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Benitec's Timetable To Success

|Includes:Benitec Biopharma Ltd (BNIKF)

It has now been three weeks since Benitec ($OTCPK:BNIKF) informed the investment community that it had started the recruitment process for its HCV clinical trial. Recruitment and screening for the two patients in cohort one should take a matter of weeks which means that in the next week or two the first patient should be dosed with TT-034.

In view of this I thought that I would publish the dosing schedule for the trial. Below is the schedule which was presented to the Recombinant DNA Advisory Committee (RAC) and I have no reason to believe that it has changed since then.

As one can see, the dosing for each cohort will be initially limited to a single patient. After positive safety data for each of the first patients, the remaining patients in the cohort will be dosed in parallel. This means that if everything progresses without a hitch, the first cohort would take twelve weeks to produce results; the second cohort would take a further twelve weeks; the third cohort would take a further twelve weeks; the forth cohort would take a further twenty weeks and the fifth cohort would conclude the trial after a further twenty weeks.

The dosing for the first two cohorts is expected to be at sub-therapeutic levels and so data from these patients is likely to be safety data only. However, even at a sub-therapeutic level, efficacy data which matched that of the non-human primate studies at similar doses would be a very good indicator of the probable success of the subsequent dosing levels.

Investors wanting a timetable to chart Benitec's success with TT-034 can plug these periods into their calendars and wait for the news to come.

Dose Escalation Scheme

Cohort

Dose (vg/kg)

Dose escalation step (log 10)

Total No subjects

Dosing scheme for subjects

Observation period per subject and between cohorts before dose escalation

1

4.00 × 1010

Starting dose

2

Sequential (1+1)

6 week

2

1.25 × 1011

0.5

3

Sequential and parallel (1+2)

6 week

3

4.00 × 1011

0.5

3

Sequential and parallel (1+2)

6 week

4

1.25 × 1012

0.5

3

Sequential and parallel (1+2)

10 weeks

5

4.00 × 1012

0.5

3

Sequential and parallel (1+2)

10 weeks

Click to enlarge

Disclosure: I am long BNIKF.

Stocks: BNIKF