SAN DIEGO, Feb. 17, 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 recurrent arm of its ongoing Phase 2 clinical study
of VAL-083 being conducted at the MD Anderson Cancer Center (MD
Anderson). The recurrent arm of the study addresses patients
suffering from glioblastoma multiforme (GBM) who have been
pre-treated with temozolomide (TMZ) prior to disease
recurrence. The trial was designed to enroll up to 83 patients (35
patients at 40 mg/m2/day and 48 patients at
30mg/m2/day) to determine whether treatment with VAL-083
improves overall survival.
"Given the urgent need for improved treatment options for this
deadly disease, we are pleased to have reached the very important
milestone of full enrollment in the recurrent arm of this Phase 2
clinical study," commented Saiid
Zarrabian, Kintara's Chief Executive Officer. "We would like
to thank our patients, their families, and MD Anderson for their
participation and continued support for this arm of the trial and
of course, for our adjuvant study arm as well. Moving forward, we
anticipate reporting topline results from the recurrent arm in the
second quarter of calendar 2021."
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 addition to the recurrent arm, there
is a second trial arm that is enrolling up to 36 newly-diagnosed
patients who have undergone surgery and chemoradiation with TMZ,
and who are receiving VAL-083 in place of standard of care TMZ for
adjuvant therapy. In November 2020,
the Company provided a clinical update on both arms of the study.
For the recurrent arm, median overall survival (mOS) for the 77
efficacy evaluable patients who completed at least one cycle of
treatment was 7.6 months (confidence interval: CI 6.4-10.6 months).
Additionally, for the 43 efficacy evaluable patients initially
receiving the 30 mg/m2/day dose that is being evaluated
in the Global Coalition for Adaptive Research (GCAR) GBM AGILE
(Glioblastoma Adaptive Global Innovative Learning Environment)
registrational study, mOS was 8.5 months (CI 6.8-13.7 months). In
the adjuvant therapy arm of the study, median progression-free
survival (PFS) was 10.0 months (CI 7.6-10.8). Consistent with prior
studies, myelosuppression was the most common adverse event with
VAL-083 in both the recurrent GBM and adjuvant treatment setting.
In the 30 mg/m2/day starting dose cohort (the planned
dose for the GBM AGILE pivotal study) three subjects experienced a
serious adverse event (SAE) possibly related to VAL-083 in the
recurrent group and one patient experienced a possibly drug-related
SAE in the adjuvant group.
VAL-083 is a "first-in-class," 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). Published pre-clinical and clinical data indicate
that VAL-083 has activity against a range of tumor types, including
lung, brain, cervical, ovarian tumors and hematologic (blood)
cancers. 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