REG - IQ-AI Limited - Orphan Drug Designation for GaM in Pediatric GBM

IQ-AIAnnouncement

13/07/2023 07:00

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RNS Number : 8411F  IQ-AI Limited  13 July 2023

13 July 2023

IQ-AI Ltd

("IQ-AI" or the "Company")

 

Orphan Drug Designation for GaM in Pediatric GBM

 

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 all
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 benefits in a pre-clinical
study for pediatric GBM. 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.

 

--ENDS-

 

The Directors of the Company accept responsibility for the contents of this
announcement.

 

For further information, please contact:

 

 IQ-AI Ltd

 Trevor Brown/Vinod Kaushal/Brett Skelly/Michael Schmainda

 Tel: 020 7469 0930
 Peterhouse Capital Limited (Financial Adviser and Broker)

 Lucy Williams/Heena Karani

 Tel: 020 7220 9797

 

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
(http://www.imagingbiometrics.com/) . Follow IB on Twitter, @IQAI_IB.

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