SAN
DIEGO, Aug. 9, 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 it has received a
Study May Proceed letter from the United States Food and Drug
Administration (FDA) to begin its 15 patient study evaluating
REM-001 Photodynamic Therapy (PDT) for the treatment of Cutaneous
Metastatic Breast Cancer (CMBC). This study is intended to aid in
the design of a planned phase 3 registrational study.
"The FDA's reactivation of our Investigational New Drug
application for REM-001 is an important milestone for Kintara,"
stated Robert E. Hoffman, President and CEO of Kintara. "This
clinical study is part of a broad strategy designed to demonstrate
proof of concept for our Photodynamic Therapy platform in CMBC, an
area of unmet medical need, as well as across other cutaneous
metastatic cancers."
PDT is a treatment that uses light sensitive compounds, or
photosensitizers, that, when exposed to specific wavelengths of
light, act as a catalyst to produce a form of oxygen that induces
local tumor cell death. The planned clinical study is expected to
enroll 15 patients with CMBC that is refractory or not eligible for
radiotherapy or surgery. The study will evaluate cutaneous tumor
response using standardized and calibrated 3D digital
photography.
"We're excited to further explore the potential benefits of this
second-generation photosensitizer, particularly given the unmet
need of CMBC," added Dr. Mario E.
Lacouture, Professor and Director of the Oncodermatology
Program in the Dermatology Service Department of Medicine at
Memorial Sloan Kettering Cancer Center and Chairman of Kintara's
REM-001 Scientific Advisory Board.
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 glioblastoma (GBM)
and REM-001 for 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 Global Coalition for
Adaptive Research registrational phase 2/3 clinical trial titled
Glioblastoma Adaptive Global Innovative Learning Environment (GBM
AGILE) Study to support the development and commercialization
of VAL-083 in GBM.
Kintara is also advancing its proprietary, late-stage PDT
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