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

Cornerstone’s 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 as well as regulates the metabolism of sugars.

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, which is sponsored by the Comprehensive Cancer Center of Wake Forest Baptist Medical Center.

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.

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

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Wake Forest Baptist assistant professor of internal medicine-hematology and oncology Angela Alistar is serving as the principal investigator for the trial.

Alistar said diagnosing pancreatic cancer is challenging due to the gradual development of symptoms, which are not always obvious during the early stages.

"In a majority of cases, the cancer is in an advanced stage when it is discovered and by this time the survival rate is very low."

"In a majority of cases, the cancer is in an advanced stage when it is discovered and by this time the survival rate is very low," Alistar said.

"With an overall 5-year relative survival rate of only 6%, even if diagnosed in an early stage pancreatic cancer is one of the more fatal forms of 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.

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

The lead drug candidate induces cancer-specific inhibition of pyruvate dehydrogenase (PDH) and alpha ketoglutarate dehydrogenase (KGDH), key mitochondrial enzymes involved in fueling cancer cell metabolism.

Image: Histopathogic image of pancreatic adenocarcinoma arising in the pancreas head region. Photo: courtesy of KGH.