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Clinical Trials

Cornerstone initiates Phase II trial of CPI-613 to treat metastatic pancreatic cancer patients

PBR Staff Writer Published 01 November 2013

Cornerstone Pharmaceuticals has initiated a pilot Phase II clinical trial of its altered energy metabolism directed (AEMD) drug candidate CPI-613 for the treatment to treat patients with locally advanced or metastatic pancreatic cancer.

The company said CPI-613 is designed to disrupt the altered energy-production pathways in cancer cells.

Generally, pancreatic cancer begins in the tissues of the pancreas, an organ in the abdomen that helps in digestion and regulates the metabolism of sugars.

The trial is sponsored by the Comprehensive Cancer Center of Wake Forest Baptist Medical Center.

Patients with locally advanced or metastatic pancreatic cancer documented as having progression on a scan and that cannot be removed by surgery and have failed current available therapies, will be enrolled in the interventional trial.

The primary endpoint of the trial is to assess the overall survival, while the secondary endpoints include evaluating the overall response rate, progression free survival, and safety.

The US Food and Drug Administration (FDA) had granted orphan drug designation to CPI-613 in 2006, for the treatment of pancreatic cancer.

The company said during pre-clinical studies, its lead AEMD candidate 'CPI-613' has showed its ability to significantly disrupt the metabolic and regulatory process required for cell growth in solid tumour lines by exploiting a highly conserved bioenergetic feature of cancer cell metabolism.

Currently, CPI-613 is being assessed in Phase I, I/II and II human clinical trials in solid tumours and hematological malignancies.