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  • Advaxis, Inc. (ADXS) Encouraged By Preliminary Data From Penn Phase 1 ADXS-cHER2 Canine Osteosarcoma Study 0 comments
    Apr 29, 2013 10:43 AM | about stocks: ADXS

    Advaxis, Inc. (NASDAQ:ADXS) Encouraged by Preliminary Data from Penn Phase 1 ADXS-cHER2 Canine Osteosarcoma Study

    Advaxis, a clinical-stage biotech company developing immunotherapies for cancer and infectious diseases, today told investors of encouraging preliminary data from the Phase 1 dose escalation study evaluating the safety of ADXS-cHER2 in companion dogs with Her2/neu overexpressing canine osteosarcoma being conducted at the University of Pennsylvania School of Veterinary Medicine.

    The primary goal of the study is to establish the maximum tolerated dose of ADXS-cHER2. Preliminary data from the first two dose groups (3 dogs each) show that ADXS-cHER2 at either 1 x 10(8) or 5 x 10(8) cfu is well-tolerated. 100% of dogs experienced 1 or more mild (Grade 1) side effects consistent with cytokine release syndrome observed at the time of administration (fever, increased blood pressure, malaise, nausea, and/or vomiting). Early data also suggest that Her2/neu expression in canine osteosarcoma may denote a more aggressive phenotype.

    The study is also being used to determine progression-free survival and overall survival. Early results from the first two dose groups (6 dogs) show a significant survival advantage in dogs that received ADXS-cHER2 compared to 6 dogs whose owners elected not to participate in the trial but who were followed for survival (p=0.01).

    Dr. Nicola Mason, lead investigator in the Penn canine osteosarcoma study, plans to expand the trial to three additional sites in the United States. ADXS-cHER2 booster vaccinations will be given to evaluate the effects of maintenance immunotherapy.

    "The preliminary data from this study are encouraging," stated Dr. Nicola Mason. "The dogs that have been treated with ADXS-cHER2 are doing very well and although the numbers of vaccinated dogs are small, they do appear to be doing better than dogs with Her2/neu overexpressing tumors that did not receive the vaccine. I am extremely excited to expand this trial, make the vaccine available to more dogs, and determine its therapeutic benefit in dogs with this highly aggressive tumor type."

    "These preliminary findings suggest that the second Advaxis immunotherapy to be evaluated in a clinical setting (in addition to ADXS-HPV) may also improve survival in cancer. Furthermore, a veterinary oncology indication could potentially open an entirely new market for Advaxis Lm-LLO immunotherapies and further validates the versatility of our technology platform and constructs," commented Thomas A. Moore, Chairman and Chief Executive Officer of Advaxis.

    For more information, visit Advaxis.com

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    Stocks: ADXS
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