Kintara Announces First European Site Activation in Switzerland in GCAR Phase 2/3 Clinical Trial for Glioblastoma

Rhea-AI Summary

Kintara Therapeutics (Nasdaq: KTRA) announced the activation of its first European site at University Hospital Zurich for the VAL-083 treatment arm in the GBM AGILE Phase 2/3 clinical trial for glioblastoma. This trial is currently underway at 44 sites in the U.S. and Canada, aiming to enroll 150-200 patients. The GBM AGILE study is designed to rapidly identify effective therapies through a seamless Phase 2/3 design, enhancing the potential for expedited FDA approvals. Kintara's VAL-083 demonstrates significant clinical activity against various solid tumors.

Positive

• Activation of the first European site for the VAL-083 treatment in the GBM AGILE trial.
• Total of 44 active clinical trial sites in the U.S. and Canada, with plans to expand to 65 worldwide.
• Kintara's participation in the GBM AGILE trial enhances chances for rapid FDA approvals.

Negative

• None.

SAN DIEGO, May 27, 2022 /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 that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma (GBM), titled Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE), has activated its first European site, University Hospital Zurich in Zurich, Switzerland.

GBM AGILE is currently active at 44 clinical sites in the United States and Canada as of May 26, 2022.

GBM AGILE is a patient-centered, Phase 2/3 adaptive platform trial evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Since January 2021, GCAR has accelerated the pace of clinical site activation with increased awareness in the medical community of Kintara's arm of the study. GCAR plans to enroll 150-200 patients in the Kintara arm of the study at over 40 sites in the U.S. and Canada with potential to increase this total to 65 clinical trial centers worldwide.

"This first European clinical site for the Kintara treatment arm of the GBM AGILE study joins 44 active sites in the U.S. and Canada," stated Timothy Cloughesy, M.D., Global Principal Investigator for the GBM AGILE study and Professor of the Neurology and Molecular and Medical Pharmacology program at the University of California, Los Angeles. "We are pleased with the reception we are receiving internationally, and this milestone provides us with continued confidence in the ability of GCAR's GBM AGILE platform trial to materially accelerate the clinical development timelines for companies."

"We continue to see an accelerated pace for which our treatment arm is being executed in the study," commented Robert E. Hoffman, Kintara's President and Chief Executive Officer. "We are also observing GCAR's exceptional clinical trial execution capabilities, which were among the aspects that drew us to participate in this highly efficient registrational study. This achievement provides continued excitement as this study progresses."

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with GBM through response adaptive randomization and a seamless Phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol allowing multiple therapies, or combinations of therapies, from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE may be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.

ABOUT KINTARA

Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are 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 National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently advancing VAL-083 in the GBM AGILE study to support the development and commercialization of VAL-083 in GBM.

Kintara is also advancing its 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 to date of 80% complete responses of CMBC evaluable lesions, and with 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, 2021, 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

FAQ

What is the purpose of the GBM AGILE trial for Kintara (KTRA)?

The GBM AGILE trial aims to evaluate the effectiveness of multiple therapies, including Kintara's VAL-083, for patients with glioblastoma.

When was the first European site activated for Kintara's GBM AGILE trial?

The first European site at University Hospital Zurich was activated on May 27, 2022.

How many patients does Kintara expect to enroll in the GBM AGILE study?

Kintara expects to enroll between 150-200 patients in its arm of the GBM AGILE study.

What is the significance of the GBM AGILE trial's design?

The trial uses a seamless Phase 2/3 design, allowing for rapid identification and confirmation of effective therapies, potentially accelerating FDA approval processes.