AVXT AVAX Technologies Inc (CE)

AVAX Technologies, Inc. (OTCMarket:AVXT.OB) announces the commencement of the commercial launch of M-Vax, its AC Vaccine product candidate for the treatment of melanoma, in Switzerland through its Swiss distribution partner Pro Vaccine AG based in Baar, Switzerland. Marketing of M-Vax has started after receiving authorization from the Swiss Federal Office of Public Health (FOPH) for the import and export of the product in accordance with the law for Control of Transplantation (SR 818.111) passed in March 1996. The vaccine will be produced by AVAX's wholly owned subsidiary, Genopoietic SAS, based in Lyon, France. Commenting on these international developments, Richard Rainey, President of AVAX Technologies stated: "The approval and commercial launch of M-Vax is an important milestone for AVAX, Pro Vaccine and more importantly for patients in Switzerland. With our BLA filing being evaluated by the French Regulatory Authorities and our ongoing compassionate use treatments of patients in Spain and Belgium we continue to aggressively pursue opportunities for the commercialization of the AC Vaccine in Europe. We are committed to expanding the Company's global presence in the field of cancer vaccines, and continue to pursue other international market opportunities, while we seek approval of our AC Vaccine technology in the U.S." M-Vax is the first of several autologous cell vaccines based on AVAX's proprietary AC Vaccine technology. To date over 500 patients have been treated with the AC Vaccine Technology in three different cancer indications. In addition, the safety and efficacy of M-Vax has been evaluated in over 400 patients with stage III & IV melanoma. The Company anticipates initiating additional clinical studies in the United States and France before the end of the year to evaluate the safety and efficacy of the AC Vaccine technology in patients with non-small cell lung cancer, metastatic ovarian cancer and metastatic colo-rectal cancer patients. In discussing the planned commercial activities around the launch in Switzerland, Renato Duckeck, Director of Pro Vaccine AG commented, "We are quite happy with the way opinion leaders in Switzerland have reached out to gain an understanding of the M-Vax. Of great importance were the five-year clinical results published in the Journal of Clinical Oncology in February 2004 for Stage III & IV melanoma patients. These impressive results combined with the profile of the vaccine for treating patients has sparked a great deal of interest in the vaccine." About Pro Vaccine AG Pro Vaccine AG was founded in 1995 and is a marketer and distributor of vaccines including specialized and biological vaccines. The Company was from 1996-2004 the sole distributor of all of Aventis Pasteur MSD' vaccines in Switzerland and is currently the promotional partner of Sanofi-Aventis Pharma. In addition the Company is the sole distributor in Switzerland of all vaccines of the Statens Serum Institute in Denmark and the Laboratories Thea, France. 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 Vaccine Therapeutic 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. Information for Physicians in Switzerland Investigators interested in learning more about the vaccine should contact Mrs. Sonja Wehrli at + 41 -41 769 1000. At the present time information about the commercial marketing of the vaccine is only available to healthcare professionals. 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.