CNS Pharmaceuticals, Inc. is a preclinical stage pharmaceutical company, which engages in the development of anticancer drug candidates for the treatment of primary and metastatic brain and central nervous system tumors. Its product pipeline includes berubicin, and CNS-12. The company was founded by Waldemar Priebe in July 2017 and is headquartered in Houston, TX.
相关临床试验
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2 进行中
药物批准
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成立时间
2017
进行中（未招募）
2
100.0%
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- CNS Pharmaceuticals' Chief Medical Officer Sandra Silberman presented TPI 287, a brain-penetrating abeotaxane, at the 2025 Brain Tumor Biotech Summit on June 5, 2025. - TPI 287 demonstrated promising efficacy in a Phase 1 trial for glioblastoma, achieving 3 complete responses and 9 partial responses out of 23 evaluable patients when combined with bevacizumab. - The drug has received FDA Orphan Drug Designation for treating gliomas, pediatric neuroblastoma, and progressive supranuclear palsy, distinguishing it from other taxanes that cannot cross the blood-brain barrier. - TPI 287 has been tested in over 350 patients across multiple clinical trials, showing an excellent safety profile and high tolerability for various brain and central nervous system cancers.
• CNS Pharmaceuticals has successfully acquired Orphan Drug Designation from Cortice Biosciences for TPI 287, a novel abeotaxane with potential to cross the blood-brain barrier for treating brain tumors. • In early clinical trials, TPI 287 combined with bevacizumab showed promising efficacy against glioblastoma multiforme (GBM), with 3 complete responses and 9 partial responses among 23 evaluable patients. • The company plans to begin patient enrollment for a Phase 2 study by the end of 2025, with the Orphan Drug status potentially providing seven years of market exclusivity upon approval.
- CNS Pharmaceuticals released topline data from a Phase II/III clinical trial evaluating Berubicin versus Lomustine in 252 patients with recurrent Glioblastoma Multiforme. - The trial showed Berubicin produced clinically relevant outcomes comparable to Lomustine across multiple endpoints but failed to demonstrate statistically significant improvement in overall survival, the primary endpoint. - Despite the mixed results, the company is evaluating potential paths forward for the program in consultation with the FDA, given the limited treatment options for glioblastoma patients.
• CNS Pharmaceuticals' Berubicin failed to demonstrate statistically significant superiority in overall survival compared to Lomustine in recurrent glioblastoma patients, but showed comparable clinical outcomes across multiple endpoints. • Unlike other anthracyclines, Berubicin demonstrated no cardiotoxicity even in patients receiving treatment for over a year, and avoided pulmonary toxicity and thrombocytopenia associated with Lomustine. • As the first anthracycline proven to cross the blood-brain barrier effectively, Berubicin may represent a valuable alternative treatment option for patients with aggressive brain cancers despite missing its primary endpoint.
• CNS Pharmaceuticals presented updated results from its pivotal study comparing Berubicin to Lomustine in recurrent glioblastoma (GBM) patients, showing comparable demographics between treatment arms. • The Berubicin arm exhibited higher study completion rates (84.7%) compared to Lomustine (78.9%), alongside lower withdrawal rates (11.0% vs. 19.7%), suggesting better tolerability. • Safety profiles were similar, with Berubicin showing slightly higher rates of anemia and neutropenia, while Lomustine had more thrombocytopenia cases. • The company anticipates reporting primary analysis data in the first half of 2025, with overall survival as the primary endpoint.
