Australian biotechnology company Benitec Biopharma has commenced a Phase II trial to evaluate BB-401 for the treatment of patients with head and neck squamous cell carcinoma (HNSCC).
The open label trial has been designed to examine the safety, tolerability and efficacy of BB-401 following intratumoral injections into the lesions of patients with recurrent or metastatic HNSCC.
It expects to enrol up to 30 patients at five to eight sites across Australia and Russia.
The trial aims to inhibit the expression of epidermal growth factor receptor (EGFR) in the treated lesion and thereby control the progression of HNSCC and increase patient survival.
Benitec Biopharma CEO Greg West said: “This represents an important milestone for us in the progression of BB-401 as a treatment option for patients with advanced head and neck cancer who have failed all other treatment modalities.
“We are on track to start screening patients shortly.”
Head and neck cancers typically begin in the squamous cells that line the moist mucosal surfaces inside the head and neck, including inside the mouth and the throat.
In 2016, roughly 64,000 new cases of head and neck cancer were estimated to have been diagnosed in the US, leading to the death of more than 13,000 people.
Head and neck cancers are reported to be more than twice as common among men as they are among women.
BB-401, which is currently under development by Benitec Biopharma, is a recombinant deoxyribonucleic acid (DNA) construct that produces an antisense RNA with specificity against EGFR.
Benitec Biopharma noted that more than 90% of lesions from patients demonstrate significantly increased EGFR levels associated with HNSCC.