- 15-patient Open Label Study to Confirm
Planned Dose and Optimized Study Design Leading to a Phase 3
Clinical Trial in CMBC Patients -
SAN
DIEGO, Feb. 12, 2024 /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 the initiation of a REM-001
15-patient clinical trial (NCT05374915) in cutaneous metastatic
breast cancer (CMBC) patients.
This open label 15-patient study in CMBC patients is evaluating
REM-001, a second-generation photodynamic therapy (PDT)
photosensitizer agent, and is designed to test the 0.8 mg dose as
well as optimize the study design in advance of a Phase 3 trial
initiation. The primary endpoint in the study is Best Overall
Objective Response Rate (bORR) (complete response or partial
response) of the target treatment fields at any time from treatment
up to, and including, week 24.
In June 2023, Kintara was awarded
a $2.0 million Small Business
Innovation Research (SBIR) grant from the National Institutes of
Health (NIH) to support the clinical development of REM-001 in
CMBC. This grant will cover the majority of the costs to run this
clinical study.
"We are encouraged by the extensive data from prior REM-001
therapy trials supporting its strong efficacy in CMBC patients,
providing us with an opportunity to address a significant unmet
medical need," said Robert E.
Hoffman, President and CEO of Kintara. "With an 80% complete
response rate for evaluable lesions in CMBC patients observed
in previous late-stage clinical trials and the support of the NIH,
along with the FDA's Fast Track Designation, we are confident in
the potential of REM-001 to help CMBC patients."
"CMBC is a devastating disease with limited treatment options
for patients," said Alina Markova, M.D., Section Head, General
Dermatology and Oncodermatology at Memorial Sloan Kettering Cancer
Center and Principal Investigator of the REM-001 15-patient study.
"I am looking forward to testing the therapeutic potential of
REM-001 in this trial and bringing novel therapies to CMBC patients
to improve their quality of life."
Cutaneous metastases can develop with any metastatic cancer but
are believed to occur most frequently in metastatic breast
cancer. A 2003 meta-analysis of over 20,000 metastatic cancer
patients found that 24% of the breast cancer patients included in
the analysis had developed cutaneous metastases, which was the
highest rate of any cancer type. Based on a 2017 analysis,
the current prevalence of metastatic breast cancer in the United States is estimated to be over
168,000. Accordingly, the prevalence of CMBC may be in excess of
40,000 cases annually in the United
States.
ABOUT KINTARA
Located in San Diego,
California, Kintara is dedicated to the development of novel
cancer therapies for patients with unmet medical needs. Kintara
develops therapeutics for clear unmet medical needs with reduced
risk development programs. The Company's lead program is
REM-001 Therapy for cutaneous metastatic breast cancer.
Kintara has 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, which consists of the laser light source, the
light delivery device, and the REM-001 drug product, 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. In CMBC, REM-001 has a clinical efficacy to date
of 80% complete responses of CMBC evaluable lesions and an existing
robust safety database of approximately 1,100 patients across
multiple indications.
For more information, please visit www.kintara.com or
follow us on X 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 Company's REM-001
15-patient clinical trial in CMBC patients. 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 Company's ability to develop, market
and sell products based on its technology; the Company's review of
strategic alternatives; 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; the status of the Company's clinical
trials; the Company's business, research, product development,
regulatory approval, marketing and distribution plans and
strategies; and global unrest. 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, 2023, the
Company's Quarterly Reports on Form 10-Q, and the Company's Current
Reports on Form 8-K.
CONTACTS
Investors:
Robert E. Hoffman
Kintara Therapeutics
rhoffman@kintara.com
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SOURCE Kintara Therapeutics