Tiziana Life Sciences initiates Phase 2a trial of intranasal foralumab

Tiziana Life Sciences announced that it held an Investigator’s Meeting with principal investigators at Brigham and Women’s Hospital to begin site initiation for its lead intranasal foralumab program entering Phase 2a clinical testing in non-active Secondary Progressive Multiple Sclerosis, na-SPMS, patients. In total, six to ten new clinical trial sites will be recruited. Matthew Davis, M.D., RPh, Chief Operating Officer and Chief Medical Officer of Tiziana Life Sciences, stated, “As planned for this quarter, we are on track and have begun site initiation visits so patient enrollment begins in this critical clinical trial. Advancing our lead anti-CD3 therapeutic, foralumab, in na-SPMS into Phase 2a will enable Tiziana to define novel endpoints, such as PET imaging, a similar target endpoint in our Expanded Access program. We are encouraged as five out of six patients in our open-label EAP have improved by qualitative analysis in their PET scans compared to baseline. Phase 2a na-SPMS study assesses the same outcome measure, but now, and for the first time for this novel therapeutic, in a double-blind, randomized placebo control, a multi-center trial is now underway.”