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AVAX Technologies Completes First Step in Registering Its Lead Product, M-Vax, for Commercial Marketing and Distribution in France.


PHILADELPHIA -- AVAX Technologies, Inc. (OTCMarket:AVXT.OB) today announces that its wholly owned French subsidiary has been notified by AFSSAPS AFSSAPS Agence Francaise de Securite Sanitaire des Produits de Sante , the French regulatory authorities, that AVAX's facility in Lyon, France has received authorization for the production and distribution of AVAX's lead product M-Vax, the AC Vaccine therapeutic for the treatment of patients with melanoma. Under recently enacted regulations by AFSSAPS for individualized in·di·vid·u·al·ize  
tr.v. in·di·vid·u·al·ized, in·di·vid·u·al·iz·ing, in·di·vid·u·al·iz·es
1. To give individuality to.

2. To consider or treat individually; particularize.

3.
 pharmaceutical products, the designation of a facility by AFSSAPS is the first step required for ultimate regulatory approval of an individualized product for distribution in France.

Under French regulations, a company is required to file with AFSSAPS two separate dossiers for cell or gene therapies. The first requires the company to demonstrate its ability to produce its products under current Good Manufacturing Practices (cGMP) conditions, while the second dossier requires the demonstration of the clinical effectiveness of the treatment.

AVAX has been notified by AFSSAPS that the AVAX dossier previously filed for the cGMP certification of the Lyon facility for the production of M-Vax has been approved by AFSSAPS, and the Lyon facility is now certified as cGMP compliant under the new French regulations for individualized cell and gene therapies.

The President of AVAX, Richard P. Rainey stated, "We are delighted to have achieved this designation, which is the result of a significant effort by our manufacturing team in Lyon, France. This designation satisfies the Company's requirements to demonstrate its ability to manufacture M-Vax in accordance with cGMP. Now that we have executed on the first requirements for obtaining regulatory authorization for M-Vax in France, our team is now in the process of finalizing the second dossier, which details the clinical effectiveness of M-Vax".

In addition to its commercialization program for M-Vax, AVAX is continuing to work to define the broad-based utility of its AC Vaccine Therapeutic in a range of solid tumors. The Company intends to source world-wide clinical and commercial programs for the AC Vaccine through its facility in Lyon, France.

About AVAX's AC Vaccine

AVAX's AC Vaccine platform is a therapeutic treatment for cancer. The AC Vaccines are prepared by attaching a small chemical to the patients tumor cells in a process known as haptenization. This hapten hapten /hap·ten/ (hap´ten) partial antigen; a specific nonprotein substance which does not itself elicit antibody formation but does elicit the immune response when coupled with a carrier protein.  modification allows the tumor cells to stimulate a T cell-based immune response immune response
n.
An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes.
 to a patients own tumor cells. An early indicator of T cell immune activity is delayed type hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen.  (DTH (Direct-To-Home) Typically refers to satellite TV broadcasting directly to a dish antenna on the roof of a house. See DBS. ). A recently published article in the Journal of Clinical Oncology The Journal of Clinical Oncology is a medical journal published by the American Society of Clinical Oncology. The Journal was founded in 1983 and publishes original research and review articles on topics relating to cancer. It is published 3 times a month. , February 2004 reported actual five-year survival five-year survival Epidemiology The timespan that a person survives with a particular dread disease, in particular CA; 5YS facilitates standardization of survival statistics. See Cancer-free 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 surrogate marker Lab medicine A parameter or measured to detect a pathologic condition when a more specific test doesn't exist, is impractical or not cost-effective; surrogate testing has been used for non-A, non-B hepatitis, measuring ALT and antibodies to HBV " for survival and an early indicator for clinical effectiveness of current and future product candidates. Previously clinical trials in ovarian and renal cell carcinoma renal cell carcinoma
 or hypernephroma

Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced.
, demonstrated strong DTH responses consistent with those reported for melanoma patients.

AVAX Technologies, Inc. is a biotechnology company with operations in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  and Europe. The Company is engaged in the research, clinical and commercial development of biological products and cancer therapeutics. In addition the Company offers contract-manufacturing services of biological products to other pharmaceutical and biotechnology companies Top 100 Biotechnology Companies
The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies.
.

Except for statements that are historical, the statements in this release are "forward-looking" statements that are made pursuant to the safe harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 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 Company's ability to obtain substantial additional capital to fund its development efforts, (2) the results of testing of its vaccine technologies, (3) possible future FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 or AFSSAPS questions regarding the Company's products and manufacturing processes, (4) the Company's ability to maintain its rights under license and research funding agreements and to meeting funding requirements under its license and research funding 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, 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, 2003 and its Registration Statement on Form SB-2 filed with the SEC. AVAX does not undertake any obligation to release publicly any revisions to these forward-looking statements or to reflect the occurrence of unanticipated events.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Oct 25, 2004
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