SAN
DIEGO, June 15, 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 United States Food
and Drug Administration (FDA) has granted Fast Track Designation
(FTD) to Kintara's VAL-083 for the treatment of patients with
newly-diagnosed unmethylated glioblastoma (GBM).
Fast Track is a process designed to facilitate the development,
and expedite the review of drugs to treat serious conditions and
fill an unmet medical need. Some of the significant benefits of FTD
include:
- Enhanced access to the FDA, including opportunities for more
frequent meetings and written consultation throughout the remaining
development of VAL-083.
- Drugs with FTD are eligible to apply for Accelerated Approval
and Priority Review at the time of a New Drug Application (NDA)
submission, which may result in faster product approval.
- FTD also allows for 'rolling review', whereby Kintara may
submit completed sections of the VAL-083 NDA as they become
available, rather than at the end of development.
"We believe Fast Track Designation is indicative of VAL-083's
potential to improve outcomes for patients with GBM, the most
aggressive form of brain cancer," stated Robert E. Hoffman, President and CEO of Kintara.
"We look forward to announcing top-line data from the international
registrational phase 2/3 GBM AGILE Study around the end of calendar
year 2023. Fast Track Designation allows us to work closely with
the FDA and may expedite our commercial launch of VAL-083, if
approved."
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 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
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 impact of Fast
Track Designation and 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