Biologically-active Tat has been shown to be well tolerated and safe in both pre-clinical and Phase I clinical trials. It has also been proven to be efficacious in pre-clinical studies. However, Tat oxydes very easily loosing its biological activity.
Biologically-active Tat is obtained though a complex manufacturing process that inhibits oxidation. The manufacturing process by which biologically active Tat is obtained has been developed in collaboration with scientists at the University of Urbino, led by Prof. Mauro Magnani. The process is complex due to the highly fragile nature of Tat when exposed to oxygen during production.
The production process has now been perfected and transferred for scale up and production under GMP conditions. This will be done at AVITECH, the GMP biopharmaceutical manufacturing facility of a spin-off company of the University of Urbino, Italy.
AVITECH has already manufactured biologically active Tat for the ongoing trials.