Pancreatic cancer is a disease with a high unmet medical need. In 2017, an estimated 53,070 adults in the United States will be diagnosed with pancreatic cancer. The majority of pancreatic cancer cases are diagnosed late, at which point the disease is already locally advanced or metastatic. The disease accounts for about 3 percent of all cancers in the US and is the fourth leading cause of cancer death in men and women according to the American Cancer Society.
BERG’s Pancreatic Cancer Drug Candidate (BPM 31510) Received FDA Orphan-Drug Designation in November 2017.
BPM 31510 is an intravenous formulation of ubidecarenone (coenzyme Q10) in clinical development for several cancers including the treatment of advanced pancreatic cancer.
Cancer cells alter metabolism to generate energy from non-mitochondrial pathways to support uncontrolled growth. This allows the cancer cells to escape molecular mechanisms controlling cell death. BPM31510 is a first in class molecule that specifically targets the dysregulated metabolism observed in cancer. BPM31510, by targeting metabolism in cancer cells, re-engages the mitochondria to generate energy, shifting metabolism to that observed in the normal cell. The effect of BPM31510 on metabolism results in the reactivation of pathways that detect cell damage, triggering apoptosis or programmed cell death.
After completion of a Phase 1 clinical trial establishing safety, BERG initiated a precision medicine driven Phase 2 clinical trial design for BPM31510, alone and in combination with gemcitabine to evaluate the efficacy in patients with advanced pancreatic cancer in the US and Europe. As part of this Phase 2 trial, BERG is driving towards identification and validation of molecular profiles representative of BPM31510 mediated outcomes, which could lead to a diagnostic panel for patient stratification.
This clinical trial is actively recruiting.
For more information about the trial, please click here.