SAN
DIEGO, May 27, 2022 /PRNewswire/ -- Kintara
Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the
"Company"), a biopharmaceutical company focused on the development
of new solid tumor cancer therapies, today announced that the
VAL-083 treatment arm in the Global Coalition for Adaptive Research
(GCAR) registrational Phase 2/3 clinical trial for glioblastoma
(GBM), titled Glioblastoma Adaptive Global Innovative Learning
Environment (GBM AGILE), has activated its first European site,
University Hospital Zurich in Zurich,
Switzerland.
GBM AGILE is currently active at 44 clinical sites in
the United States and Canada as of May 26,
2022.
GBM AGILE is a patient-centered, Phase 2/3 adaptive platform
trial evaluating multiple therapies for patients with
newly-diagnosed and recurrent GBM. Since January 2021, GCAR has accelerated the pace of
clinical site activation with increased awareness in the medical
community of Kintara's arm of the study. GCAR plans to enroll
150-200 patients in the Kintara arm of the study at over 40 sites
in the U.S. and Canada with
potential to increase this total to 65 clinical trial centers
worldwide.
"This first European clinical site for the Kintara treatment arm
of the GBM AGILE study joins 44 active sites in the U.S. and
Canada," stated Timothy Cloughesy, M.D., Global Principal
Investigator for the GBM AGILE study and Professor of the Neurology
and Molecular and Medical Pharmacology program at the University of California, Los Angeles. "We are
pleased with the reception we are receiving internationally, and
this milestone provides us with continued confidence in the ability
of GCAR's GBM AGILE platform trial to materially accelerate the
clinical development timelines for companies."
"We continue to see an accelerated pace for which our treatment
arm is being executed in the study," commented Robert E. Hoffman, Kintara's President and Chief
Executive Officer. "We are also observing GCAR's exceptional
clinical trial execution capabilities, which were among the aspects
that drew us to participate in this highly efficient registrational
study. This achievement provides continued excitement as this study
progresses."
GBM AGILE is an international, innovative platform trial
designed to more rapidly identify and confirm effective therapies
for patients with GBM through response adaptive randomization and a
seamless Phase 2/3 design. The trial, conceived by over 130 key
opinion leaders, is conducted under a master protocol allowing
multiple therapies, or combinations of therapies, from different
pharmaceutical partners to be evaluated simultaneously. With its
innovative design and efficient operational infrastructure, data
from GBM AGILE may be used as the foundation for a new drug
application and biologics license application submissions and
registrations to the FDA and other health authorities.
ABOUT KINTARA
Located in San Diego,
California, Kintara is dedicated to the development of novel
cancer therapies for patients with unmet medical needs. Kintara is
developing two late-stage, Phase 3-ready therapeutics for clear
unmet medical needs with reduced risk development programs. The two
programs are VAL-083 for GBM and REM-001 for Cutaneous Metastatic
Breast Cancer (CMBC).
VAL-083 is a "first-in-class", small-molecule
chemotherapeutic with a novel mechanism of action that has
demonstrated clinical activity against a range of cancers,
including central nervous system, ovarian and other solid tumors
(e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical
trials sponsored by the National Cancer Institute (NCI). Based on
Kintara's internal research programs and these
prior NCI-sponsored clinical studies, Kintara is
currently advancing VAL-083 in the GBM AGILE study to support the
development and commercialization of VAL-083 in GBM.
Kintara is also advancing its proprietary, late-stage
photodynamic therapy platform that holds promise as a localized
cutaneous, or visceral, tumor treatment as well as in other
potential indications. REM-001 therapy has been previously
studied in four Phase 2/3 clinical trials in patients with CMBC who
had previously received chemotherapy and/or failed radiation
therapy. With clinical efficacy to date of 80% complete responses
of CMBC evaluable lesions, and with an existing robust safety
database of approximately 1,100 patients across multiple
indications, Kintara is advancing the REM-001 CMBC
program to late-stage pivotal testing.
For more information, please visit www.kintara.com or
follow us on Twitter
at @Kintara_Thera, Facebook and Linkedin.
SAFE HARBOR STATEMENT
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995, including statements regarding the status of the
Company's clinical trials and the GBM AGILE study. Any
forward-looking statements contained herein are based on current
expectations but are subject to a number of risks and
uncertainties. The factors that could cause actual future results
to differ materially from current expectations include, but are not
limited to, risks and uncertainties relating to the impact of the
COVID-19 pandemic on the Company's operations and clinical trials;
the Company's ability to develop, market and sell products based on
its technology; the expected benefits and efficacy of the Company's
products and technology; the availability of substantial additional
funding for the Company to continue its operations and to conduct
research and development, clinical studies and future product
commercialization; and, the Company's business, research, product
development, regulatory approval, marketing and distribution plans
and strategies. These and other factors are identified and
described in more detail in the Company's filings with the SEC,
including the Company's Annual Report on Form 10-K for the year
ended June 30, 2021, the Company's
Quarterly Reports on Form 10-Q, and the Company's Current Reports
on Form 8-K.
CONTACTS:
Investors:
CORE IR
516-222-2560
ir@coreir.com
Media:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com
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SOURCE Kintara Therapeutics