REG - IQ-AI Limited - IB Announces Expanded Access Program for GaM

IQ-AIAnnouncement

02/05/2024 13:00

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RNS Number : 0442N  IQ-AI Limited  02 May 2024

IQ-AI Ltd

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

 

Imaging Biometrics Announces Expanded Access Program for Oral Gallium Maltolate

Company initiating program based on phase 1 tolerability and safety results

 

Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI Ltd (LSE:
IQAI), has received FDA approval to proceed with an Expanded Access Program
(EAP) for its lead therapeutic candidate, gallium maltolate (GaM). The EAP is
for adult patients with recurrent/refractory glioblastoma who meet certain
program eligibility criteria.

 

EAPs are regulated by the Food and Drug Administration (FDA) and allow
patients who are otherwise not eligible for clinical trials to have access to
potential therapies ahead of regulatory approval. In the case of a serious
condition or life-threatening disease for which there are no viable treatment
options, and where a clinical trial is not an option for a patient, a doctor
can prescribe an unapproved therapy through an FDA EAP.

 

"Considering the dismal prognosis of high-grade brain tumors, and following
the encouraging safety profile and tolerance demonstrated in the ongoing phase
1 clinical trial at the Medical College of Wisconsin, we believe it is
appropriate to initiate an EAP.  This will enable more patients to
potentially benefit from the treatment," 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), 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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