CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) noticed its shares on the way up early Tuesday, on receiving a nod from European authorities.
CNS, a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced it has received approval from Swissmedic, the Swiss Agency for Therapeutic Products, for the Company's potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme (GBM).
With approvals now received from both swissethics, the umbrella organization of the cantonal Ethics Committees (EC) in Switzerland, and Swissmedic, the Company can proceed with site initiation and patient enrollment in Switzerland.
Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM.
The potentially pivotal global trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. Approximately 243 patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine for the evaluation of Overall Survival, the primary endpoint of the study.
Said CEO John Climaco, "We are sincerely grateful to the Swiss Competent Authority and Ethics Committee and their positive feedback on what we continue to believe is an incredibly important clinical program. We are laser focused on advancing Berubicin to unlock its greatest potential as a possible critical treatment option for this devastating disease. As long as the unmet medical need in GBM remains, we will continue our fight to bring hope to patients and families."
CNSP shares gained half a cent, or 1.6%, to 33.6 cents
