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Advaxis, Inc. Message Board

  • aime5pierre aime5pierre Oct 21, 2013 10:06 PM Flag

    Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

    Further study details as provided by Gynecologic Oncology Group:
    Just a reminder:
    Official Title: A Phase II Evaluation of ADXS11-001 (NSC 752718, BB-IND#13,712) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix

    Primary Outcome Measures:
    Number of patients with dose-limiting toxicities [ Designated as safety issue: Yes ]
    Frequency and severity of adverse effects as assessed by CTCAE v 4.0 [ Designated as safety issue: Yes ]
    Proportion of patients who survive for at least 12 months [ Designated as safety issue: No ]

    Secondary Outcome Measures:
    Distribution of overall survival [ Designated as safety issue: No ]
    Distribution of progression-free survival [ Designated as safety issue: No ]
    Proportion of patients who have objective tumor response (complete or partial) [ Designated as safety issue: No ]

    Estimated Enrollment: 67
    Study Start Date: September 2011
    Estimated Primary Completion Date: OCTOBER 2013 (Final data collection date for primary outcome measure)

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    • Yes, it all sounds great. But watch the greed. I am going to hold, wait, and sell after an increase of a few dollars. They have a market cap of 20 mil. That's nothing. Do you know how much it will cost to develop the immune-therapy and get it into an FDA approved human clinical trial? 20 mil is a drop, so we are looking at years of multiple dilutions. It will go up, on good news, and then crash on dilution, and so on.... Unless they hit a problem with the actual treatment.

      Sentiment: Hold

    • From SEC document 424B5 dated 10/17/13...
      "The GOG of the NCI is conducting a study in
      67 patients with recurrent/refractory cervical cancer. As of
      September 2013, 13 patients have been enrolled in the safety runin
      portion of the study. The study is open group wide to the
      GOG."
      =====
      So, 13 patients have been enrolled in the safety runin portion of the study and they are showing Estimated Primary Completion date of THIS month (October 2013.)

      From Clinicaltrials(dot)gove website...
      "Primary Outcome Measures:
      •Number of patients with dose-limiting toxicities [ Designated as safety issue: Yes ]
      •Frequency and severity of adverse effects as assessed by CTCAE v 4.0 [ Designated as safety issue: Yes ]
      •Proportion of patients who survive for at least 12 months [ Designated as safety issue: No ]

      I wonder if this means we will be receiving some news here on the Primary Outcome Measure very soon.

 
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