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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
June 10, 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 5 Pages
Exhibit Index Appears at Page 3
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Item 5. Other Events
AVAX Technologies, Inc. (the "Company"), announced on Wednesday,
June 10, 1998 that a new dosing regimen increases the immunological response to
its melanoma vaccine as a post-surgical treatment in Stage 3 melanoma patients.
The study, comprising 61 patients, confirms and expands upon earlier findings of
two other Phase II trials which were published last year in the Journal of
Clinical Oncology.
Reference is made to the Company's related press release attached
hereto as Exhibit 99.12 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) Exhibits:
99.12 Press Release dated June 10, 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: June 10, 1998
By: /s/ Jeffrey M. Jonas
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Name: Jeffrey M. Jonas, M.D.
Title: President and Chief Executive
Officer
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Exhibit Index
Exhibit Number Description
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99.12 Press Release dated June 10, 1998.
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EXHIBIT 99.12
Contact Jeffery M. Jonas, MD Thomas Redington
Chief Executive Officer 203/222-7399
816/960-1333 212/926-1733
New Test With AVAX Cancer Vaccine
Shows Significantly Better Response
KANSAS CITY, MO. JUNE 10 -- AVAX Technologies, Inc. (Nasdaq: AVXT) said a
new dosing regimen significantly increased the immunological response to its
melanoma vaccine as a post-surgical treatment in Stage 3 melanoma patients.
The immune response was measured in an ongoing Phase II clinical trial by
a delayed-type hypersensitivity (DTH) skin reaction, a test similar to the
widely used skin test for tuberculosis.
After six weeks of therapy with M-Vax(TM), an autologous haptenized whole
cell vaccine, a positive DTH reaction to their own tumor cells developed in
two-thirds of the patients enrolled in the study.
The percentage of responding patients was significantly higher than that
found in earlier studies using other dosing regimens. Analysis of results to
date indicate that the 18-month survival rate is almost 80 percent, consistent
with findings from earlier studies where overall clinical outcome at 5 years was
very favorable.
The study, comprising 61 patients, confirms and expands upon earlier
findings of two other Phase II trials which were published last year in the
Journal of Clinical Oncology.
Those studies showed that a positive DTH response to patients' own tumor
cells was strongly associated with clinical benefit. The studies yielded an
overall 5-year survival of almost 60 percent in patients with clinical Stage 3
melanoma, which compares to the 20-25 percent survival in published control
subjects who received no post-surgical therapy.
In commenting on the new findings, Jeffrey M. Jonas, MD, president and CEO
of AVAX, was gratified that "these exciting results confirm the findings from
earlier studies." Jonas noted that "the results provide an even stronger basis
for our optimism going into the pivotal Phase III study, since it will use an
identical dosing regimen."
The M-VAX studies are being conducted by David Berd, MD, chairman of the
Scientific Advisory Board of AVAX, which holds the worldwide license to the
technology. Dr. Berd is the inventor of the AC-Vaccine(TM) technology and also
serves as Professor of Medicine at Thomas Jefferson University's Kimmel Cancer
Center in Philadelphia, Pennsylvania.
AVAX Technologies, Inc. is a development-stage biopharmaceutical company
that acquires rights to and is developing technologies and products for the
treatment of cancer and other life-
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threatening diseases. The company has focused its initial clinical efforts
primarily on the development of immunotherapies and chemotherapies for cancer.
Immunotherapy is a rapidly developing segment of the therapeutic market.
# # #
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
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 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 March 31, 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.
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