First European Patient Dosed in Berubicin Trial for GBM

Glioblastoma multiforme (GBM) is notoriously difficult-to-treat. This cancer is both aggressive and invasive, spreading “tentacles” and becoming hard to remove even with surgery. As a result, finding more effective therapeutic options is an urgent and necessary endeavor. Currently, researchers are evaluating Berubicin, an anthracycline, as a potential treatment option for recurrent GBM. According to a news release from biopharmaceutical company CNS Pharmaceuticals, Inc., the first European patient has been both enrolled and dosed in this global trial

About Berubicin

CNS Pharmaceuticals explains that Berubicin is:

an innovative first in its class anthracycline to appear to cross over the blood brain barrier and kill tumor cells as a potential treatment option for glioblastoma. Berubicin appears to have a toxicity profile consistent with that of other anthracyclines and demonstrates exceptional activity as monotherapy for recurrent GBM.

Berubicin has been granted both Orphan Drug and Fast Track designations from the FDA. 

The Research Study

Altogether, sixty-eight research sites were chosen globally to hold this study. So far, 29 clinical trial sites have opened. The patient who was recently enrolled and dosed was located at the France site. During the study, researchers will evaluate the safety, efficacy, and tolerability of Berubicin for recurrent GBM in patients whose first-line therapy was unsuccessful. Researchers will also compare the efficacy of Berubicin to Lomustine. Ultimately, the team hopes to determine whether Berubicin improves overall survival rates as compared to the current standard-of-care. 

What is Glioblastoma Multiforme (GBM)? 

Glioblastoma is a rare and aggressive form of brain cancer. This cancer is considered to be a type of astrocytoma as it forms from star-shaped astrocyte cells. As described above, GBM can be extremely hard to treat. They are also fast-growing, especially as they’re able to make their own blood supply. Previous radiation therapy, pre-existing genetic disorders, and being male are all risk factors. The latter is because males are more susceptible than females to developing this cancer. Symptoms can (but do not always) include nausea and vomiting, double or blurred vision, difficulty thinking or speaking, severe or persistent headaches, seizures, and changes in mood, behavior, and personality.