Sydney Australia, 21 July 2014: RNAi therapeutics company Benitec Biopharma
Limited (ASX: BLT, OTC: BTEBY) is pleased to provide an update regarding
recommendations from the Data Safety Monitoring Review Board (DSMB),
observations from the first patient dosed, and patient recruitment for the USJbased
Phase I/IIa TTJ034 clinical trial. TTJ034 is a ddRNAiJbased therapeutic, designed to
treat and potentially cure hepatitis C (HCV) with a single injection.
DSMB recommendation and observations from first patient dosed
Following review of data from the first patient treated with TTJ034 on 29 May 2014,
the independent DSMB has recommended that the study can continue without
modification.
The first patient dosed in the trial has to date experienced no treatmentJrelated
adverse effects. Liver biopsy results from the first patient were encouraging and in
line with expectations. TTJ034 DNA and short hairpin RNA (shRNA) were both
detected in the biopsy at subJtherapeutic levels, indicating that liver transduction
occurred.
Trial recruitment
Benitec had expected that the second patient in the trial would be dosed on 21 July
2014. However, the trial site, Duke Clinical Research Unit (Duke), has advised the
Company that the most recent laboratory results from the next subject due to be
dosed have indicated a transient rise in the subject’s liver function enzymes. The
trial protocol dictates that this subject cannot be dosed until those results return to
acceptable levels. Accordingly, Duke is now preparing to dose the next patient on
the list of patients who have successfully passed preJscreening. Under the trial
protocol, the procedure to ensure a subject is suitable for dosing takes at least 28
days.
Benitec and University of California San Diego (UCSD) have now executed a clinical
trial agreement enabling UCSD to join Duke to concurrently screen and enrol
patients for the trial. Screening is expected to commence immediately.
More detail on the TTL034 trial
Investors are invited to review the ASX announcement of 11 July 2014 which shows
milestones for the HCV trial where updates will be made available. The HCV trial
protocol was appended to the 29 May 2014 ASX announcement.
As any other material events occur relating to the trial, Benitec will provide updates
to the market. Investors interested in tracking the progress of Benitec’s TTJ034 trial
should monitor progress via announcements lodged through the ASX.