Imaging Biometrics, LLC, a wholly-owned subsidiary of IQ-AI Ltd, is proud to announce that the US Food and Drug Administration (US FDA) has granted it Orphan Drug Designation (ODD) for its gallium maltolate (GaM) medication for treating pediatric glioblastoma multiforme (GBM). This is an exciting breakthrough in groundbreaking research aimed at helping pediatric cancer patients, and it demonstrates the impact of IQ-AI Ltd’s innovative thinking.
In February, the US FDA granted Orphan Drug Designation to IB for adult and pediatric Glioblastoma (GBM), the most common and aggressive form of primary brain tumor. Despite the devastating effects of GBM among both adults and children, there are currently no effective treatments for pediatric cases. The designation, which seeks to pave the way for better therapies and enhanced access to care, is an important step forward in the fight against this life-threatening disease.
In a revolutionary pediatric study, led by Dr. Mona Al-Gizawiy, PhD from the Medical College of Wisconsin (MCW), Oral GaM demonstrated an impressive 2x greater median overall survival compared to the untreated control group.
Presenting the results at the 2023 Society of Neuro Oncology (SNO) Pediatric Conference in Washington, DC, the results of this easy to administer, capsule form of treatment open a new hopeful treatment option for both pediatric and adult patients.
We are delighted that the FDA has granted orphan drug status to GaM for all GBM populations – including paediatric patients! This is a monumental step forward towards providing improved treatments for this life-threatening condition.
IQ-AI CEO Trevor Brown expressed his enthusiasm for this development, stating, “We are very pleased that the FDA has now confirmed that the orphan drug designation for GaM applies to all GBM populations including pediatric patients.”
About Imaging Biometrics® LLC
IQ-AI Limited (LON:IQAI)(OTCQB:IQAIF) subsidiary ACIB is transforming the way clinicians diagnose and treat patients with their innovative quantitative imaging platforms and therapeutics. ACIB offers a unique approach to improve the outcome of patient care, making diagnosis and treatment more efficient and effective.