SAN DIEGO, Jan. 8, 2021 /PRNewswire/ -- Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative therapies, today announced dosing of the first patient in its biomarker guided Phase 3 clinical study evaluating the DB102 (enzastaurin) in combination with temozolomide and radiation as first line therapy to treat newly-diagnosed glioblastoma multiforme (GBM). This randomized, double-blind, placebo-controlled global study is to enroll more than 300 patients and the primary outcome measure is overall survival in patients with Denovo Genomic Marker 1 (DGM1). This GBM study has received Phase 3 permission from regulatory agencies from US, Canada, and China, and also gained FDA's Fast Track designation last year.
Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced FDA's approval to initiate Denovo's Phase 2b clinical study of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination with radiation and temozolomide
Denovo Biopharma LLC, a pioneer in using precision medicine to develop innovative therapies, today announced dosing of the first patient in its pivotal Phase 3 ENGINE trial. The ENGINE trial is a global, randomized, double-blind, registrational study evaluating the efficacy of DB102 in combination with R-CHOP versus R-CHOP alone in DLBCL patients with or without the biomarker DGM1.