CNS Pharmaceuticals, Inc.(NASDAQ: CNSP) shares a shade below breakeven early Wednesday, after the company announced the activation of its first clinical trial sites in Europe for the ongoing potentially pivotal global trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer. These first European clinical trial sites in France and Spain are now open and actively enrolling patients.
CEO John Cilmaco declared, “Our primary focus continues to be on advancing the clinical development of Berubicin as a potential treatment option for this devastating disease.
“Over the course of this year, we have worked diligently to expand patient eligibility for our potentially pivotal trial and bolster our international presence now realized with the activation of the first two European clinical trial sites. This is a true testament to our team's commitment to and the execution of this important clinical program.”
Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM.
The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival, which is a rigorous endpoint that the Food and Drug Administration has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.
CNSP shares docked penny, or 4.8%, to 18.1 cents.
