IQ-AI Limited IB Announces Expanded Access Program for GaM
02 May 2024 - 9:47PM
RNS Regulatory News
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. Follow
IB on Twitter, @IQAI_IB.
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