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Aethlon Medical, Inc. Message Board

  • kbjameson kbjameson Aug 13, 2014 2:37 PM Flag

    Safety Study of the Aethlon Hemopurifier (AEMD-IDE-20)

    Clinicaltrial-dot-gov now has safety study registered. Identifier:NCT02215902. Starts in December.

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    • Well, I guess having this study finally show up on the government site is a positive step, but did you look at the exclusion criteria? Wow--no wonder they are projecting a year for the completion of this study. It will take that long to find ten eligible patients. This whole IDE study has become a joke, a very painful and frustrating joke. They got approval in 2013 and this study won't even begin until December of this year, and a month-long study is going to take a whole year to recruit ten patients? I think their HepC window has closed. Originally touted as an adjuvant treatment for all who had HepC, the Hemopurifier is now fairly irrelevant for this disease. Newer and better drugs have been developed, with some scientists predicting that HepC will be wiped out in the next 20 years. Now, the focus will have to be on exosomes, and I imagine we will have at least another ten years of "research" before anything tangible happens. This is not sour grapes, just calling it like I have unfortunately observed the realities. I sincerely doubt we will see the promised IND application for exosome retrieval occur this year. We always find out about the delays way after the fact. It is hard to make intelligent investing decisions when the facts are concealed or not released in a timely fashion. As recently as the last JJ interview he was saying September for the start of this 10-patient trial. Now, it is December, and I will bet that the first patient treatment won't occur until March, if then. For crying out loud, it's just a safety trial--forget the secondary endpoints--prove the safety and then move on to accomplishing other objectives. I still have my shares and will hold as long as I think there is a potential payoff, but I am so disillusioned by how this has all played out, and the release and revealing of disappointing news, always so much after the fact. Hell, wouldn't it have been easier to have set up a safety trial with 10 healthy volunteers?
      Lee

      • 3 Replies to philsdaddy
      • The safety study is not easy. The doping material, lectin is toxic to the body if it gets into the blood system. It can also create own cytokine storm. So, the processing and manufacturing of the HP units is critical to insure none of the lectin gets into the blood stream. The good thing is that the lectin works to attract and capture the virus. The product can be mass produced quickly. The shelf life testing will be the next key issue; will the micro fibers and lectins survive heat and cold exposure for long durations? The development of a small filter and pump mechanism for field use would be fantastic for the future. There also is a need to have a filter indicator that will be able to identify the actual capturing of virus while in operation. GLTYA

      • My hopes are on DARPA at this [point.
        Any news regarding HP and EBOLA with current application will send stock soaring.
        I have been watching HCV drugs coming out and see AEMD falling behind fast.
        Hope insurance companies can use HP to help lower costs (including HCV treatments).

        Sentiment: Strong Buy

      • My disappointment is simply that it's not starting until December, but perhaps they need the filters in stock for a different use.

        My understanding it that it's not a year to recruit the patients, but rather a year to complete the study. They need to test the participants in month 12 in order to determine whether a sustained virologic response (SVR) has been achieved.

 
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