Business
IQAI commits to Phase 1 study
IQAI commits to Phase 1 study.
About this update from Imaging Biometrics Limited
[{"type":"text","content":"\n \n \n \n RNS Number : 2686V\n IQ-AI Limited\n 13 April 2021\n \n \n \n \n IQ-AI Ltd\n(\"IQ-AI\" or the \"Company\")\n \n \n \n \n IQAI commits to Phase1 study for drug candidate in the treatment of Glioblastoma (GBM), a grade IV brain tumour\n \n \n \n IQAI (\"the Company\"), subject to relevant approvals, has agreed to finance a Phase 1 clinical trial planned to commence in the Summer to evaluate the safety and efficacy of Gallium Maltolate (GaM) in the treatment of Glioblastoma Multiforme (the \"Clinical Trial\"). In consideration for financing the Clinical Trial, if successful, the Company intends to apply for orphan drug status under the US FDA Orphan Drug Designation Program. This program grants IP protection to therapy to treat a rare disease or condition and, if granted, provides market exclusivity to IQ-AI for seven years post approval. Other territories, such as Europe and Japan, provide 10- and 8-years exclusivity, respectively.\n \n \n Recent pre-clinical animal studies have shown that GaM can significantly reduce the size of tumours within 10 days of treatment [1], consequently the Company believes that it is now appropriate to commence human trials as soon as possible. To this end, an Investigational New Drug (IND) application has been submitted to the US FDA pending approval of a Phase I trial scheduled to begin this summer. The trial is being conducted at the Medical College of Wisconsin (MCW) Cancer Center and is designed primarily to determine the optimal dose that can be administered safely to patients. During the two-year study, investigators will closely monitor the efficacy of GaM in GBM patients. While efficacy is not the primary aim of a Phase I trial, the investigators will monitor the size of the tumour using magnetic resonance imaging (IB Neuro\n ™\n , has special application for GBM diagnosis and follow up) throughout the course of the trial. Given the aggressive growth of GBM, it is possible that the investigators could obtain an early indication of the efficacy of the treatment during the trial. \n \n \n GBM is the most common and aggressive primary brain cancer and has limited treatment options and a dismal prognosis. Current treatment involves maximal surgical resection followed by radiation therapy and chemotherapy (bevacizumab and temozolomide). Sadly, the median survival of patien...