AVAX Technologies Announces Initiation of Clinical Study with Autologous Ovarian Cancer Vaccine

Business Wire, April 9, 2008

Study to be conducted with Cancer Treatment Centers of America pursuant to a $1.2M business collaboration

PHILADELPHIA -- 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.