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AVAX Technologies Announces Clearance to Commence Clinical Trials for Its Autologous Cell Vaccine M-Vax in United States.


PHILADELPHIA -- Multi-Center Trials to Be Sourced from the Company's Manufacturing Facility in Lyon, France

AVAX Technologies, Inc. (OTCMarket:AVXT.OB) today announces that it has received acknowledgement from the Food and Drug Administration (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.
) that it may begin a clinical trial of its autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism.

au·tol·o·gous
adj.
1.
, hapten-modified melanoma vaccine, M-Vax 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. . The Company submitted an amendment to its previously approved IND filed in November 2002. In addition to adding a control arm the study, the IND amendment included changing the source of the manufacturing of the vaccine to the companies manufacturing facility in Lyon, France.

The study, which will be the first clinical trial of M-Vax since the re-engineering of the manufacturing process to make the vaccine, is expected to enroll patients in the beginning of 2005. A maximum of 56 patients with stage III or IV melanoma will be assigned in a double-blind design to one of four vaccine dosage groups, including one group receiving a zero-cell dose. Patients will be evaluated for safety and for the development of an 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 autologous melanoma cells, as measured by 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. ). The trial will determine whether M-Vax is bio-equivalent to the original autologous, hapten-modified vaccine. Administration of the original vaccine to 214 patients with clinically evident stage III melanoma after lymphadenectomy resulted in a five-year over survival of 45%. Moreover, patients who developed DTH to autologous, unmodified melanoma cells had an overall survival rate that was double that of patients who did not (59.3% vs. 29.3%, p less than .001); these results were published 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.  in February, 2004 and commented upon in an editorial commissioned by the Journal.

"We are happy to be able to re-initiate clinical programs with the AC Vaccine technology" stated Dr. David Berd, Chief Medical Officer and inventor of the vaccine technology. "In addition to the re-establishment of the melanoma program we are quite optimistic about identifying additional potential human cancers for treatment with the vaccine as was previously demonstrated with ovarian and renal cell cancers."

Richard Rainey, President of AVAX stated "We are quite excited about this opportunity to re-launch our clinical program. It is important that we will be using DTH responsiveness as a surrogate clinical endpoint to measure the biological activity of M-Vax. We believe the data supporting the relevance of DTH is quite compelling and that this marker will continue to be of value in later stage clinical trials. Most importantly, this is the first step in AVAX's regulatory plan for M-Vax building to the re-initiation of US pivotal registration trials."

European Regulatory Strategy

AVAX is pursuing the filing of a BLA BLA
abbr.
Bachelor of Liberal Arts
 with the French authorities for the treatment of melanoma patients. As part of the registration process the Company's facility in Lyon was inspected by AFSAPPS and deemed to be in compliance for the production of M-Vax in accordance with cGMP manufacturing requirements for cell and gene therapies. The second aspect of the filing will include efficacy claims to be made for the vaccine which is currently being prepared to be filed. In addition the Company continues to treat patients on a compassionate use compassionate use Pharmacology The use of an agent to treat Pts for whom conventional therapies have failed, or for whom no other drug exists; CU refers to the use of an agent on humanitarian grounds before it has received regulatory–FDA–approval  basis in conjunction with its European distribution partner Grupo Ferrar SA.

About the AC Vaccine Therapeutic

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. In addition the Company offers contract-manufacturing services of biological products to other pharmaceutical and biotechnology companies.

AVAX's AC Vaccine is a therapeutic treatment for cancer. Recently published data for a group of 214 patients with Stage III melanoma showed 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.  of 45% and a statistically significant relationship between survival and a 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, DTH (Journal of Clinical Oncology, February, 2004). In addition, administration of the vaccine to patients with Stage IV melanoma caused objective regression of tumors in some patients, particularly those with lung metastases lung metastases Oncology Cancer that has spread from the original–primary tumor to the lung; primary lung cancer spreads to the brain, bone, BM, liver. See Metastasis. . In earlier reported 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.
, administration of the vaccine induced DTH responses similar to those observed in melanoma patients, indicating that this approach is applicable to other human cancers.

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 programs, (2) the results of laboratory testing of its vaccine technologies, (3) possible future FDA or AFSSAPS AFSSAPS Agence Francaise de Securite Sanitaire des Produits de Sante  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 on November 8, 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.
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:Dec 16, 2004
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