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Brain tumors are a malignancy for which treatment is generally unsuccessful, with 22,000 diagnoses and 13,000 annual deaths annually in the U.S. alone according to the American Cancer Society. Malignant gliomas, most commonly glioblastoma multiforme (GBM), account for the majority of deaths. Despite aggressive and costly new therapies, median survival is still less than 15 months.  Even after ‘gross total resection,’ tumors recur due to infiltrative tumor cells outside the main tumor mass resulting in a median survival for recurrent GBM of less than 6 months.  Malignant gliomas represent a dire, unmet medical need.


Results from our recently completed Phase 2 trial in this disease were extremely promising, with a statistically significant increase of 3.6 months vs. control in overall survival (p=0.04).  A dramatic increase in overall survival vs. control was demonstrated for the pre-planned subset of glioblastoma patients that achieved gross total resection, with 33.3% of patients alive at three years vs. 4.5% of patients in the control group (p=0.006).  The data from this trial were presented in an oral presentation at ASCO 2015 (link) and published February 2, 2016 in Neuro-Oncology (link). Based on these promising results, we are currently planning additional clinical studies.


Principal Investigator


E. Antonio Chiocca, M.D., Ph.D.,

Neurosurgeon-in-Chief and Chairman, Department of Neurosurgery

Brigham and Women's / Faulkner Hospital

Surgical Director, Center for Neuro-oncology

Dana-Farber Cancer Institute.




 

For more information on  BrTK02  study , Click

Clinicaltrials.gov

Malignant Glioma