Tag: safety profile

11 of 12 participants (92%) enrolled in the 180mg cohort achieved a complete response

NEW YORK, June 13, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announces that dosing has commenced at the prestigious Weill Cornell Medicine Multiple Sclerosis Center in New York City, in its ongoing Phase 2 clinical trial evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). This fifth site complements existing sites at Yale University, Johns Hopkins University, Brigham and Women's Hospital, and the University of Massachusetts.

Data reported from the ongoing ATALANTA-1 Phase 1/2 study in a heavily pretreated relapsed refractory non-Hodgkin’s Lymphoma (R/R NHL) patient population demonstrate low rates of high-grade toxicities

- AGA2115 also received Orphan Drug Designation from European Medicines Agency

Cross-study findings indicate significant clinical benefit of frontline fixed-duration ibrutinib plus venetoclax with improved likelihood of undetectable minimal residual disease and progression-free survival versus acalabrutinib plus venetoclax¹

BRUSSELS and CAMBRIDGE, Mass., June 12, 2025 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today presented additional detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate. In the study, DZP demonstrated significant clinical improvements in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE), as measured by the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) at Week 48, the primary endpoint. Improvements were also seen across additional clinical measures, including fatigue and disease activity/remission. These results were presented at EULAR 2025, the European Alliance of Associations for Rheumatology’s annual meeting, in Barcelona, Spain. The safety and efficacy of DZP in SLE have not been established, and it is not approved for use in SLE by any regulatory authority worldwide. A second Phase 3 trial of dapirolizumab pegol is ongoing with the goal of confirming the results from PHOENYCS GO.

PESG issues a new briefing following PolyPid’s clinical success; Revolutionary 58% Reduction in Surgical Site Infections Positions PolyPid’s D-PLEX100 as Potential New Standard of Care in the Future

US EPA projects taking a regulatory decision by end of September 2025; Dutch authorities finalise first phase of regulatory dossier for EVOCA in Europe