SAN DIEGO, June 3, 2021 /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 it has enrolled the final
patient in the adjuvant arm of its ongoing Phase 2 clinical study
of VAL-083 being conducted at the MD Anderson Cancer Center (MD
Anderson). The adjuvant arm of the study investigates
newly-diagnosed patients suffering from glioblastoma multiforme
(GBM) receiving VAL-083 in place of standard of care temozolomide
(TMZ) as adjuvant therapy following surgery and chemoradiation TMZ.
The trial was designed to enroll up to 36 patients to determine
whether treatment with VAL-083 improves overall survival.
The Phase 2 trial is an open-label, two-arm, biomarker-driven
study testing VAL-083 in GBM patients who have an unmethylated
promoter of the methylguanine DNA-methyltransferase (MGMT)
gene. Efficacy is being measured based on overall survival and
progression-free survival. In February
2021, the Company announced the trial's second arm
(recurrent GBM) enrolled its final patient.
"Enrolling the final patient in the adjuvant arm of the Phase 2
study at MD Anderson is yet another important milestone for the
Company as we continue to advance VAL-083 in multiple settings
including the GCAR sponsored GBM AGILE study where we have already
initiated patient recruitment at 15 sites as the only therapeutic
agent currently being evaluated in this adaptive design
registration study for all three GBM patient subtypes;
newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT,
and recurrent," commented Saiid
Zarrabian, Kintara's Chief Executive Officer.
VAL-083 is a small molecule bifunctional alkylating agent
that crosses the blood-brain barrier. VAL-083 is independent of the
MGMT resistance mechanism and has been assessed in over 40 Phase 1
and Phase 2 clinical trials in multiple indications sponsored by
the U.S. National Cancer Institute (NCI). VAL-083 has been
granted Orphan Drug Designation for GBM by the FDA and EMA and has
also been granted Orphan Drug Designations for medulloblastoma and
ovarian cancer by the FDA. In addition, the FDA has granted Fast
Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved
as a cancer chemotherapeutic in China for the treatment of chronic myelogenous
leukemia and lung cancer. VAL-083 has not been approved for any
indications outside of China.
About Kintara
Located in San
Diego, California, Kintara (NASDAQ: KTRA) is dedicated to
the development of novel cancer therapies for patients with rare
unmet medical needs. Kintara is currently developing two Phase
3-ready therapeutics, 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
NCI. Based on Kintara's internal research programs and these prior
NCI-sponsored clinical studies, Kintara is currently conducting
clinical trials to support the development and commercialization of
VAL-083 in GBM.
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 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 of 80% complete responses of CMBC evaluable lesions and 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, 2020, 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