IQ-AI subsidiary Imaging Biometrics Medical Oncologist and Emeritus Professor at the Medical College of Wisconsin Dr. Christopher Chitambar joined Steve Darling from Proactive to provide an update on the company's oncology-focused drug, oral gallium maltolate, as it nears the end of its Phase 1 clinical trial. This study is designed to treat groups of patients with relapsed glioblastoma brain tumors using varying doses of oral GaM over a minimum period of two months. The primary goals are to evaluate drug toxicity, assess patient tolerance to the treatment, and establish a recommended dose for a Phase 2 clinical trial.
Historically, patients with relapsed glioblastoma experience disease progression within one to six months following relapse. However, the Phase 1 trial yielded promising results, with some patients remaining on treatment without disease progression for over six months. Remarkably, one patient showed no progression for more than a year. The full results of this Phase 1 study are currently being compiled and are expected to be published by spring 2025.
Dr. Chitambar also discussed the preparations for the Phase 2 trial, which the clinical team has already begun defining. This multi-center trial is expected to span approximately three years and will aim to enroll 50-60 patients. The primary endpoint will be overall survival. The ongoing access to the FDA under Fast Track designation will facilitate the identification of intermediate endpoints, potentially compressing the timeline and expediting the approval process. End-of-phase 1 and phase 2 meetings with the FDA are crucial, and the team anticipates scheduling their end-of-phase 1 meeting as the data analysis from Phase 1 nears completion.
This update highlights the significant progress Imaging Biometrics is making in developing a promising treatment for glioblastoma, offering hope for improved outcomes in this challenging area of oncology.
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