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Advaxis, Inc. Message Board

  • picdoc501 picdoc501 May 14, 2012 12:49 AM Flag

    All You Need To Know (Updated Version)

    My first “All you need to know in one post” message was written over 1 year ago. It was so well received at that time that I figured it was due for an update. So here goes. Please feel free to share this information.

    Quick intro: Advaxis makes therapeutic vaccines by taking a known antigen on a cancer cell and fusing it to the LLO protein found in Listeria. The genetically engineered Listeria are then introduced intravenously into a cancer patient’s bloodstream. This is of course performed after attenuating the bacteria by 10,000 times so it is much less capable of causing disease.
    This technology is currently being tested in four phase II trials in cancers caused by the human papilloma virus (HPV). 2 trials are for late stage, recurrent cervical cancer which failed prior therapy (1 in India and 1 in the US which is sponsored by GOG, a branch of the NCI), 1 trial for CIN (the precursor to cervical cancer), and 1 trial which recently began in head and neck cancer which is sponsored by Cancer Research UK and being done totally at their own expense.

    1. Efficacy - The first and most important thing to realize is that we now have concrete evidence that this technology works. We are still in the process of finding out just how well it works…. but I can assure you…. it works. Most of the late stage cervical cancer patients are extremely sick and only expected to live 6-7 months. Phase 1, while it only had 15 patients, saw 3 patients live over 3 years, and two of these patients lived over 4 years. These last two patients may still in fact be living, but unfortunately were lost to follow up. While these numbers were incredible, they were produced on a small scale in a small sample size. The latest data from India has produced both PARTIAL AND COMPLETE responders. Some of these responders received vaccine AND chemo, while others just received the vaccine. Actual Cat Scans showing tumor reduction over time can be seen on the Advaxis website in one of the presentations. Tumor reduction charts show that tumors are slowly being “beaten down” over time… a classic response to a successful immunotherapy. And let’s not forget that a large portion of the patients without partial responses have shown stable disease…. A tremendous feat when looking at an extremely progressive cancer. The 1 years survival so far is 6 out of 15 which equals 40%. This number will be continuously updated and should get better with time…. but even if it doesn’t get better this is still a spectacular 1 year survival. The historical 1 year survival is 5%! And the best study ever done with chemo produced a 35% survival but was with a horrible side effect profile.
    Looking at the 1st arm of the CIN study (precursor to cervical cancer detected by pap smear), 53% of patients showed regression of their CIN which is considered a significant response in this lowest dose arm. There are still 2 more arms with higher doses to be tested. The second arm is complete and we should get data on that in August.
    The company is presenting at ASCO on June 3rd at which time we should receive another data update. And this update should be quite meaningful given the length of time since the last update.

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