10.10.2005 12:40:00
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AVAX Technologies Announces the Launch of M-Vax For the Treatment of Patients With Stage III & IV Melanoma in Switzerland; Pro Vaccine AG Commences Commercial Launch in Switzerland
Commenting on these international developments, Richard Rainey,President of AVAX Technologies stated: "The approval and commerciallaunch of M-Vax is an important milestone for AVAX, Pro Vaccine andmore importantly for patients in Switzerland. With our BLA filingbeing evaluated by the French Regulatory Authorities and our ongoingcompassionate use treatments of patients in Spain and Belgium wecontinue to aggressively pursue opportunities for thecommercialization of the AC Vaccine in Europe. We are committed toexpanding the Company's global presence in the field of cancervaccines, and continue to pursue other international marketopportunities, while we seek approval of our AC Vaccine technology inthe U.S."
M-Vax is the first of several autologous cell vaccines based onAVAX's proprietary AC Vaccine technology. To date over 500 patientshave been treated with the AC Vaccine Technology in three differentcancer indications. In addition, the safety and efficacy of M-Vax hasbeen evaluated in over 400 patients with stage III & IV melanoma. TheCompany anticipates initiating additional clinical studies in theUnited States and France before the end of the year to evaluate thesafety and efficacy of the AC Vaccine technology in patients withnon-small cell lung cancer, metastatic ovarian cancer and metastaticcolo-rectal cancer patients.
In discussing the planned commercial activities around the launchin Switzerland, Renato Duckeck, Director of Pro Vaccine AG commented,"We are quite happy with the way opinion leaders in Switzerland havereached out to gain an understanding of the M-Vax. Of great importancewere the five-year clinical results published in the Journal ofClinical Oncology in February 2004 for Stage III & IV melanomapatients. These impressive results combined with the profile of thevaccine for treating patients has sparked a great deal of interest inthe vaccine."
About Pro Vaccine AG
Pro Vaccine AG was founded in 1995 and is a marketer anddistributor of vaccines including specialized and biological vaccines.The Company was from 1996-2004 the sole distributor of all of AventisPasteur MSD' vaccines in Switzerland and is currently the promotionalpartner of Sanofi-Aventis Pharma. In addition the Company is the soledistributor in Switzerland of all vaccines of the Statens SerumInstitute in Denmark and the Laboratories Thea, France.
About AVAX Technologies, Inc.
AVAX Technologies, Inc. is a biotechnology company with operationsin the United States and Europe. The Company is engaged in theresearch, clinical and commercial development of biological productsand cancer therapeutics. AVAX's AC Vaccine platform is a therapeutictreatment for cancer. In addition, the Company performscontract-manufacturing services for biological products to otherpharmaceutical and biotechnology companies.
The AC Vaccine Therapeutic
The AC Vaccines therapeutic is prepared by attaching a smallchemical to the patient's tumor cells in a process known ashaptenization. This hapten modification allows the tumor cells tostimulate a T cell-based immune response to a patients own tumorcells. An early indicator of T cell immune activity is DTH. Apreviously published article in the Journal of Clinical Oncology,February 2004 reported actual five-year survival data for a group of214 patients with clinically evident Stage III melanoma treated withthe AC Vaccine following surgery. The study demonstrated five-yearsurvival of 45% and showed a highly statistically significantrelationship 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 clinicaleffectiveness of current and future product candidates. Previouslyclinical trials in ovarian and renal cell carcinoma, demonstratedstrong DTH responses consistent with those reported for melanomapatients.
Information for Physicians in Switzerland
Investigators interested in learning more about the vaccine shouldcontact Mrs. Sonja Wehrli at + 41 -41 769 1000. At the present timeinformation about the commercial marketing of the vaccine is onlyavailable to healthcare professionals.
Except for statements that are historical, the statements in thisrelease are "forward-looking" statements that are made pursuant to thesafe harbor provisions of Section 27A of the Securities Act of 1933and Section 21E of the Securities Exchange Act of 1934.Forward-looking statements involve significant risks anduncertainties, and in light of the significant uncertainties inherentin such statements, the inclusion of such information should not beregarded as a representation by AVAX that the objectives and plans ofthe Company will be achieved. In fact, actual results could differmaterially 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 vaccinetechnologies, (2) possible future FDA or AFSSAPS questions regardingthe Company's products and manufacturing processes, (3) the Company'sneed for additional capital in the future to continue its developmentprograms, (4) the Company's ability to maintain its rights underlicense agreements and to meet funding requirements under its licenseagreements, (5) the Company's ability to demonstrate the safety andefficacy of product candidates at each stage of development and tomeet applicable regulatory standards and receive required regulatoryapprovals, (6) the Company's ability to manufacture, receive and shipits vaccine products for clinical and commercial distribution, as wellas other risks detailed from time to time in AVAX's public disclosurefilings with the Securities and Exchange Commission, including itsAnnual Report on Form 10-KSB for the year ended December 31, 2004.AVAX does not undertake any obligation to release publicly anyrevisions to these forward-looking statements or to reflect theoccurrence of unanticipated events.
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