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Threshold begins Phase II trial tarloxotinib to treat head and neck or skin cancers

Threshold Pharmaceuticals has started a Phase II trial of tarloxotinib bromide or 'tarloxotinib' (TH-4000), to treat patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) or skin (SCCS).

Tarloxotinib is the company’s hypoxia-activated, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor licensed from the University of Auckland, New Zealand.

The company noted that elevated expression of wild-type EGFR and its stimulatory ligands occurs in the majority of squamous cell carcinomas.

Peter MacCallum Cancer Centre Division of Cancer Medicine co-director and principal investigator of the phase II trial Danny Rischin said: "New and effective treatment options are urgently needed for patients with squamous cell carcinomas.

"Tarloxotinib represents a novel treatment approach that may allow effective inhibition of EGFR signaling in the tumor microenvironment with relative sparing of normal tissues."

The single-arm, open label Phase II trial will enroll about 68 patients with recurrent or metastatic SCCHN or SCCS and eligible patients will receive tarloxotinib (150mg/m2 by intravenous infusion) on Days 1, 8, 15 and 22 of a 28-day cycle.

Threshold chief medical officer Tillman Pearce said: "We are pleased that tarloxotinib is actively being investigated in two monotherapy Phase II proof-of-concept trials, the other being in patients with non-small cell lung cancer.

"These clinical settings, in which EGFR is already a validated therapeutic target, represent opportune development paths for tarloxotinib, which is designed to exploit the reported overlap between elevated EGFR signaling and tumor hypoxia.

"By selectively targeting the hypoxic tumor microenvironment, tarloxotinib has the potential to increase the therapeutic index and overcome limitations of current EGFR inhibitor therapy, which may lead to improved outcomes for patients with these EGFR-dependent cancers."