Business
Orphan Drug Designation Status
Orphan Drug Designation Status.
About this update from Imaging Biometrics Limited
[{"type":"text","content":"\n \n \n \n \n \n \n \n \n \n \n IQ-AI Announces Orphan Drug Designation Status\n \n \n \n \n FDA grants orphan status to Gallium Maltolate for treating GBM\n \n \n \n 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.\n \n \n \n \n \n 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.\n \n \n \n \n \n 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.\n \n \n \n \n \n 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.\n \n \n \n \n \n \"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.\n \n \n \n \n \n The Directors of the Company accept responsibility for the contents of this announcement.\n \n \n \n \n \n -ENDS-\n \n \n \n \n \n For further information, please contact:\n \n \n \n \n \n IQ-AI Limited\n \n \n Trevor Brown/Brett Skelly/Vinod Kaushal\n \n \n Tel: 020 7469 0930\n \n \n \n \n \n Peterhouse Capital Limited (Financial Ad...