Date: 2018-05-24
Type of
information: Clinical trial authorisation
phase: 2
Announcement: clinical trial authorization
Company: Benitec Biopharma (Australia)
Product: BB-401
Action
mechanism:
- antisense RNA. BB-401 is a DNA plasmid that produces an antisense RNA that targets the Epidermal Growth Factor Receptor (EGFR) mRNA and prevents its translation into its cognate protein by post transcriptional gene silencing.
Disease: head and neck squamous cell carcinoma (HNSCC)
Therapeutic
area: Cancer - Oncology
Country: Australia, Russian Federation
Trial
details:
- 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. (NCT03433027)
Latest
news:
- • On May 24, 2018, Benitec Biopharma provided an update on advancements of its Phase 2 clinical study in Australia with BB-401, as a treatment for patients with head and neck squamous cell carcinoma (HNSCC). Benitec has now received Regulatory Approval from the Ministry of Health (MoH) of the Russian Federation allowing the conduct of the Phase 2 HNSCC study in Russia. The MoH approval follows the recently announced Australian Regulatory Approval from the Therapeutics Goods Administration (TGA).
- The Phase 2 open label study has been designed to explore the safety, tolerability and efficacy of BB401 following intratumoral injections into the lesions of patients with recurrent or metastatic HNSCC. The study will enrol up to 30 patients at 5-8 sites across Australia and Russia.
Is
general: Yes
