Biosplice Announces First Patient Dosed in Phase 2 Trial of Cirtuvivint for Advanced Soft-Tissue Sarcomas
Friday, May 02, 2025
Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering advancements in small molecule inhibition of CDC-like kinases (CLK) and Dual-specificity tyrosine phosphorylation-regulated (DYRK) kinases, today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating cirtuvivint in patients with advanced soft-tissue sarcomas. The multicenter, open-label trial, led by Principal Investigator Dr. Javier Martin Broto, is sponsored by SELNET (Sarcoma European and Latin American Network) and is being conducted at eight clinical sites across Spain.
This Investigator Initiated Trial follows a preclinical collaboration and focuses on specific sarcoma subtypes, aiming to assess the safety and efficacy of cirtuvivint as a monotherapy. SELNET elected to sponsor the trial following a comprehensive review of preclinical data, which demonstrated compelling activity of cirtuvivint across multiple soft-tissue sarcoma cell lines and xenograft models that were refractory to other treatments.
The “Multicenter, Open-Label Phase 2 Trial of Cirtuvivint as a Second-Line Therapy in Selected Advanced Soft-Tissue Sarcomas" will evaluate cirtuvivint monotherapy in approximately 30 patients whose disease has progressed following initial standard of care. The trial focuses on specific sarcoma subtypes and aims to assess the safety and efficacy of cirtuvivint in this difficult-to-treat patient population.
“This trial represents a critical step forward for patients with advanced soft-tissue sarcomas, who currently face limited therapeutic options after first-line treatment,” said Dr. Yusuf Yazici, Chief Medical Officer of Biosplice. “We are grateful to SELNET and the participating investigators for their partnership in evaluating cirtuvivint in this patient population. Cirtuvivint has shown compelling activity in preclinical sarcoma models, and this study is a key milestone in our efforts to bring new therapeutic options to patients with high unmet need.”
Soft-tissue sarcomas (STS) are a heterogeneous group of rare cancers originating in connective tissues, and treatment-resistant forms of the disease remain a significant challenge. Biosplice is exploring cirtuvivint’s utility across multiple tumor types based on its unique mechanism of action and encouraging safety and pharmacokinetic profile observed in earlier studies.
Source: globenewswire.com
