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Denovo Begins Phase III Glioblastoma Trial of Enzastaurin

NEW YORK – Denovo Biopharma announced on Friday it has dosed the first patient in a Phase III trial evaluating enzastaurin, an inhibitor of the PKC beta, PI3K, and AKT pathways, with temozolomide and radiation as a first-line treatment for glioblastoma.

The trial will enroll up to 300 patients with newly diagnosed glioblastoma. They will receive either enzastaurin plus chemo and radiation or a placebo plus chemo and radiation. The primary endpoint for the trial is overall survival in patients with a biomarker, dubbed de novo genomic marker 1 (DGM1). The researchers will also evaluate treatment outcomes based on patients' MGMT promoter methylation status.

San Diego-based Denovo acquired worldwide rights to develop and commercialize enzastaurin, also called DB102, from Eli Lilly in 2014. Denovo decided to repurpose the drug after it failed initial Phase III studies run by Lilly. The company analyzed samples from patients who responded well to enzastaurin in those studies and identified the DGM1 biomarker as a predictor of treatment response.

In November Denovo began a Phase III trial of enzastaurin as a treatment for patients with high-risk, diffuse large B-cell lymphoma with the DGM1 biomarker.

"In both trials, we use DGM1 to identify the patients who will receive the most benefits from DB102 therapy in combination regimens," Zane Yang, Denovo chief medical officer, said in a statement. He added that the company is hoping its approach will result in a new treatment option in GBM that improves upon temozolomide chemotherapy.

Enzastaurin has received orphan drug designation in DLBCL and glioblastoma multiforme and fast track designation from the US Food and Drug Administration.