SYDNEY and HAYWARD,
Calif., Dec. 21, 2018
/PRNewswire/ -- Benitec Biopharma (ASX: BLT, NADSAQ: BNTC)
(the "Company"), a clinical-stage biotechnology company developing
novel genetic medicines via the proprietary DNA-directed RNA
interference (ddRNAi) platform combining RNA interference with gene
therapy, today announced that BB-401, a gene silencing agent
comprised of plasmid DNA which produces a 39-nucleotide antisense
RNA with specificity against EGFR, is currently undergoing
evaluation in a Phase II clinical trial onto which patients with
recurrent or metastatic squamous cell carcinoma of the head and
neck have been enrolled.
Patients enrolled in the Phase II clinical trial have been
diagnosed with an advanced disease that is refractory to all
available standard therapies and must have at least one malignant
lesion that is amenable to direct injection with BB-401. An interim
analysis was recently conducted to evaluate the objective response
rate observed for the initial 12-patient cohort treated in Stage 1
of the Phase II study. Benitec's scientific and clinical teams
continue to evaluate the data derived from the interim evaluation
of the first cohort of patients treated in this Phase II
study. However, based on the initial analysis, the objective
response rate required to support continued patient enrollment into
the Phase II study was not achieved.
Benitec's scientific and clinical teams will continue with
patient follow-up for the patients treated in Stage 1 of the Phase
II study and additional details will be disclosed following the
completion of the comprehensive analyses of the clinical data
derived from ongoing patient follow-up.
There are several critical points to note regarding the
underlying nature of BB-401 as it relates to the other distinct
investigational agents in the Benitec pipeline:
- At the molecular level, all of the investigational agents that
are currently under development by Benitec are fundamentally
different from BB-401. The proprietary investigational agents under
development by Benitec employ ddRNAi which facilitates gene
silencing via the production of short hairpin RNA-based molecules
whereas BB-401 represents a modified antisense
oligonucleotide.
- All of the investigational agents that are currently under
development by Benitec function by a mechanism of action that is
completely distinct from that of BB-401 which achieves
gene-silencing via a mechanism described as post-transcriptional
interference. The proprietary ddRNAi-based agents in the Benitec
pipeline ultimately achieve gene-silencing via RNA interference
driven by activation of the RNA-Induced Silencing Complex.
- All of the investigational agents that are currently under
development by Benitec employ tissue-specific delivery vectors
(e.g. AAV9) whereas BB-401 has no delivery vector and was delivered
intratumorally as a "naked" plasmid.
About Benitec Biopharma Limited
Benitec Biopharma
Limited (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW) is a clinical-stage
biotechnology company focused on the development of novel genetic
medicines. The proprietary platform, called DNA-directed RNA
interference, or ddRNAi, combines RNA interference, or RNAi, with
gene therapy to create medicines that facilitate sustained
silencing of disease-causing genes following a single
administration. Based in Sydney,
Australia with laboratories in Hayward, California (USA), and collaborators
and licensees around the world, the Company is developing
ddRNAi-based therapeutics for chronic and life-threatening human
conditions including oculopharyngeal muscular dystrophy (OPMD),
squamous cell carcinoma of the head & neck (SCCHN),
ophthalmolgic disorders such as wet age-related macular
degeneration (AMD), and chronic hepatitis B. Benitec has also
licensed ddRNAi to other biopharmaceutical companies for
applications including HIV/AIDS, Huntington's Disease, chronic
neuropathic pain, cancer immunotherapy and retinitis
pigmentosa.
Safe Harbor Statement:
This press release contains
"forward-looking statements" within the meaning of section 27A of
the US Securities Act of 1933 and section 21E of the US Securities
Exchange Act of 1934. Any forward-looking statements that may be in
this ASX/Nasdaq announcement are subject to risks and uncertainties
relating to the difficulties in Benitec's plans to develop and
commercialise its product candidates, the timing of the initiation
and completion of preclinical and clinical trials, the timing of
patient enrolment and dosing in clinical trials, the timing of
expected regulatory filings, the clinical utility and potential
attributes and benefits of ddRNAi and Benitec's product candidates,
potential future out-licenses and collaborations, the intellectual
property position and the ability to procure additional sources of
financing. Accordingly, you should not rely on those
forward-looking statements as a prediction of actual future
results.
Australia
Investor Relations
|
United States
Investor Relations
|
Megan
Boston
Executive
Director
Benitec
Ltd
Tel: +61 400 195
388
Email:
mboston@benitec.com
|
M Group Strategic
Communications
Jay
Morakis
Managing
Director
Tel: +1 646 859
5951
Email:
jmorakis@MGroupSC.com
|
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SOURCE Benitec Biopharma