Imaging Biometrics, LLC (IB) , a wholly-owned subsidiary of IQ-AI Ltd (LSE:IQAI)(OTCQB:IQAIF) , today announced the U.S. Food and Drug Administration (US FDA) has granted Orphan Drug Designation (ODD) for gallium maltolate (GaM) for the treatment of pediatric glioblastoma multiforme (GBM).
MILWAUKEE, WI / ACCESSWIRE / July 13, 2023 / Imaging Biometrics, LLC (IB), a wholly-owned subsidiary of IQ-AI Ltd (LSE:IQAI)(OTCQB:IQAIF), today announced the U.S. Food and Drug Administration (US FDA) has granted Orphan Drug Designation (ODD) for gallium maltolate (GaM) for the treatment of pediatric glioblastoma multiforme (GBM).
In February, IB was granted Orphan Drug Designation for adult GBM. The US FDA has since confirmed that the designation granted in February applies to both adult and pediatric GBM patients. GBM is the most common and aggressive primary brain tumor in adults and children. There are currently no effective treatments for pediatric glioblastoma.
Oral GaM recently demonstrated significant survival benefit in a pre-clinical study for pediatric GBM. The results of the study, performed in the lab of Dr. Kathleen Schmainda, PhD and led by Dr. Mona Al-Gizawiy, PhD from the Medical College of Wisconsin (MCW), were presented at the 2023 Society of Neuro Oncology (SNO) Pediatric Conference in Washington, DC last month. Median overall survival was more than 2x longer in the group treated with GaM compared to the untreated controls. These promising results, coupled with the easy administration by capsule, make this a very attractive potential treatment option for both pediatric and adult patients.
“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,” said Trevor Brown, CEO of IQ-AI.
About Imaging Biometrics® LLC: IB is a wholly-owned subsidiary of IQ-AI Limited, (LON:IQAI)(OTCQB:IQAIF), and focuses on delivering quantitative imaging platforms and therapeutics that transform how clinicians diagnose and treat patients more efficiently and effectively. For more information about Imaging Biometrics, visit the company’s website at www.imagingbiometrics.com. Follow IB on Twitter, @IQAI_IB.
Contact Information:
Michael Schmainda
Tel: 262-439-8252
SOURCE: IQ AI Ltd.
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