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Tiziana Life Sciences Ltd (“Tiziana” or “the Company”) - Interim Results for the Six Months Ended 30 June 2022
Advancing pipeline of next generation therapeutics and diagnostics for oncology and immune diseases of high unmet need LONDON, Dec. 27, 2022 (GLOBE NEWSWIRE)
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"Advancing pipeline of next generation therapeutics and diagnostics for oncology and immune diseases of high unmet need\nLONDON, Dec. 27, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd (“Tiziana”, NASDAQ: TLSA), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases today announces its interim results for the six months ended 30 June 2022. Highlights during the period: CLINICAL and NON-CLINICAL PROGRAMMES ForalumabTZLS-401 Announced FDA approval for enrollment of a second, Secondary Progressive Multiple Sclerosis (SPMS) patient in under the Individual Patient Expanded Access (EA) Program following favorable clinical results after 6 months of treatment of the first patient in the EA program.Announced initiation of phase 1b clinical trial in Crohn’s disease patients to evaluate oral capsules of foralumab, a fully human anti-cd3 monoclonal antibody. The revised protocol allows for the study of a broader patient population and a shorter dosing period. These protocol amendments or revisions are intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022. This study is the first multiple-dose study with orally administered enteric-coated capsules of foralumab in patients with CD. This study will initiate soon with patient enrollment in the second quarter of 2022. Enteric-coated capsules, containing doses up to 5 mg of foralumab, will be administered once-daily for five consecutive days to patients with mild-to-moderately active CD. While the primary objective is safety and tolerability, additional endpoints are to assess clinical and immune signal responses, including calprotectin measurements in stool. Blood samples will be collected to evaluate pharmacokinetics, including the rate and extent of systemic absorption. The presence of anti-drug antibodies (ADAs) will also be determined.Announced that FDA granted permission to enroll up to 8 additional (SPMS) patients in the expanded access program with intranasal foralumab. The safety, tolerability, and clinical responses from the first two SPMS patients were submitted to the FDA to seek permission to treat up to an additional eight SPMS patients with the goal of obtaining more clinical data to assess robustness of the clinical responses. As part of the original treatment plan, the fora...