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. Follow
IB on Twitter, @IQAI_IB.