SAN DIEGO, July 1, 2021 /PRNewswire/ -- Kintara
Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the
"Company"), a biopharmaceutical company developing novel cancer
therapies for patients who are failing or are resistant to current
treatment regimens, today announced topline data results from the
recurrent arm of its open-label, Phase 2 clinical study of its lead
compound VAL-083 being conducted at the MD Anderson Cancer Center
(MD Anderson) in Houston, Texas.
The Phase 2 trial is a two-arm, biomarker-driven study testing
VAL-083 in glioblastoma multiforme (GBM) patients who have an
unmethylated promoter of the methylguanine DNA-methyltransferase
(MGMT) gene. The recurrent arm of the study addressed patients who
have been pre-treated with temozolomide prior to disease
recurrence.
The recurrent arm of the trial enrolled 89 patients, with 35
patients (35 efficacy evaluable) initially receiving a dose of
VAL-083 at 40 mg/m2/day, and 54 patients (48 efficacy
evaluable) initially receiving the treatment dose of 30
mg/m2/day on days 1, 2 and 3 of a 21-day cycle. This 30
mg dose corresponds to the dose being studied in the recently
initiated and currently enrolling VAL-083 study arm of the GBM
AGILE study.
Summary of results:
- Median overall survival
(mOS) for the 48 efficacy evaluable patients initially receiving
the treatment dose of 30 mg/m2/day is 8.0 months (95% confidence
interval: CI 5.9-9.9 months). While this is not a head-to-head
trial, historically, lomustine, which is the most commonly used
chemotherapy for these patients, has demonstrated mOS of 7.2
months*
- Consistent with prior
studies, myelosuppression was the most common adverse event. In the
30 mg/m2/day starting dose cohort, five patients experienced a
serious adverse event (SAE) possibly related to VAL-083
- For the 83 efficacy
evaluable patients who have completed at least one cycle of
treatment mOS was 7.5 months (CI 6.1-9.0 months)
"I'm extremely pleased with the outcome of the recurrent arm of
the study as it provided important safety and efficacy data to
support further evaluation of VAL-083 for the treatment of GBM,"
said Saiid Zarrabian, Kintara's
Chief Executive Officer. "The study of VAL-083 continues in GBM
AGILE, an adaptive registration study where it is
currently the only therapeutic agent being evaluated for all three
GBM patient subtypes: newly-diagnosed methylated MGMT,
newly-diagnosed unmethylated MGMT, and recurrent."
Dr. Barbara O'Brien, the
Principal Investigator for the Phase 2 study at MD Anderson added, "These data continue to
support VAL-083's compelling potential as a potent DNA targeting
cytotoxic agent for the treatment of GBM, which remains a deadly
disease with an urgent need for improved treatment options."
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, and 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.
* Wick et al N.Eng.J.Med . 377:1954 1963 (2017)
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,
bifunctional alkylating agent that crosses the blood-brain-barrier
and has 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