Berubicin: Anthracyclines inhibit the topoisomerase II enzyme to disrupt DNA and RNA synthesis by intercalating between base pairs of the DNA/RNA strand, thus preventing the replication of rapidly growing cancer cells.
About Berubicin
Berubicin is a novel, synthetic, second-generation anthracycline-based topoisomerase II inhibitor engineered to circumvent the the BBB and overcome MDR. Berubicin has been administered to humans in 4 clinical trials to date.
Anthracyclines inhibit the topoisomerase II enzyme to disrupt DNA and RNA synthesis by intercalating between base pairs of the DNA/RNA strand.
Berubicin was Evaluated in a Late-Stage Global Clinical Trial for the Treatment of Glioblastoma Multiforme (GBM)
Summer of Primary Analysis
- Showed clinically relevant outcomes comparable to Lomustine across multiple endpoints1
- Safety profile continues to be favorable, including the absence of anthracycline related cardiotoxicity
- Analysis of outcomes are ongoing, including advanced imaging review, PK, and clinical endpoints
Ongoing Analysis of Outcomes
- Did not demonstrate a statistically significant difference in overall survival, the primary endpoint
Program Highlights
- Evaluated in multiple Phase 1 and Phase 2 studies
- Fast Track Designation
- Orphan Drug Designation with 7 years market exclusivity in the U.S.
- On-going GBM trial.
References
- 1. Zielinski, R., Cardenas-Zuniga, R., Poimenidou M., et al. Neuro-Oncol. 2021; 23 (6):1