The company is developing innovative therapeutics based on a combination of gene therapy and a patented gene-silencing technology called ddRNAi.
The phase II open-label study has been designed to explore the safety, tolerability and efficacy of BB401 following injections into the lesions of patients with recurrent or metastatic head and neck cancer.
The study will enrol up to 30 patients at 5-8 sites across Australia and Russia.
Objective is to control the progression of cancer
BB-401 is a recombinant DNA (deoxyribonucleic acid) construct that produces an antisense RNA (ribonucleic acid) with specificity against Epidermal Growth Factor Receptor (EGFR).
More than 90% of lesions from patients show significantly increased EGFR levels associated with head and neck cancer.
The goal of this study is to inhibit the expression of EGFR in the treated lesions and thus control the progression of the disease and increase patient survival.
Significant market potential
In 2016, circa 64,000 new cases of head and neck cancer were estimated to have been diagnosed in the U.S., resulting in more than 13,000 deaths.
Total drugs sales for this type of cancer in the seven major markets (U.S., France, Germany, Italy, Spain, UK and Japan) is expected to increase from $386 million in 2014 to $1.53 billion in 2024.
Benitec’s new study represents an important milestone 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.