial of avasopasem for chemoradiotherapy-induced esophagitis will
be highlighted in two presentations at the upcoming 2022 American
Society for Radiation Oncology (ASTRO) Annual Meeting, taking place
October 23-26, 2022 in San Antonio, Texas. Additionally, poster
presentations will highlight the Phase 2 EUSOM trial of avasopasem
for SOM in Europe and the ongoing GRECO-1 trial of rucosopasem for
non-small cell lung cancer.
Presentation Details
Title: Tumor Outcomes for ROMAN: Phase 3 Trial
of Avasopasem Manganese (GC4419) for Severe Oral Mucositis (SOM) in
Patients Receiving Chemoradiotherapy (CRT) for Locally Advanced
Head and Neck Cancer (LAHNC)Abstract Number:
280Presenter: Carryn M. Anderson, M.D., University
of Iowa Hospitals & Clinics Session Title:
H&N 3 - Toxicity Mitigation and HPV-Unrelated Head and Neck
Cancer - Life Beyond De-IntensificationSession Date and
Time: Wednesday, October 26, 2022 | 12:40 p.m.
CDTSession Location: Henry B. Gonzalez Convention
Center, Room 214
Title: AESOP: Phase 2 Open-Label Trial of
Avasopasem Manganese (GC4419) for Reduction of Esophagitis in
Patients Receiving Chemoradiotherapy for Nonmetastatic Lung
CancerAbstract Number:
1124Presenter: Bryan G. Allen, M.D., Ph.D.,
University of Iowa Hospitals & Clinics Session
Title: Lung 3 - Optimizing Radiation Dose, Volume,
and Concomitant Systemic AgentsSession Date and
Time: Wednesday, October 26, 2022 | 10:50 a.m.
CDTSession Location: Henry B. Gonzalez Convention
Center, Room 303
Poster Q&A Details
Title: GRECO-1: Phase 1/2 Study of Stereotactic
Body Radiation Therapy (SBRT) with or without Rucosopasem (GC4711)
for Early Stage, Peripheral or Centrally Located Non-Small Cell
Lung Cancer (NSCLC)Abstract Number:
2841Presenter: Puneeth Iyengar, M.D., Ph.D., UT
Southwestern Medical CenterSession Title: Poster
Q&A 01 - Lung Cancer and DEIHSession Date and
Time: Sunday, October 23, 2022 | 4:45 p.m.
CDTSession Location: Henry B. Gonzalez Convention
Center, Exhibit Hall 1
Title: EUSOM: Phase 2 Trial of Avasopasem
Manganese (GC4419) for Oral Mucositis in Patients Receiving
Chemoradiotherapy for Locally Advanced, Nonmetastatic Head and Neck
CancerAbstract Number:
2687Presenter: Jordi Giralt, M.D., Ph.D., Vall
d'Hebron University HospitalSession Title: Poster
Q&A 09 - Head & Neck Cancer and Health Services
ResearchSession Date and Time: Wednesday, October
26, 2022 | 10:30 a.m. CDTSession Location: Henry
B. Gonzalez Convention Center, Exhibit Hall 1
The titles of the abstracts are currently available in the ASTRO
digital program, with the full abstracts available on Friday,
October 21, 2022, at 5 p.m. CDT.
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 selective dismutase
mimetic product candidate avasopasem manganese (GC4419, also
referred to as avasopasem) is being evaluated for
radiotherapy-induced toxicities. The Company’s second product
candidate, rucosopasem manganese (GC4711, also referred to as
rucosopasem), 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: the expectations surrounding the continued advancement
of Galera’s product pipeline; the potential safety and efficacy of
Galera’s product candidates and their regulatory and clinical
development; the Company’s ability to achieve its goal of
transforming radiotherapy in cancer treatment with its selective
dismutase mimetics; and the potential of rucosopasem to augment the
anti-cancer efficacy of SBRT in patients with NSCLC and LAPC. 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; the possibility of Galera’s
common stock being delisted from The Nasdaq Global Market; 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, 2021 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 Strategic
Communications646-378-2946wwindham@soleburystrat.com
Media Contact:Zara LockshinSolebury Strategic
Communications330-417-6250zlockshin@soleburystrat.com
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