- VAL-083 Did Not Perform Better Than Current
Standards of Care -
- Company Suspending Development of VAL-083,
Shifting Focus to REM-001 Program and Other Strategic Opportunities
-
SAN
DIEGO, Oct. 31, 2023 /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
preliminary topline results from the Glioblastoma Adaptive Global
Innovative Learning Environment (GBM AGILE) study showed that
VAL-083 did not perform better than the current standards of care
in glioblastoma. These topline results included preliminary safety
data for VAL-083 that was similar to that of the current standards
of care used to treat glioblastoma. With this study outcome,
Kintara is suspending the development of VAL-083 and turning its
focus to its second program, REM-001. In addition to focusing on
its REM-001 program, Kintara will evaluate a wide range of
strategic options aimed at potentially maximizing shareholder
value.
"Glioblastoma represents a high unmet medical need, and patients
with this disease have very few treatment options," said
Robert E. Hoffman, President and
Chief Executive Officer of Kintara. "We are very disappointed that
the VAL-083 GBM AGILE Study preliminary results do not support
continued development efforts to give patients additional treatment
options. We sincerely appreciate the exceptional support from
patients and their families as well as patient advocates,
physicians and our employees who have been committed to the
rigorous study of VAL-083. As we shift priorities, we look forward
to enrolling our first patient in our 15-patient study of REM-001
in cutaneous metastatic breast cancer (CMBC). Additionally, we will
conduct a thorough review of potential strategic opportunities for
us to maximize shareholder value in the Company."
"GBM AGILE is a rigorous mechanism for us to efficiently
evaluate investigational drugs in a well-controlled, randomized
setting," said Meredith Buxton, CEO
and President of Global Coalition of Adaptive Research, Sponsor of
GBM AGILE. "While we are disappointed that the preliminary
results for VAL-083 did not show benefit over standard of care, GBM
AGILE is operating as designed and we await final data for VAL-083
in 2024 to better understand if there are possible pathways for
further development."
All development activities and related costs for VAL-083 will be
suspended while the Company awaits the full dataset from the GBM
AGILE Study which is expected at the end of the first
quarter/beginning of second quarter of calendar year 2024. At such
time Kintara will analyze the full results as it seeks to maximize
the value of the VAL-083 asset.
Kintara expects to enroll the first subject in a 15-patient CMBC
study around the end of calendar year 2023. The Company was
recently awarded a $2 million grant
from the National Institutes of Health (NIH) which is expected to
cover the majority of the cost to run the CMBC study. In
November 2022, the United States Food
and Drug Administration (FDA) granted Fast Track Designation (FTD)
to Kintara's REM-001 Therapy for the treatment of patients with
CMBC.
REM-001 is a 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, which consists of the laser light source, the light
delivery device, and the REM-001 drug product, 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. In CMBC, REM-001 has a clinical efficacy to date of 80%
complete responses of CMBC evaluable lesions and an existing robust
safety database of approximately 1,100 patients across multiple
indications.
ABOUT KINTARA
Located in San Diego,
California, Kintara is dedicated to the development of novel
cancer therapies for patients with unmet medical needs and reduced
development risk. Kintara's focus is the development of REM-001 as
a treatment for CMBC.
For more information, please visit www.kintara.com or
follow us on X (formerly 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, the topline results of the GBM AGILE
Study and the Company's review
of strategic alternatives. 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 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; the
Company's business, research, product development, regulatory
approval, marketing and distribution plans and strategies; and
global unrest. 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, 2023, the Company's
Quarterly Reports on Form 10-Q, and the Company's Current Reports
on Form 8-K.
CONTACTS
Robert E.
Hoffman
Kintara
Therapeutics
rhoffman@kintara.com
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SOURCE Kintara Therapeutics