Berg, a US-based biopharmaceutical firm, has begun a Phase II clinical trial for its drug candidate BPM 31510 in combination with gemcitabine for the potential treatment of pancreatic cancer.
Pancreatic cancer develops when cells in the pancreas, a glandular organ behind the stomach, begin to multiply out of control and form a mass. These cancerous cells could invade other parts of the body.
The primary objective of the Phase II trial is to evaluate safety and efficacy in around 25 adults with metastatic pancreatic adenocarcinoma.
Berg noted that BPM 31510's mechanism reverses the metabolism of a cancer cell and reactivating cell death pathways in mitochondria to behave much like a normal cell.
During Phase II clinical trial, BPM 31510 is being administered as a 144 hour continuous intravenous (IV) infusion along with gemcitabine in advanced pancreatic cancer patients as second line therapy, at a starting dose of 110mg/kg.
Gemcitabine is said to be the current standard treatment option for patients with pancreatic ductal adenocarcinoma, which represents 80% of cases.
The trial's primary end point is overall response rate (ORR), comprising complete responses (CR) and partial responses (PR).
Secondary outcome measures involve overall survival (OS), time to progression (TTP), progression-free survival (PFS), as well as an evaluation of the drug combination's safety and change in CA 19-9 levels.
The Phase II open-label, non-randomised clinical trial is initially being conducted at Beth Israel Deaconess Medical Centre and US' Mayo Clinic, Medical College of Wisconsin and Vita Medical Associates.
Over the next 12 months, more sites will be added to the study, led by principal investigator Ramesh Ramanathan who is the director of GI medical oncology at Mayo Clinic in Arizona, US.
The Phase I results of the study suggest that BPM 31510 is well-tolerated in monotherapy, as well as in combination with a chemotherapy agent. Early anti-tumour activity was also seen during the trial.
With the help of Berg's Interrogative Biology Platform, the Phase II study expects to include a precision medicine approach by collecting blood and tissue samples from patents to create 'Molecular Maps' on patients with the disease, in order to assess patients who will be the most effective match for the treatment and have a higher likelihood of responding.