AVXT AVAX Technologies Inc (CE)

AVAX Technologies, Inc. (OTCMarket: AVXT.OB) today announces that enrollment is commencing for its Phase I/II study in patients with Non-Small Cell Lung Cancer. The study will enroll patients with surgically resectable non-small cell lung cancer for adjuvant treatment with AVAX's AC Vaccine technology. The vaccine is composed of tumor cells obtained from each patient's tumor that are modified with the hapten, dinitrophenyl (DNP). Endpoints of the study include safety and a measure of each patient's immune response to their cancer after vaccination using a delayed-type hypersensitivity (DTH) test. David Berd, MD, Chief Medical Officer of AVAX stated, "We are pleased to initiate this important study and we are looking forward to obtaining the first data on immunological responses from the study early this year. 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 plus initial results obtained in our animal model, we feel there is a strong rationale for testing the vaccine in lung cancer. Moreover, the fact that NSCLC is a chemically-induced cancer makes it likely to be immunogenic and responsive to appropriate immunotherapy." The study will include patients whose lung cancers are completely resectable. They will be assigned to one of three vaccine doses, and the dose is measured by the number of cancer cells. Each dosage arm will include a maximum of 14 patients. The study subjects will receive vaccine treatment immediately after surgery and prior to any other adjuvant treatment. Based upon anticipated enrollment the Company expects to obtain initial immunological data from the study in the second quarter of 2006. Lung Cancer Lung cancer is the leading killer of men and women. In the United States in 2002 it is estimated 169,400 new cases and 154,900 deaths from lung cancer. There are two major types of lung cancer, non small cell lung cancer, which accounts for about 80% of the cases of lung cancer, and small cell lung cancer, which comprises the other 20%. About 25% of patients with non-small cell lung cancers are surgically resectable. Information for Patients and Clinicians Patients and clinicians interested in learning more about the current clinical trial may contact Dr. David Berd AVAX Technologies 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.