Kintara Therapeutics Announces Initiation of REM-001 Clinical Trial for the Treatment of Cutaneous Metastatic Breast Cancer
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Insights
The initiation of a 15-patient open label clinical trial by Kintara Therapeutics to evaluate REM-001 in CMBC patients represents a significant step in the development of novel cancer treatments. REM-001, as a second-generation photodynamic therapy (PDT), offers a potentially advantageous approach due to its targeted mechanism of action, which involves the activation of a photosensitizer by specific wavelengths of light to destroy cancer cells. The reported 80% complete response rate in previous trials suggests a high efficacy of REM-001, although these findings must be validated in larger, controlled studies.
From a medical standpoint, the primary endpoint of Best Overall Objective Response Rate (bORR) is a robust measure of treatment efficacy, focusing on the most meaningful outcomes for patients: complete or partial response to therapy. The trial's design to confirm the planned dose and optimize the study for a subsequent Phase 3 trial is crucial, as dose optimization can lead to improved patient outcomes and reduced toxicity. If successful, REM-001 could fill an important gap in the treatment of CMBC, a condition with currently limited options.
The support from the National Institutes of Health (NIH) in the form of a $2.0 million SBIR grant is a testament to the potential of REM-001's clinical utility. This funding not only underscores the therapy's promise but also mitigates financial risk for Kintara Therapeutics, allowing the company to allocate resources efficiently. The Fast Track Designation by the FDA is indicative of the agency's recognition of REM-001 as a treatment for a serious condition with the potential to address an unmet medical need.
From a research perspective, the trial's open label design will provide immediate insight into the drug's efficacy and safety profile, although it may also introduce biases that are typically controlled for in blinded studies. The trial's outcome will have implications for the company's valuation, as positive results could lead to increased investor confidence and potentially expedite the drug's path to market, assuming subsequent trials are successful.
Considering the estimated prevalence of CMBC in the United States, with potentially over 40,000 cases annually, the market opportunity for REM-001 is significant. The unmet need in this patient population represents a considerable commercial potential for Kintara Therapeutics should REM-001 be approved. Furthermore, the company's strategic positioning in the oncology space could be strengthened by a successful trial outcome, potentially leading to collaborations or licensing agreements.
However, the impact on the stock market will depend on the trial's results and subsequent investor perception. Positive data could lead to stock price appreciation, while any setbacks might have the opposite effect. Long-term implications for stakeholders include the potential for revenue growth upon successful commercialization and the possibility of REM-001 becoming a standard of care for CMBC, subject to regulatory approval and adoption by the medical community.
- 15-patient Open Label Study to Confirm Planned Dose and Optimized Study Design Leading to a Phase 3 Clinical Trial in 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
"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
"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
ABOUT KINTARA
Located in
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
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
FAQ
What is the purpose of the 15-patient clinical trial announced by Kintara Therapeutics (KTRA)?
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What grant did Kintara receive to support the clinical development of REM-001?
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