REG - IQ-AI Limited - Rare Pediatric Disease Designation Granted to GaM

IQ-AIAnnouncement

10/05/2024 08:30

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RNS Number : 9596N  IQ-AI Limited  10 May 2024

May 10, 2024

IQ-AI Ltd

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

 

Imaging Biometrics Announces U.S. FDA Rare Pediatric Disease Designation
Granted to GaM

 

For the Treatment of atypical teratoid rhabdoid tumor ("ATRT")

Further to the announcement made on 8 November 2023, Imaging Biometrics
("IB"), Elm Grove, WI, a wholly owned subsidiary of IQ-AI Ltd (LSE:  IQAI),
today announces that the U.S. Food and Drug Administration (the "FDA") has
granted Rare Pediatric Disease Designation ("RPDD") to IB-003 for the
treatment of ATRT. IB-003 is the Company's lead drug candidate, oral gallium
maltolate ("GaM").

Rare pediatric diseases are defined by the FDA as serious or life threatening
that affect less than 200,000 people under 18 years of age. ATRT is a highly
aggressive tumor that is associated with dismal outcomes. It is well
acknowledged that there are limited treatment options for children with ATRT.

IB-003 has demonstrated promising potential in pre-clinical and clinical
settings for the treatment of multiple brain tumors. As announced on 27 June
2023, a pre-clinical study conducted by Mona Al-Gizawiy, PhD in the laboratory
of Kathleen Schmainda, PhD at the Medical College of Wisconsin, showed ATRT
growth inhibition and a survival benefit from treatment with IB-003.
Specifically, median overall survival for ATRT was 89 days in the control
group and 170 days in the treated group.

If market approval for IB-003 is obtained under this RPDD, IB may qualify for
a priority review voucher ("PRV"). A PRV can be redeemed to obtain priority
review for subsequent marketing applications, or the PRV can be sold or
transferred to another company.

"Receiving this RPDD from the FDA underscores the unmet clinical need for
children with ATRT," said Trevor Brown, CEO of IQ-AI, Ltd. "It is another
critical milestone in our planning and development of IB-003," Mr Brown added.

--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), 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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