SAN DIEGO, March 27, 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 expansion of the
inclusion criteria in the open label 15- patient REM-001 study in
cutaneous metastatic breast cancer (CMBC) to include patients
receiving pembrolizumab (KEYTRUDA®) for at least three months at
screening.
CMBC patients are being screened and dosed in the 15-patient
study which 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. The majority of the costs
to run this study will be covered by the $2.0 million Small Business Innovation Research
(SBIR) grant Kintara was awarded from the National Institutes of
Health (NIH).
"Expanding the inclusion criteria to include CMBC patients on
pembrolizumab for at least three months at screening is expected to
significantly increase enrollment in our REM-001 study" commented
Robert E. Hoffman, Kintara's
President and Chief Executive Officer. "With a strengthened balance
sheet, we continue to evaluate strategic options with the goal of
maximizing shareholder value."
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