Biosplice Therapeutics has initiated a Phase 2 clinical trial of its CLK/DYRK kinase inhibitor, cirtuvivint, in patients with advanced soft-tissue sarcomas. The multicenter, open-label trial, sponsored by the Sarcoma European and Latin American Network (SELNET), will enroll approximately 30 patients across eight Spanish clinical sites and evaluate cirtuvivint as a second-line monotherapy in specific sarcoma subtypes. SELNET’s decision to sponsor the trial stems from promising preclinical data demonstrating cirtuvivint’s efficacy in various treatment-resistant soft-tissue sarcoma models.
This trial is particularly important because it addresses the significant unmet need for effective second-line therapies for advanced soft-tissue sarcomas. Current treatment options are limited for patients whose disease progresses after initial standard of care, leaving them with few viable alternatives. The focus on specific sarcoma subtypes suggests a targeted approach based on preclinical findings, potentially leading to more effective personalized treatments. Furthermore, the collaboration between Biosplice and SELNET leverages the expertise of a specialized research network, facilitating efficient clinical investigation and potentially accelerating access to innovative therapies.
The Phase 2 trial will primarily assess the safety and efficacy of cirtuvivint in this patient population. Previous research has demonstrated the drug’s ability to modulate alternative pre-mRNA splicing, impacting genes crucial for tumor development and drug resistance. Data from earlier clinical trials exploring cirtuvivint in other advanced solid tumors and hematological malignancies will likely inform the current study and provide valuable context for interpreting the results.
Positive outcomes from this Phase 2 trial could significantly alter the treatment landscape for advanced soft-tissue sarcomas. Success could lead to the development of a new therapeutic option for patients who have exhausted existing treatments, improving their prognosis and quality of life. Furthermore, it could validate cirtuvivint’s mechanism of action in this specific cancer type, opening avenues for future research into its application in other sarcoma subtypes or related malignancies. This trial marks a crucial step towards personalized medicine in sarcoma treatment, potentially leading to more effective and targeted therapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
