Unlock Premium Data: Up to 50% Off InvestingProCLAIM SALE

IQ-AI boosted with second FDA rare pediatric disease designation for GaM

Published 20/05/2024, 09:05
IQ-AI boosted with second FDA rare pediatric disease designation for GaM
IQAI
-

Proactive Investors - IQ-AI Ltd (LON:IQAI) told investors that its subsidiary, Imaging Biometrics, has received a second US FDA Rare Pediatric Disease Designation (RPDD) for its lead drug candidate, oral gallium maltolate (GaM).

The designation is for the treatment of pediatric-type diffuse high-grade glioma (HGG), a cancer with poor prognosis due to the early dissemination of cancer cells and challenges in surgical resection, it noted.

Such designations provide significant strategic and financial benefits, including eligibility for Priority Review Vouchers (PRVs) which can expedite FDA review processes, or can be sold to other companies.

"This second Rare Pediatric Disease Designation for IB-003 reflects our commitment to address the needs of children affected by these conditions," Q-AI chief executive Trevor Brown said in a statement.

"Building upon these designations, we are exploring ways to accelerate and expand the application of IB-003."

HGG comprises four distinct subtypes as classified by the 2021 World Health Organization (WHO) CNS5. These subtypes are diffuse midline glioma, diffuse hemispheric glioma H3 G34-mutant, diffuse pediatric high-grade glioma H3 wildtype and IDH wildtype, and infant-type hemispheric glioma.

The FDA defines rare pediatric diseases as serious or life-threatening conditions affecting fewer than 200,000 individuals under 18 years of age.

GaM's RPDD follows an earlier designation for the treatment of atypical teratoid rhabdoid tumor (ATRT), leveraging pre-clinical data that showed growth inhibition and extended survival in treated groups.

Read more on Proactive Investors UK

Disclaimer

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.