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IQAI Iq-ai Limited

1.35
0.00 (0.00%)
Last Updated: 08:00:03
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Iq-ai Limited LSE:IQAI London Ordinary Share JE00BD4H0R42 ORD GBP0.01
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 1.35 1.30 1.40 1.35 1.285 1.35 500,006 08:00:03
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
Florists 536k -512k -0.0028 -4.82 2.47M

IQ-AI Limited Orphan Drug Designation Status (3886R)

28/02/2023 3:52pm

UK Regulatory


Iq-ai (LSE:IQAI)
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TIDMIQAI

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.

-ENDS-

For further information, please contact:

IQ-AI Limited

Trevor Brown/Brett Skelly/Vinod Kaushal

Tel: 020 7469 0930

Peterhouse Capital Limited (Financial Adviser and Broker)

Lucy Williams/Heena Karani

Tel: 020 7220 9797

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

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 or visit 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.

END

STRSEUFIAEDSELE

(END) Dow Jones Newswires

February 28, 2023 10:52 ET (15:52 GMT)

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