SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
---------------------------
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
December 14, 1998
Date of Report (Date of earliest event reported)
AVAX TECHNOLOGIES, INC.
(Exact name of Registrant as specified in its charter)
Delaware 000-29222 13-3575874
(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification Number)
4520 Main Street
Suite 930
Kansas City, MO 64111
(Address of principal executive offices)
(816) 960-1333
(Registrant's telephone number, including area code)
Page 1 of 4 Pages
Exhibit Index Appears at Page 3
<PAGE>
Item 5. Other Events
AVAX Technologies, Inc. (the "Company"), announced on Monday,
December 14, 1998 that it had presented an initial talk at a National Cancer
Institute-FDA sponsored workshop on the regulation of new cancer vaccines on
December 11, 1998, on the campus of the National Institutes of Health in
Bethesda, Maryland.
Reference is made to the Company's related press release attached
hereto as Exhibit 99.22 and incorporated by reference herein (including, without
limitation, the information set forth in the cautionary statement contained in
the final paragraph of the press release).
Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits
(c) Exhibit:
99.22 Press Release dated December 14, 1998.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
AVAX TECHNOLOGIES, INC.
Date: December 15, 1998
By: /s/ Jeffrey M. Jonas
---------------------------------------------
Name: Jeffrey M. Jonas, M.D.
Title: President and Chief Executive Officer
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<PAGE>
Exhibit Index
Exhibit Number Description
- -------------- -----------
99.22 Press Release dated December 14, 1998.
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EXHIBIT 99.22
AVAX Technologies, Inc.
4520 Main Street
Suite 930
Kansas City, MO 64111
Contact: Erika Rich
(816) 960-1333
[email protected]
FOR IMMEDIATE RELEASE
December 14, 1998
AVAX TECHNOLOGIES PRESENTS DATA AT JOINT
FDA-NCI WORKSHOP
(Kansas City, MO)- AVAX Technologies, Inc. (NASDAQ:AVXT) a
biopharmaceutical company focusing on cancer vaccine development, announced
today that at the invitation of the Food and Drug Administration (FDA) it had
presented an initial talk at a National Cancer Institute-FDA sponsored workshop
on the regulation of new cancer vaccines on December 11, 1998, on the campus of
the National Institutes of Health in Bethesda, Maryland.
The FDA is actively working to develop a regulatory framework that will
ensure the safety and efficacy of these vaccines, and has therefore turned to
members of academia and industry for advice. AVAX presented data obtained in its
development program pertaining to the manufacture and characterization of its
vaccine technology.
AVAX Technologies is an innovative and growth-oriented biopharmaceutical
company specializing in the development and commercialization of novel
technologies for the treatment of cancer and other life threatening diseases.
Currently, the company is focusing its efforts on the development of
immunotherapies and chemotherapies for cancer, including a tumor vaccine for
stage 3 melanoma, M-Vax(TM). The vaccine, which utilizes the patient's cancer
cells, attempts to stimulate the patient's immune system and eliminate the
cancer. Pivotal registration clinical trials as post-surgical therapy in Stage 3
melanoma are currently underway.
Dr. Jeffrey M. Jonas, president and chief executive officer of AVAX and
former chief medical officer of Upjohn Company, commented, "We were pleased to
have this opportunity to present AVAX's thoughts and progress in the area. We
are hopeful that this workshop will lead to decisions that may expedite the
development of cancer vaccines that AVAX and other companies are developing."
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 the Private Securities Litigation Reform Act of 1995 and Section
29A 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 ability to achieve the
stated outcomes and to successfully develop and commercialize its product
candidates, including, among other things, the ability to obtain substantial
additional funds, obtain and maintain all necessary patents or licenses, to
demonstrate the safety and efficacy of product candidates at each state of
development, to meet applicable regulatory standards and receive required
regulatory approvals, to meet obligations and required milestones under its
license agreements, to be capable of producing drug candidates in commercial
quantities at reasonable costs, to compete successfully against other products,
and to market products in a profitable manner, as well as other risks detailed
from time to time in AVAX's public disclosure filings with the Securities and
Exchange Commission, including, without limitation, its Annual Report on Form
10-KSB for the fiscal year ended December 31, 1997 and its Quarterly Report on
Form 10-QSB for the Period Ended September 30, 1998. AVAX does not undertake any
obligation to publicly release any revisions to these forward-looking statements
or to reflect the occurrence of unanticipated events.
12/14/98
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