Orphan Drug Designation Status

RNS Number : 3886R

IQ-AI Limited

28 February 2023

 

IQ-AI Announces Orphan Drug Designation Status

FDA grants orphan status to Gallium Maltolate for treating GBM

IQ-AI Limited, (LSE: IQAI) (OTCQB: IQAIF), is pleased to announce that the United States Food and Drug Administration (FDA) has granted orphan drug designation (ODD) status for gallium maltolate (GaM) for the treatment of glioblastoma multiforme (GBM) brain cancer. GaM is the oral agent under study in IQAI's sponsored Phase I clinical trial being conducted at the Medical College of Wisconsin (MCW) in Milwaukee, Wisconsin.

ODD status is given to drugs that show promise in treating rare diseases or conditions that affect fewer than 200,000 people in the United States. These diseases are typically serious or life threatening. In 1983, the US government passed the Orphan Drug Act to provide companies with certain benefits for developing orphan drugs with the goal of accelerating drug development for these patients.

The ODD status is independent of the overall approval process by the FDA. However, as the clinical trial continues, IQAI intends to take full advantage of the benefits orphan designation offers including assistance in the drug development process, tax credits, grant opportunities, and seven years of market exclusivity post-approval.

Enrolment is ongoing in the Phase I clinical trial to evaluate the safety and tolerability of GaM and to identify the recommended phase 2 dose (RP2D) necessary for a Phase II clinical trial. A Phase II clinical trial, the next major developmental step, will be undertaken to officially assess if GaM works in GBM.

"This designation is a critical milestone in the development of GaM. It brings the possibility of making an oral agent available as a treatment option for glioblastoma multiforme brain cancer, closer to reality," said Trevor Brown, CEO of IQ-AI Limited.

The Directors of the Company accept responsibility for the contents of this announcement.

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For further information, please contact:

IQ-AI Limited

Trevor Brown/Brett Skelly/Vinod Kaushal

Tel: [phone]

Peterhouse Capital Limited (Financial Adviser and Broker)

Lucy Williams/Heena Karani

Tel: [phone]

About IQ-AI Limited

IQ-AI Limited, (LON: IQAI) (OTCQB: IQAIF), the parent company of Wisconsin-based Imaging Biometrics, LLC (IB), is focused 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

 

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