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Pannobhaso
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A researcher into gene silencing as a technology for improving the lives of those suffering from incurable diseases. Benitec Biopharma is my primary investment in this technology as ddRNAi offers one-time treatments for a broad range of these diseases.
  • Benitec's Timetable To Success 4 comments
    Feb 3, 2014 10:07 PM | about stocks: 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

    Disclosure: I am long BNIKF.

    Themes: ddRNAi, Benitec, shrna, TT-034, HCV Stocks: BNIKF
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Comments (4)
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  • subrkaus3
    , contributor
    Comments (81) | Send Message
     
    When can we actually start to get data from the P1 trials? do they need any capital raise this year. appreciate your thoughts on Benitec.
    3 Feb, 10:26 PM Reply Like
  • Cynical Trader
    , contributor
    Comments (14) | Send Message
     
    Pannobhaso, I've been following your blog articles and comments. I appreciate your in depth knowledge of Benitec's platform. Question... where can I find data from the NHP studies?
    3 Feb, 11:06 PM Reply Like
  • Pannobhaso
    , contributor
    Comments (107) | Send Message
     
    Author’s reply » CT, here are some references that you may find useful.

     

    http://1.usa.gov/1cQYl7B

     

    http://bit.ly/1cQYl7D

     

    http://bit.ly/1cQYo3n

     

    There is another paper which is due to be published later this month or early next month. When it is available I will reference it here on SA.
    4 Feb, 11:06 AM Reply Like
  • Pannobhaso
    , contributor
    Comments (107) | Send Message
     
    Author’s reply » subrkaus, the TT-034 trial is a Pl/lla trial, which means it is a small trial that addresses both safety and efficacy. The first safety data is likely to be released within two or three weeks after the completion of monitoring of the first cohort i.e., about 14-15 weeks after the first patient is dosed.

     

    I am sure that efficacy data will be released at a time most suited to the company. As the first two cohorts are being dosed at a level that is probably going to be sub-therapeutic, Benitec may wait until the results of the third cohort are know. As I said in the blog, if early efficacy results mirror those of the non-human primates, then results could be published at an early date.
    4 Feb, 10:55 AM Reply Like
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