REG - IQ-AI Limited - IB Launching an Expanded Access Program for GaM

IQ-AIAnnouncement

10/01/2024 07:00

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RNS Number : 1417Z  IQ-AI Limited  10 January 2024

IQ-AI Ltd

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

Imaging Biometrics Launching an Expanded Access Program for Oral GaM

 

Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI Ltd (LSE:
IQAI, OTCBB: IQAIF), is launching an intermediate population cohort expanded
access program (EAP) for oral gallium maltolate (GaM), subject to FDA
approval. The EAP will be for brain tumor patients located throughout the
United States who are unable to participate in the phase 1 clinical trial
on-going at the Medical College of Wiscsonsin (MCW). The FDA's recent Fast
Track Designation for GaM serves as the motivation behind this launch.

Under an EAP, also referred to as "compassionate use", the FDA works with
companies to allow access to investigational products outside of a clinical
trial. Patients who have limited or no viable treatment alternatives can gain
access to promising treatments, ahead of regulatory approval, in attempt to
fulfill an unmet clinical need.

To date, oral GaM has exhibited an excellent safety profile and promising
anti-tumor efficacy. Thus far, none of the patients that have participated in
the phase 1 trial have reported dose limiting toxicities. On the contrary,
patients have shared experiences of enhanced quality of life, allowing many
patients to engage in normal, pre-diagnosis, activities. Moreover, the agent
can be taken from the comfort of their home.

"Along with providing immediate access to GaM for the potential benefit of
some patients, the EAP will accelerate data obtained from a broader,
real-world, patient population. This data would advance the development
process on many levels including maximizing the full benefit of the Fast Track
Designation. Pending FDA approval, we expect the EAP to start in Q2," said
Trevor Brown, CEO of IQAI.

U.S. patients, patient-advocates, or physicians who are interested in learning
more can email eap@imagingbiometrics.com (mailto:eap@imagingbiometrics.com) .
Also, Imaging Biometrics' Policy on Expanded Access Programs, and general
information about the trial, can be found at
www.imagingbiometrics.com/clinical-trials/
(http://www.imagingbiometrics.com/clinical-trials/) .

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.

--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

 

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