CNS Pharmaceuticals Reports First Patient Enrollment in Pivotal Global Trial of Berubicin for Recurrent Glioblastoma Multiforme in Spain
Shots:
- The first patient has been enrolled in the pivotal global trial evaluating Berubicin vs Lomustine in patients with recurrent glioblastoma multiforme after the failure of standard 1L therapy. Of the 59 sites chosen across the US, Italy, France, Spain, and Switzerland, the company has already opened 37 clinical trial sites
- The 1EPs of the study is OS. After ~30-50% of all planned patients have reached the 1EPs expected in mid-2023, a pre-planned, non-binding futility analysis will be carried out & an additional assessment of safety & 2EPs will be included in this review
- Berubicin received the FTD from the US FDA & also received ODD from the US FDA which may provide 7yrs. of marketing exclusivity upon NDA approval
Ref: PRNewswire | Image: CNS Pharmaceuticals
Related News:- CNS Pharmaceuticals Initiates P-Ib/II Trial of Berubicin for the Treatment of Central Nervous System Lymphoma
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