Tiziana Life Sciences completes prerequisite pre-clinical safety study

Tiziana Life Sciences announces completion of the in-life portion of a 13-week, Good Laboratory Practice foralumab intranasal pre-clinical study in transgenic HuGEMM CD3 mouse models. The study showed that intranasal foralumab, administered to the transgenic mice at doses up to 50 microgram/rodent, was clinically well tolerated. Specifically, in the study no related changes in clinical signs, body weight, hematology, coagulation, clinical chemistry, functional observational battery, organ weight or macroscopic changes and no foralumab-related deaths were reported. Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana, remarked, "Completion of this preclinical trial is a critical milestone for Tiziana. The 13-week HuGEMM CD3 transgenic mouse 13-week study is a common pre-requisite requirement needed to support an FDA Phase 2 meeting request to study investigational candidates in MS, Alzheimer’s Disease, Amyotrophic Lateral Sclerosis and other planned intranasal foralumab CNS studies, and we can now move forward in a number of different indications."