Kintara Activates First European Site for Phase II/III Glioblastoma Trial


Kintara Therapeutics has activated the first European site of the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) Phase II/III registrational clinical trial for the treatment of glioblastoma (GBM).

The first site in Europe was launched at the University Hospital of Zurich in Switzerland.

Called GBM AGILE, the trial is ongoing at 44 clinical centers in the United States and Canada.

The global, patient-centered, adaptive platform trial is evaluating various therapies for patients with newly diagnosed and recurrent GBM.

Performed according to a master protocol, the trial will allow the simultaneous analysis of various therapies, or combinations of treatments, from different pharmaceutical companies.

GCAR intends to enroll nearly 150 to 200 subjects in the Kintara arm of the trial at more than 40 centers in the United States and Canada. This could be extended to a total of 65 sites worldwide.

A small molecule chemotherapy drug from the company, VAL-083 has a novel mechanism of action.

In trials sponsored by the National Cancer Institute (NCI) in the United States, the therapy showed clinical activity against various cancers, including central nervous system, ovarian and other solid tumors.

Based on Kintara’s internal research programs and prior trials, the Company will advance VAL-083 into the GBM AGILE trial to support development and commercialization of the therapy for GBM treatment.

With its new design and operational infrastructure, the results of the GBM AGILE trial could be used as the basis for seeking a new drug application and biologics license application as well as registrations with the FDA and other agencies. health.

Kintara President and CEO Robert Hoffman said, “We continue to see an accelerated pace for which our treatment arm is running in the study.

“We are also seeing GCAR’s exceptional clinical trial execution capabilities, which are among the aspects that prompted us to participate in this highly successful registration study.”

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