AVXT AVAX Technologies Inc (CE)

AVAX Technologies, Inc. (OTCMarket:AVXT.OB) today announced it has filed an Investigational New Drug (IND) application with the U.S. FDA for a Phase I/II clinical trial treating patients with Stage I, and II Non-Small Cell Lung Cancer (NSCLC). The study will utilize AVAX's AC Vaccine Therapeutic that will be given as a first line treatment after surgery. The study endpoints include safety and a measure of cellular immunity - delayed-type hypersensitivity (DTH) to the patient's own (autologous) lung cancer cells. David Berd, MD, Chief Medical Officer of AVAX stated, "We are happy to have submitted this IND and look forward to working with the University of Pennsylvania to begin the study and to be able to offer NSCLC patients a potential new treatment. With this indication, and the ongoing studies treating melanoma in the United States and metastatic peritoneal cancer in France, we are confident we will be able to demonstrate the utility of the AC Vaccine Therapeutic as a platform technology." Berd added "Based upon previous observations of regression of melanoma lung metastases after administration of M-Vax, our AC Vaccine Therapeutic for the treatment of melanoma, we feel there is a strong rationale for testing the vaccine in this indication. Moreover, the fact that NSCLC is a chemically-induced cancer makes it likely to be immunogenic and responsive to appropriate immunotherapy." Richard Rainey, President of AVAX stated: "Given our previous findings in lung metastases, the potential to utilize the AC Vaccine in NSCLC represents a significant step in AVAX's corporate strategy. NSCLC is a terribly common disease with about 175,000 new cases per year in the United States and a similar number in Europe. About 25% of these are stage I or II patients that could be candidates for our vaccine approach." Rainey added: "This trial represents a significant advance for AVAX. By the end of this year we will be treating patients in three separate cancer indications and we will have treated more patients with M-Vax than in any previous year of the Company's history." During June 2005, AVAX initiated enrollment of patients into its melanoma study. Currently there are two sites accruing patients and two more that will be initiated in the coming week. Three additional sites are expected to be operational in September. In addition, the Company continues to make M-Vax available to patients in Europe on a compassionate use basis. M-Vax is distributed in Europe through GROUPO FERRAR, S.A. Information for Patients Patients and clinicians interested in learning more about the current clinical trial of melanoma or who want a list of the participating sites may contact Dr. David Berd at (215) 241-9760 X1306. 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 treatment for cancer. In addition, the Company performs contract-manufacturing services for biological products to other pharmaceutical and biotechnology companies. The AC Vaccines therapeutic is 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 DTH. A previously published article in the Journal of Clinical Oncology, February 2004 reported actual five-year survival data for a group of 214 patients with clinically evident Stage III melanoma treated with the AC Vaccine following surgery. The study demonstrated five-year survival of 45% and showed a highly statistically significant relationship between survival and DTH to patients' own tumor cells. Notably, based upon these results, DTH appears to be a viable "surrogate marker" for survival and an early indicator for clinical effectiveness of current and future product candidates. Previously clinical trials in ovarian and renal cell carcinoma, demonstrated strong DTH responses consistent with those reported for melanoma patients. 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) the results of clinical and laboratory testing of its vaccine technologies, (2) possible future FDA or AFSSAPS questions regarding the Company's products and manufacturing processes, (3) the Company's need for additional capital in the future to continue its development programs, (4) the Company's ability to maintain its rights under license agreements and to meet funding requirements under its license agreements, (5) 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, (6) the Company's ability to manufacture, receive and ship its vaccine products for clinical and commercial distribution, 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 for the year ended December 31, 2004. AVAX does not undertake any obligation to release publicly any revisions to these forward-looking statements or to reflect the occurrence of unanticipated events.