AVAX Presents Results of a Dose-Response Study of MVax(R) at American Society of Clinical Oncology (ASCO)

  
    
  
  
    
      AVAX Technologies, Inc. (OTC Market: AVXT.OB) presented the results of 
      its phase I-II trial of MVax®, its 
      autologous, hapten-modified melanoma vaccine, at the annual meeting of 
      the American Society for Clinical Oncology (ASCO) at a poster session 
      held Sunday, June 1.
    
    
      The presentation, entitled, “Dose-response 
      study of a cryopreserved, autologous, hapten-modified melanoma vaccine 
      (MVax®),” analyzed 
      the safety and immunological efficacy of MVax in 82 patients with Stage 
      III or IV metastatic melanoma. Patients were blindly assigned to one of 
      four dosage groups: 5 million, 2.5 million, 0.5 million or zero (control 
      arm) melanoma cells per dose. In all groups MVax was administered 
      according to a previously defined optimum treatment schedule. The 
      immunological endpoint was the development of delayed-type 
      hypersensitivity (DTH) to autologous, hapten-modified melanoma cells. 
      DTH is a measure of immunity, which AVAX believes is a surrogate marker 
      of MVax’s efficacy. All eligible patients had 
      negative DTH prior to MVax administration.
    
    
      Using a Simon, two-stage analysis the high dose arm (5 million cells) 
      was effective: 23/30 patients developed positive DTH to autologous, 
      DNP-modified melanoma cells and 9/25 to autologous, unmodified melanoma 
      cells. These proportions of positive responses were statistically 
      indistinguishable from the DTH response rate observed in previous 
      studies of MVax conducted at Thomas Jefferson University. In contrast, 
      the zero and medium doses were ineffective, and the low dose was 
      borderline. Moreover, a plot of the dose of MVax administered versus the 
      intensity of the DTH response induced showed a strong correlation: the 
      higher the dose, the larger the DTH.
    
    
      “This study provides critical information 
      about the lower end of the MVax dose-response curve,” 
      commented David Berd, Chief Medical Officer of AVAX. “It 
      allows us to rationally set the dose for phase III, which is 8 to 20 
      million cells. In addition, it forms a bridge to previous studies of 
      MVax that were performed in more than 400 patients at Jefferson over the 
      past 15 years.”
    
    
      As expected, MVax had an excellent safety profile. Adverse events were 
      identical to what was observed in previous trials and no serious adverse 
      events related to MVAX were observed.
    
    
      MVax® Phase III Registration Study – 
      MVALDI trial
    
    
      AVAX’s ongoing Phase III Registration, MVALDI 
      trial examines survival and anti-tumor response rate using modified 
      response evaluation criteria in solid tumors (modified RECIST 
      criteria) in Stage IV melanoma patients with soft tissue or lung 
      metastasis. The Phase III registration trial is being conducted under a 
      Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug 
      Administration (FDA) for MVax® and in 
      agreement with the FDA the company will be eligible to file for 
      accelerated approval of MVax® based upon 
      achieving a response rate endpoint. The double blind, randomized trial 
      is expected to enroll up to 387 patients to be accrued over a period of 
      24 months. Patients are randomized on a two to one basis to the 
      treatment arm or control arm, respectively. The treatment arm consists 
      of MVax followed by a regimen of low dose IL-2; the control arm consists 
      of placebo vaccine followed by low dose IL-2. Both treatment and control 
      arms include BCG and low dose cyclophosphamide.
    
    
      MVax® in Metastatic Melanoma
    
    
      In a phase 2 clinical study published in the International Journal of 
      Cancer, MVax® induced tumor shrinkage in 
      11/83 patients with surgically incurable stage IV melanoma. In a 
      subsequent paper published by Dr. Michal Lotem in the British Journal of 
      Cancer (British Journal of Cancer 2004, 90 773-780) patients treated 
      with their DNP modified tumor cells, using manufacturing techniques 
      similar to MVax®, followed by administration 
      of low dose interleukin-2, achieved a response rate of 35%. These 
      results were confirmed in a subsequent study conducted by the same 
      investigator that showed a 32% response rate, including 13% complete 
      responses and 19% partial responses.
    
    
      MVax® in Stage III Melanoma
    
    
      MVax® was the subject of a publication in the 
      Journal of Clinical Oncology that discussed 214 Stage III melanoma 
      patients that were treated with a regimen of MVax® 
      post surgery. No patients were lost to follow-up and they were split 
      between Stage IIIb & Stage IIIc melanoma. All patients on study had 
      completed follow-up and the reported five-year survival rate was 45%. 
      This compares to five-year survival published in similar patient 
      populations who underwent surgery alone of 22%. In addition, the data 
      showed a significant correlation between survival and delayed-type 
      hypersensitivity (DTH) responsiveness to patients’ 
      unmodified tumor cells (P