Benitec Biopharma receives Russian regulatory approval for oncology study

Biopharmaceutical company Benitec Biopharma (ASX: BLT) is well on its way to generating clinical trial results for its potentially ground-breaking treatment of head and neck squamous cell carcinoma, a form of cancer that affects the outer layer of skin and in the mucous membranes in the human body.

After tabling the study in Australia, Benitec has decided to expand the study to Russia where its progress can be accelerated, and more data can be obtained to be able to progress the treatment towards final commercialisation.

Benitec received regulatory approval from Russia’s Ministry of Health (MoH) thereby allowing the conduct of a phase 2 HNSCC study in Russia. The MoH approval follows on from its separate approval from the Therapeutic Goods Administration (TGA) in Australia earlier this year.

Benitec is currently developing innovative therapeutics based on a combination of gene therapy and its patented gene-silencing technology named ddRNAi or “expressed RNAi”.

According to a regulatory filing with the TGA, the purpose of this study is to “evaluate the safety, tolerability and efficacy of intratumoral injections with an Epidermal Growth Factor Receptor (EGFR) AntiSense DNA (BB-401) in patients with metastatic/recurrent HNSCC.”

The study plans to recruit 30 participants at a maximum of 8 sites across Australia and Russia. As it stands, the study is expected to be fully completed by October 2019 and Benitec has announced that one of the first locations to conduct the trial in Australia will be the Chris O’Brien Lifehouse in Camperdown, New South Wales.

According to Benitec, “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.”

“We continue to make good progress in starting up the study in both Australia and Russia. We are now able to start treating head and neck cancer patients with this promising product and we look forward to the Russian clinical centres joining the study,” said Greg West, CEO of Benitec Biopharma.

As a company, Sydney-based Benitec also operates laboratory facilities in Hayward, California with collaborators and licensees globally.

The company is developing a range of potential solutions and ddRNAi-based therapeutics for chronic and life-threatening human conditions including OPMD, head & neck squamous cell carcinoma, retinal based diseases such as wet age-related macular degeneration, and hepatitis B.