REG - IQ-AI Limited - Promising Preliminary Results of Phase 1 Study

IQ-AIAnnouncement

11/04/2025 15:45

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250411:nRSK7655Ea&default-theme=true

RNS Number : 7655E  IQ-AI Limited  11 April 2025

IQ-AI Ltd

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

Imaging Biometrics Announces Promising Preliminary Results of Phase 1 Study

 

Oral Gallium Maltolate Demonstrates Early Signals of Efficacy

 

IQ-AI is pleased to provide the following update on its wholly-owned
subsidiary, Imaging Biometrics LLC.

The study on patients with recurrent/refractory glioblastoma is nearing
completion, with three subjects left to be enrolled in the expansion phase.

The agent, oral GaM, is taken daily and has demonstrated excellent
tolerability, with no serious adverse events reported.

Among the 23 subjects with evaluable data, early signs of efficacy have been
observed, with an overall survival ("OS") of 32 months.

Elm Grove, WI, April xx, 2025 - Imaging Biometrics, LLC (IB) today announced
promising preliminary data from their ongoing Phase 1 clinical dose escalation
study of oral GaM in patients with recurrent/refractory glioblastoma. This
marks the first in-human study results of GaM for glioblastoma.

 

Overall survival for all glioblastoma patients is 8-9 months, but has been
shown to be prolonged with redo surgery to up to 20 months. Of the 23 subjects
evaluable in this Phase 1 study, 19 underwent redo surgeries.

 

Among evaluable glioblastoma patients in this Phase 1 trial, overall survival
is 14 months from GaM treatment intitiation and 32 months from the time of
initial diagnosis. This takes into account all the significant factors such as
age, methylation (MGMT) status, previous surgical resections, etc. This
represents a positive signal of response.

 

"While this data is preliminary and further work is required, we are very
encouraged by the promising early signals suggesting prolonged overall
survival and potential anti-tumor activity with GaM," said Trevor Brown, CEO
of  IQAI.

 

Data also indicate that trial patients experienced a progression-free-survival
("PFS") of 2 months without tumor worsening. This is comparable to the current
PFS of 1-2 months for recurrent glioblastoma patients undergoing standard
therapy. While these findings suggest that PFS is not changed compared to
current numbers, patients may have benefitted from disease stability as
evidenced by their prolonged overall survival.

 

It should also be noted that determination of PFS was based on standard
radiologic (RANO) response criteria, which often cannot reliably distinguish
tumour progression from effects due to treatment. Advanced quantitative
imaging, such as what is provided by IB's FTB maps, are also being evaluated
as a more accurate way to assess PFS and may lend further insight on the
response to treatments such as GaM.

 

For further information, please contact:

  IQ-AI Ltd

 Trevor Brown/Dr Musella/Brett Skelly/Michael Schmainda

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

 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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDEALLFFAXSEFA