22.02.2005 15:46:00
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AVAX Technologies Announces Collaboration with the University of Penns
Business Editors/Health/Medical Writers
BIOWIRE2K
PHILADELPHIA--(BUSINESS WIRE)--Feb. 22, 2005--
Research program completed and abstract submitted to AACR
AVAX Technologies, Inc. (OTCMarket:AVXT.OB) today announced that it has established a research collaboration with Dr. Joseph Friedberg, Chief of the Division of Thoracic Surgery at Presbyterian Medical Center, part of the University of Pennsylvania Health System, to conduct a clinical trial of its AC Vaccine in patients with non-small cell lung cancer (NSCLC). Presbyterian Medical Center and Hospital of the University of Pennsylvania, both part of the University of Pennsylvania Health System, will be the exclusive partner and clinical sites for the trial. AVAX and the University plan to submit an Investigational New Drug application (IND) for the treatment of patients with Stage I or II NSCLC to the U.S. Food and Drug Administration by March 31, 2005. The AC Vaccine consists of autologous, lung cancer cells from each patient modified with the hapten, dinitrophenyl (DNP).
The laboratory work leading to the development of the new lung cancer vaccine will be the subject of a presentation to be made at a special conference sponsored by the American Association for Cancer Research, entitled, "Molecular Pathogenesis of Lung Cancer: Opportunities for Translation to the Clinic." The conference will be held in San Diego from February 23-27.
The President of AVAX, Richard P. Rainey stated, "We are quite happy with the successful completion of the laboratory work showing the feasibility of applying the AC Vaccine to the treatment of this highly prevalent and devastating disease. We look forward to the submission of an IND and the initiation of a clinical trial with Dr. Friedberg and his team. Based on the earlier positive clinical results in melanoma patients that had tumors metastasize to the lung, we believe that the potential for the vaccine to benefit patients with primary lung cancer is quite good. We look forward to demonstrating this in our clinical program."
The endpoints of the trial will include safety and a measure of immunological efficacy as measured by Delayed Type Hypersensitivity to patients' own lung cancer cells. Dr. Joseph Friedberg will serve as the Principal Investigator. Previously the Company successfully completed clinical trials in ovarian cancer and renal cell carcinoma using Delayed Type Hypersensitivity endpoints.
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 the AC Vaccine Therapeutic
AVAX's AC Vaccine platform is a therapeutic treatment for cancer. A February 2004 article in the Journal of Clinical Oncology reported actual five-year survival data for a group of 214 patients with Stage III melanoma. The study demonstrated five-year survival of 45% and showed a statistically significant relationship between survival and DTH (delayed type hypersensitivity) response. Notably, based upon these results, DTH appears to be a viable "surrogate marker" for survival but as 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. In addition, in earlier published clinical results on patients with Stage IV melanoma, in one sub-set of patients that had experienced metastases to the lungs there was a 25% response rate in this population of sixteen patients.
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.
Editors note: Dr. Joseph Friedberg has no financial interest in AVAX Technologies, Inc.
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 Company's ability to obtain substantial additional equity to fund its research and development programs, (2) the results of laboratory testing of its AC Vaccine technologies, (3) possible future FDA or AFSSAPS questions regarding the Company's products and manufacturing processes, (4) the Company's ability to maintain its rights under 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, 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. AVAX does not undertake any obligation to release publicly any revisions to these forward-looking statements or to reflect the occurrence of unanticipated events.
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CONTACT: AVAX Technologies, Inc. Richard P. Rainey, 215-241-9760 or University of Pennsylvania Health System Rebecca Harmon, 215-349-5660
KEYWORD: PENNSYLVANIA INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL MEDICAL DEVICES BIOTECHNOLOGY PRODUCT MARKETING AGREEMENTS SOURCE: AVAX Technologies, Inc.
Copyright Business Wire 2005
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