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NW Bio Responds To Shareholder Inquiries Following Immune Therapy Sector's Recent Market Decline
Date:12/16/2013

n tumor.  This provides assurance that the antigen targets, which DCVax mobilizes the patient's immune system to hit, are actually on that patient's version of the cancer.  In contrast, the six antigens used in the Competitor's technology are pre-selected standardized antigens that may or may not be expressed, in whole or in part, on a given patient's version of GBM brain cancer.  The scientific literature has established that GBM is highly variable from patient to patient.

Experience Differences.  NW Bio's DCVax platform technology has been applied in two prior Phase I/II clinical trials for GBM, a small Phase I trial in metastatic ovarian cancer, a Phase I/II trial in late stage prostate cancer, a large number (over 100) prostate cancer patients in an academic setting, and a number of diverse compassionate use cases, over the course of more than ten years of clinical development.  The Competitor's technology had only previously been applied in one Phase I trial with 16 patients.

Clinical Trial Differences.  NW Bio is well under way with a 312-patient Phase III clinical trial.  The trial has been approved by three separate, highly rigorous regulators:  in the US, UK and Germany.  The DCVax technology and the Phase III trial have been evaluated by the National Health System (NIHR) in the UK and "adopted" as a nationwide priority in the UK.  NW Bio's Phase III trial is robustly designed.  If the primary endpoint is met, it is anticipated that this may result in a p value of 0.01 one-sided (0.02 two-sided), with a power of 82%.  A two-sided p value of 0.02 is well below (and hence stronger than) the p value of 0.05 which is generally needed for statistical significance.  Such a p value would provide a substantial cushion in case the difference in PFS turns out to be less than was projected in determining the statistical powering in the design of the trial. 
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