HREC Approval of the Initiation of Phase 1 Study of GXV-001 in Australia

GEXVal Inc. has invited experienced doctors and specialists from Japan, Australia, Switzerland, Germany, the UK, and the US to build a global project team for the clinical development of GXV-001. GXV-001 is a candidate compound for multiple neurological rare diseases. Development activities have been coordinated to initiate the first-in-human study in Australia through our wholly owned subsidiary, GEXVal AU Pty Ltd. We submitted a Clinical Trial Notification to the HREC (Human Research Ethics Committee) in May 2022, the Ethics Committee for Clinical Studies in Australia. We are happy to announce that we received the approval dated June 10, 2022. Despite the COVID-19 pandemic, we will start subject recruitment once the clinical site becomes ready for the study. We sincerely appreciate your generous support and understanding.

Although this is just the first step, we firmly believe this will be a big step forward for patients and their families desperate for effective medicine.

What is HREC?
The Human Research Ethics Committee (HREC) in Australia is a regulatory body that reviews whether a proposed clinical study meets the ethical standards and the applicable guidelines.