Imaging Biometrics Launching an Expanded Access Program for Oral GaM
Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI Ltd (LSE: IQAI, OTCBB: IQAIF), is launching an intermediate population cohort expanded access program (EAP) for oral gallium maltolate (GaM), subject to FDA approval. The EAP will be for brain tumor patients located throughout the United States who are unable to participate in the phase 1 clinical trial on-going at the Medical College of Wiscsonsin (MCW). The FDA’s recent Fast Track Designation for GaM serves as the motivation behind this launch.
Under an EAP, also referred to as “compassionate use”, the FDA works with companies to allow access to investigational products outside of a clinical trial. Patients who have limited or no viable treatment alternatives can gain access to promising treatments, ahead of regulatory approval, in attempt to fulfill an unmet clinical need.
To date, oral GaM has exhibited an excellent safety profile and promising anti-tumor efficacy. Thus far, none of the patients that have participated in the phase 1 trial have reported dose limiting toxicities. On the contrary, patients have shared experiences of enhanced quality of life, allowing many patients to engage in normal, pre-diagnosis, activities. Moreover, the agent can be taken from the comfort of their home.
“Along with providing immediate access to GaM for the potential benefit of some patients, the EAP will accelerate data obtained from a broader, real-world, patient population. This data would advance the development process on many levels including maximizing the full benefit of the Fast Track Designation. Pending FDA approval, we expect the EAP to start in Q2,” said Trevor Brown, CEO of IQAI.
U.S. patients, patient-advocates, or physicians who are interested in learning more can email email@example.com. Also, Imaging Biometrics’ Policy on Expanded Access Programs, and general information about the trial, can be found at www.imagingbiometrics.com/clinical-trials/.
About Imaging Biometrics® LLC: IB is a wholly owned subsidiary of IQ-AI Limited, (LON: IQAI), and focuses 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. Follow IB on Twitter, @IQAI_IB.
The Directors of the Company accept responsibility for the contents of this announcement.
For further information, please contact:
Trevor Brown/Vinod Kaushal/Brett Skelly/Michael Schmainda
Tel: 020 7469 0930
Peterhouse Capital Limited (Financial Adviser and Broker)
Lucy Williams/Heena Karani
Tel: 020 7220 9797