AVAX Technologies Announces Initiation of Clinical Study with Autologous Ovarian Cancer Vaccine (OVax(R))

  
    
  
  
    
      AVAX Technologies, Inc. (OTC Market:AVXT.OB) today announces it has 
      received FDA approval to begin enrollment into a Phase I-II clinical 
      trial of OVax for patients with advanced, chemotherapy-refractive 
      ovarian cancer. The study will be performed in collaboration with Cancer 
      Treatment Centers of America, Inc (CTCA). It will be centered in the 
      CTCA hospital in Zion, Illinois, although patients also will be referred 
      from other CTCA hospitals in Tulsa and Philadelphia, and its out-patient 
      clinic in Seattle.
    
    
      Up to 42 eligible patients with stage III or IV ovarian carcinoma will 
      be enrolled. These patients’ cancers will have 
      progressed despite initial surgery and chemotherapy and failed to 
      respond to one or two salvage chemotherapy regimens. They will undergo 
      debulking surgery, and tumor tissue will be sent to AVAX for production 
      of vaccine. Post-operatively, they will receive intraperitoneal 
      chemotherapy with a taxane and then will be enrolled into the protocol.
    
    
      Three doses of OVax will be tested, and each of the three doses will be 
      analyzed for immunological efficacy with the goal of optimizing the dose 
      for treatment of patients in future trials.
    
    
      “We are enthusiastic about receiving FDA 
      clearance to start this important clinical trial and with the 
      opportunity it affords us to collaborate with CTCA,” 
      stated Dr. David Berd, Chief Medical Officer of AVAX. “Clearly, 
      better treatments for ovarian cancer are needed and we hope that OVax 
      will eventually find its place as a relatively non-toxic therapeutic 
      alternative for these patients. This alliance with CTCA will allow us to 
      expand the therapeutic utility of the AC Vaccine platform along with our 
      ongoing Phase I/II program in non-small cell lung cancer and our 
      recently launched Phase III pivotal registration study in melanoma 
      (MVALDI).”
    
    
      As part of the business collaboration CTCA has made an up-front payment 
      of $250,000 and will begin to make monthly payments of $25,000 upon the 
      initiation of production of vaccines at AVAX’s 
      Philadelphia manufacturing facility.
    
    
      “We are very excited to be part of a new 
      chapter in the fight against ovarian cancer,” 
      said Dr. Edgar Staren, Chief Medical Officer at Cancer Treatment Centers 
      of America. “Ovarian cancer is a very complex 
      cancer that is often resistant to chemotherapy, radiation and surgery. 
      At Cancer Treatment Centers of America, our commitment to cancer 
      patients is to help fight their cancer with the most advanced medical 
      technology available. This partnership with AVAX gives hope to ovarian 
      cancer patients who are told far too often that there is nothing more 
      that can be done for them. This treatment option will work well with our 
      unique integrative care model that combines state-of-the-art traditional 
      medicine with scientifically-based complementary therapies such as 
      aggressive nutritional management and support, naturopathic medicine, 
      physical therapy, mind-body medicine and spiritual support to go beyond 
      treating the tumor and supporting the needs of the whole person – 
      all under one roof.”
    
    
      About the AC Vaccine Therapeutic
    
    
      The AC Vaccine is an immunotherapy prepared by attaching a small 
      chemical to the patient’s tumor cells in a 
      process known as haptenization. This hapten modification allows the 
      tumor cells to stimulate a T cell-based immune response to a patients 
      own tumor cells. An early indicator of T cell immune activity is Delayed 
      Type Hypersensitivity (DTH).
    
    
      An understanding of what AVAX calls the immunopharmacology of the AC 
      Vaccines is critical to their effective use. AVAX believes that the 
      optimal dose, schedule of administration, and route of administration of 
      human cancer vaccines must be established before they enter advanced 
      phase studies, and that some competing vaccine technologies have failed 
      because their developers ignored one or more of these parameters in 
      early phase development. The optimum schedule and best route of 
      administration (intradermal) to be used for OVax were determined by 
      extensive phase I-II studies of MVax. The latest phase I-II trial was 
      completed last year and the results will be presented at the 2008 
      meeting of the American Society of Clinical Oncology (ASCO).
    
