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Inovio Pharmaceuticals, Inc. Message Board

  • dnwang dnwang Mar 22, 2013 11:55 AM Flag

    My thinking about Chrontech Hep. C PII data

    Maybe I am wrong but I think data is negative. We'll see....

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    • The data in the 10K was from preclinical safety (monkeys) and the dose ranging study, per:

      "Subsequent to year end we announced positive preclinical results from this proprietary HCV vaccine, which were published in Molecular Therapy. This synthetic multi-antigen DNA vaccine covers hepatitis C virus genotypes 1a and 1b and targets the antigens NS3/4A, which includes HCV nonstructural proteins 3 (NS3) and 4A (NS4A), as well as NS4B and NS5A proteins. Following immunization, rhesus macaques mounted strong HCV-specific T cell immune responses strikingly similar to those reported in patients who have cleared the virus on their own. The responses included strong NS3-specific interferon-ã (IFN-ã) induction, robust CD4 and CD8 T cell proliferation, and induction of polyfunctional T cells.

      Under a 2011 development agreement, VGX International will fully fund IND-enabling, phase I, and phase II studies for this vaccine. The companies intend to initiate a phase I/IIa clinical study in the second half of 2013."

      Now in completing the Phase IIa (dose ranging study) if they got the same response in humans as they did in monkeys, that would be positive data. Is that what is being suggested? Among the 32 persons in the study, there were 20 that got multiple doses of the vaccine and 12 who received placebo (Control group). Theoretically, the 20 would/could have developed antibody and a T-cell mediator response similar to the monkeys. If they did, that response is on track for the Phase IIb (Phase III enabling) clinical trial. Please note, if in the Phase IIb trial the antibody and T-cell responses remedy the onset or progression of the Hep C, the FDA has the option of expediting the filing of the BLA. But as was said in this thread, we shall see.

      Sentiment: Strong Buy

      • 1 Reply to rehdvm2004
      • Obviously this poster is talking about vgx-8000. Not Chronvac C. You seem to have left out this paragraph;

        Additionally, in April 2010, we announced, along with our collaborators from Drexel University, Cheyney University, and the University of Pennsylvania, that we received a combined $2.8 million grant to advance our proprietary synthetic vaccine to treat HCV using our electroporation delivery system. The grant funded pre-clinical studies using an expanded set of SynCon® immunogens to test the safety and effect on the immune system of our novel vaccines designed to treat persons who are chronically infected with HCV and have not responded to currently available therapies.

        Which is just below the paragraph about ChronVac C. Mistake or imposter? Please clarify

    • Confucius say positive.

    • What data? I just checked at clinical trials DOT gov and it says the study is still recruiting. The following study number leads directly to that study: ClinicalTrialsDOTgov Identifier: NCT01335711.

      Are you referring to comments in the 10Q, or whatever document that might be?

      Sentiment: Strong Buy

 
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