Virax has lodged a Clinical Trial Application (CTA) with the South African Medicines Control Council (MCC) for approval to conduct a Phase I/IIa trial of the VIR201 HIV vaccine
A group of some of South Africa's leading HIV/Aids clinicians, led by Des Martin, president of the Southern African HIV/Aids Clinicians Society, has assisted in the development of a VIR201 clinical trial protocol suitable for the prevailing South African environment.
Whilst the MCC review process is conducted, Virax will continue to work with contract research organisation, Quintiles, to prepare suitable clinical trial sites and laboratories to support the trial.
It is anticipated that the trial will be conducted in five well established HIV clinics across South Africa.
Significant funding pledges to support the conduct of the trial have been secured from seven international companies with significant business ties in South Africa, with BHP Billiton as the cornerstone contributor.
The company is continuing to complete the total funding of the project.
An independent charitable trust has been established to receive the funding, following approval from the MCC for the trial to proceed.
Also, Virax is continuing to prepare an application, for lodgement with the United States Food and Drug Administration, to conduct a Phase II trial of the VIR201 HIV vaccine.
Application to other regulatory bodies will follow.
The trial is to be conducted in Australia, the USA and possibly other countries.
