Research & Development
Denovo Biopharma doses first patient in biomarker guided Phase three clinical study of DB102 in combination with temozolomide and radiation
11 January 2021 -

United States-based Denovo Biopharma LLC has dosed the first patient in its biomarker guided Phase three clinical study assessing DB102 (enzastaurin) in combination with temozolomide and radiation as a first line therapy intended to treat glioblastoma multiforme (GBM), it was reported on Friday.

The study is a randomised, double-blind, placebo-controlled global study that will enrol over 300 patients. The study's primary outcome measure is the overall survival in patients with Denovo Genomic Marker 1. The regulatory agencies from US, Canada, and China have approved the phase three study that also received Fast Track designation from FDA last year.

Zane Yang, MD, Denovo's CMO, said, 'This GBM study is the second global Phase 3 trial of DB102 for patients with cancer following our first global Phase 3 trial of DB102 for patients with diffuse large B-cell lymphoma (DLBCL). In both trials, we use DGM1 to identify the patients who will receive the most benefits from DB102 therapy in combination regimens. GBM remains to be one of the deadliest cancers and the first line drug treatment still relies on temozolomide as the backbone -- many promising anticancer drugs, including anti-PD-1 drugs, have failed to improve upon temozolomide's efficacy. I am hopeful that our innovative approach can bring new hope to patients with this difficult-to-treat condition that continues to have a significant unmet need.'

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