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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.
  • Calimmune: Good Safety Results 12 comments
    Mar 23, 2014 3:15 AM | about stocks: BNIKF

    While Benitec (OTCPK:BNIKF) licensee, Calimmune, has be reluctant to publish news on its HIV clinical trial, the news on the street is that the initial safety results from the first cohort are good. This backs up a comment made in a statement from the CIRM which was issued at the beginning of the year and indicated that no safety issued had been experienced to-date.

    The word is that the FDA initially only allowed the company to screen trial applicants one at a time. So, despite the fact that this trial commenced in June 2013, it took several months to find all the patients required to complete the first cohort. This limitation has now been removed and the company is free to do multiple screenings simultaneously.

    The news is that the second cohort is due to start dosing very soon. The FDA protocols would required the second cohort only be dosed if the safety profile from the first cohort met to trial criteria. It can therefore be inferred that the safety results for Cal-1 are good. This is particularly important in this trial as all the cohorts are to receive the same dose of Cal-1.

    Of course, we will have to wait for official results to see an impact on Benitec's share price but I think we can assume that the impact is going to be positive, very positive.

    Disclosure: I am long BNIKF.

    Additional disclosure: The views expressed here do not represent investment advice.

    Stocks: BNIKF
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Comments (12)
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  • Avid Research
    , contributor
    Comments (23) | Send Message
     
    Do u think we will see any results from Calimmune this year from cohort 1? It almost looks like we will have to wait a full year until CROI 2015 unless there are other conferences in 2014 suited for this data update?
    23 Mar 2014, 01:05 PM Reply Like
  • Pannobhaso
    , contributor
    Comments (242) | Send Message
     
    Author’s reply » Calimmune is a private company and so they can please themselves as to when they release information. Their track record would indicated that they will be very conservative when it comes to making announcements. That said, if results are as good as expected and the company is looking for a partner, we could see some early data released. As I understand it, they will publish at least one more pre-clinical paper before any safety data is produced.
    23 Mar 2014, 08:12 PM Reply Like
  • GrowthGeek
    , contributor
    Comments (2774) | Send Message
     
    It looks as if the news from Calimmune is driving BNIKF sharply upwards today as most of the biotech world is taking a beating.
    Benitec has already had great results in 2014 and there is a lot of room for upward movement left.
    24 Mar 2014, 01:45 PM Reply Like
  • Pannobhaso
    , contributor
    Comments (242) | Send Message
     
    Author’s reply » Calimmune now has some ddRNAi/HIV competition as the City of Hope trial, to which I have referred previously, has now started to recruit patients.

     

    http://1.usa.gov/1gwj42g

     

    When the team of Prof Berhout in the Netherlands gets into the clinic, there will be three teams all using ddRNAi in different ways to find a cure for HIV.
    27 Mar 2014, 11:26 PM Reply Like
  • subrkaus3
    , contributor
    Comments (98) | Send Message
     
    As usual good info Panno!
    28 Mar 2014, 02:42 AM Reply Like
  • Pannobhaso
    , contributor
    Comments (242) | Send Message
     
    Author’s reply » For anyone interested in the science, a related, pre-clinical paper by Calimmune's partner, UCLA has been published in the journal Cell, Stem Cells.

     

    http://bit.ly/PryUB0

     

    What this means is that, in monkeys, modified blood stem cells can continue to replicate for ten years or more. The key to the success of the current trial is therefore the number of stems cell which can be transduced with the modified CCR5 shrna compound before they are re-injected into the patient.

     

    When Calimmune does finally release some safety data from the trial, all interested Benitec shareholders should look to see if a transduction rate is mentioned. We would want it to be above 30%, preferably above 40%, and if it is, then, there is a good chance that the trial will be successful.
    4 Apr 2014, 10:19 AM Reply Like
  • subrkaus3
    , contributor
    Comments (98) | Send Message
     
    Panno, totally agree with you!
    4 Apr 2014, 10:44 AM Reply Like
  • Pannobhaso
    , contributor
    Comments (242) | Send Message
     
    Author’s reply » For those interested in the Calimmune trial, you may want to check out this tumblr site. It belongs to one of the first recipients of Cal-1. As he seems to be enjoying life as much as he can, I think it proves the points that were rumored in the initial article. The link is to specific references to Calimmune, including a photo of the IV bag that was used to introduce his modified blood cells.

     

    http://bit.ly/Rex3jr
    3 May 2014, 07:34 AM Reply Like
  • brama66
    , contributor
    Comments (171) | Send Message
     
    Awesome, thanks Panno!
    5 May 2014, 12:46 PM Reply Like
  • Pannobhaso
    , contributor
    Comments (242) | Send Message
     
    Author’s reply » It seems that Calimmune is starting to gear up for an expansion of its HIV Cal-1 trial because it is advertising for a clinical trial manager in Australia. The company has already flagged that part of its expansion is to be Australia and so, again, this information points to the early safety profile for Cal-1 being positive. It also indicates that they have enough capital to undertake this expansion.

     

    http://bit.ly/1g5gsVx
    6 May 2014, 09:31 AM Reply Like
  • Pannobhaso
    , contributor
    Comments (242) | Send Message
     
    Author’s reply » Calimmune has recently contributed to research where mathematical models were used to simulate its method for treating HIV. The models seem to support the pre-clinical work done by the company and confirm that, if sufficient genetically modified CD34+ HSC cells can be re-introduced into the patient, they will provide at least a ten year (extent of model) therapeutic effect against HIV.

     

    I think that the company would be feeling quietly confident that it can meet the parameters used in the model and can therefore have even greater confidence that it will succeed in delivering a therapy for HIV.

     

    If they can do this, it will also be a home run for Benitec.

     

    http://bit.ly/1m29eYA)
    20 Jun 2014, 12:53 AM Reply Like
  • J8
    , contributor
    Comments (43) | Send Message
     
    Tye Olsen (interview on YouTube video) said he was "undetectable" straight away.
    20 Jun 2014, 06:42 PM Reply Like
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