Tiziana Life Sciences Ltd (NASDAQ:TLSA) has announced completion of the in-life portion of a 13-week, Good Laboratory Practice (GLP) foralumab intranasal pre-clinical study in transgenic HuGEMM CD3 mouse models.
The clinical-stage biopharmaceutical company said the study showed that intranasal foralumab administered to the transgenic mice at doses up to 50 microgram (µg) per rodent was clinically well tolerated.
“Completion of this preclinical trial is a critical milestone for Tiziana,” Tiziana Life Sciences interim CEO Gabriele Cerrone said in a statement.
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“The 13-week HuGEMM CD3 transgenic mouse 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 (ALS) and other planned intranasal foralumab CNS studies, and we can now move forward in a number of different indications,” Cerrone added.
Tiziana noted that 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.
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough immunomodulation therapies via novel routes of drug delivery.
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