US-based Halozyme Therapeutics has begun a Phase III clinical trial (Halo-301) of its investigational drug, PEGPH20, in combination with Abraxane (nab-paclitaxel) and gemcitabine for previously untreated metastatic pancreatic cancer patients.
The trial will evaluate the combination therapy in patients with tumours that accumulate high levels of hyaluronan (HA), a glycosaminoglycan (chain of natural sugars) that may impede drugs targeting the tumour.
According to the company, PEGPH20 temporarily degrades HA and has been shown in animal models to increase the concentration of co-administered therapies in the targeted tumour.
The company reported that an investigational device exemption (IDE), submitted to the US Food and Drug Administration (FDA) by its partner Ventana Medical Systems, has been approved for selection of patients with HA-High tumours.
The approval allows Halozyme to use the Ventana HA CDx Assay to identify HA-High patients for the trial.
University of California investigator Dr Margaret Tempero said: "High levels of HA have been associated with a worse prognosis in certain cancers, notably pancreas cancer.
"We have assembled a team of expert investigators at nearly 200 global sites to further study this potential link with the hope of bringing new treatment options to an area of high unmet need."
The trial is expected to enrol about 420 HA-high patients, and seeks to improve progression-free and overall survival in those receiving PEGPH20, Abraxane and gemcitabine compared to those receiving a placebo.
The FDA reportedly granted orphan drug status to PEGPH20 to treat pancreatic cancer, and fast track status for PEGPH20, in combination with gemcitabine and nab-paclitaxel, to treat metastatic pancreatic cancer.