IQ-AI Announces Orphan Drug Designation Status

Rhea-AI Summary

IQ-AI Limited (OTCQB:IQAIF) has received orphan drug designation (ODD) from the FDA for gallium maltolate (GaM) aimed at treating glioblastoma multiforme (GBM). This designation supports the ongoing Phase I clinical trial at the Medical College of Wisconsin, which assesses GaM's safety and tolerability. Orphan designation offers several advantages including tax credits, grant opportunities, and seven years of market exclusivity post-approval. CEO Trevor Brown highlighted that this milestone brings the potential for GaM as a treatment option for GBM closer to realization.

Positive

• FDA granted orphan drug designation for gallium maltolate, enhancing its development prospects.
• Potential to provide a new treatment option for a serious condition affecting fewer than 200,000 patients.
• The designation offers benefits such as tax credits and grants, and seven years of market exclusivity.

Negative

• None.

MILWAUKEE, WI / ACCESSWIRE / February 28, 2023 / IQ-AI Limited, (OTCQB:IQAIF)(LSE:IQAI), and its US-based subsidiary, Imaging Biometrics, LLC (Milwaukee, WI) 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.

Enrollment 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 GBM 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.

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

SOURCE: IQ AI Ltd.

View source version on accesswire.com:
https://www.accesswire.com/741268/IQ-AI-Announces-Orphan-Drug-Designation-Status

FAQ

What is the significance of the FDA granting orphan drug designation to IQ-AI for gallium maltolate?

The orphan drug designation provides IQ-AI with benefits that may accelerate the development and approval process for gallium maltolate as a treatment for glioblastoma multiforme.

What is gallium maltolate, and what is it being tested for?

Gallium maltolate is an oral agent being studied for its efficacy in treating glioblastoma multiforme in a Phase I clinical trial.

What advantages does orphan drug designation provide IQ-AI?

The designation offers tax credits, grant opportunities, and seven years of market exclusivity following FDA approval.

Where is the clinical trial for gallium maltolate being conducted?

The Phase I clinical trial for gallium maltolate is being conducted at the Medical College of Wisconsin in Milwaukee.

What phase follows the Phase I trial for gallium maltolate?

If the Phase I trial is successful, a Phase II clinical trial will be conducted to officially evaluate the drug's effectiveness in glioblastoma multiforme.