    
      MVax Phase III Registration Study
    
    
      AVAX’s Phase III Registration, MVALDI Trial 
      will examine 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 will be 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 interleukin-2 (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.
    
    
      About Ovarian Cancer
    
    
      The American Cancer Society reports that ovarian cancer is the eighth 
      most common cancer among women and is the fifth leading cause of cancer 
      related deaths in women. It is estimated that there will be 21,650 new 
      cases of ovarian caner in the U.S. in 2008 and 15,520 cancer related 
      deaths. Two-thirds of the cases of Ovarian Cancer will occur in women 
      over 55.
    
    
      About Cancer Treatment Centers of America
    
    
      Founded in 1988, Cancer Treatment Centers of America (CTCA) provides a 
      comprehensive, patient-centered treatment model that fully integrates 
      traditional, state-of-the-art medical treatments with 
      scientifically-supported complementary therapies such as nutrition, 
      naturopathic medicine, psycho-social counseling, physical therapy and 
      spiritual support to meet the special, whole-person needs of cancer 
      patients living with complex and advanced-stage disease. With a network 
      of cancer treatment hospitals and community oncology programs in 
      Illinois, Oklahoma, Pennsylvania and Washington, CTCA encourages 
      patients and their families to participate in treatment decisions with 
      its Patient Empowerment MedicineSM model. For 
      more information about Cancer Treatment Centers of America, go to 
      cancercenter.com.
    
    
      About AVAX Technologies, Inc.
    
    
      AVAX Technologies, Inc. is a biotechnology company with operations in 
      the United States and Europe. The Company is engaged in the research, 
      clinical and commercial development of biological products and cancer 
      therapeutics. AVAX’s AC Vaccine platform is a 
      therapeutic cancer vaccine. In addition, the Company performs 
      contract-manufacturing services for biological products for other 
      pharmaceutical and biotechnology companies.
    
    
      Except for statements that are historical, the statements in this 
      release are "forward-looking" statements that are made pursuant to the 
      safe harbor provisions of Section 27A of the Securities Act of 1933 and 
      Section 21E of the Securities Exchange Act of 1934. Forward-looking 
      statements involve significant risks and uncertainties, and in light of 
      the significant uncertainties inherent in such statements, the inclusion 
      of such information should not be regarded as a representation by AVAX 
      that the objectives and plans of the Company will be achieved. In fact, 
      actual results could differ materially from those contemplated by such 
      forward-looking statements. Many important factors affect the Company's 
      prospects, including (1) risk associated with a change in executive 
      management of the Company, (2) the immediate need to obtain additional 
      funding to continue to finance the Company’s 
      development plans, including the Phase I-II clinical trial for OVax 
      described in this press release, (3) the results of clinical and 
      laboratory testing of its vaccine technologies, (4) possible future FDA 
      or AFSSAPS questions regarding the Company's products and manufacturing 
      processes, (5) exchange rate risks associated with financing the Company 
      in U.S. dollars but funding significant operating expenses in Europe 
      with Euro’s, (6) the Company's ability to 
      maintain its rights under license agreements and to meet funding 
      requirements under its license agreements, (7) the Company's ability to 
      demonstrate the safety and efficacy of product candidates at each stage 
      of development and to meet applicable regulatory standards and receive 
      required regulatory approvals, as well as other risks detailed from time 
      to time in AVAX's public disclosure filings with the Securities and 
      Exchange Commission, including its Annual Report on Form 10-KSB. AVAX 
      does not undertake any obligation to release publicly any revisions to 
      these forward-looking statements or to reflect the occurrence of 
      unanticipated events.