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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
July 27, 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 6 Pages
Exhibit Index Appears at Page 3
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Item 5. Other Events
AVAX Technologies, Inc. (the "Company"), announced on Monday, July
27, 1998 that the U.S. FDA cleared the way for it to begin a pivotal trial for
registration of M-Vax(TM), an experimental autologous vaccine for treating Stage
3 melanoma. The FDA action follows a review of the Company's Investigational New
Drug (IND) application for M-Vax, which is being studied as post-surgical
adjuvant therapy in Stage 3 melanoma patients.
The Company expects to enroll approximately 400 patients into a
randomized, multi-center trial designed to compare the efficacy of M-Vax against
that of high dose alpha interferon. The pivotal study's two end points are: (1)
rate of melanoma tumor recurrence; and (2) overall survival. The dosing regimen
will be identical to that used in a Phase II study which showed that two-thirds
of patients undergoing 6-weeks of therapy with M-Vax developed an immune
response against their own tumor cells as measured by a skin test (DTH). In
other studies, the ability of M-Vax to produce a positive DTH response was
correlated with overall survival benefit for patients treated with the vaccine.
Results of earlier Phase II studies of M-Vax showed a nearly 60% five-year
survival rate of patients treated with M-Vax.
Reference is made to the Company's related press release attached
hereto as Exhibit 99.18 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:
99.18 Press Release dated July 27, 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: July 27, 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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99.18 Press Release dated July 27, 1998.
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EXHIBIT 99.18
Contact Jeffery M. Jonas, MD Thomas Redington
Chief Executive Officer 203/222-7399
816/960-1333 212/926-1733
US FDA Clears Way For AVAX To Start
Pivotal Trial For Skin Cancer Patients
400-Patient Study Will Compare Efficacy Of
New Vaccine Treatment To Alpha Interferon
KANSAS CITY, MO JULY 27 -- AVAX Technologies, Inc. (Nasdaq: AVXT) said the
US FDA cleared the way for it to begin a pivotal trial for registration of
M-Vax(TM), an experimental autologous vaccine for treating Stage 3 melanoma.
Melanoma is a potentially fatal skin cancer suffered by about 500,000
people worldwide.
The FDA action follows a review of AVAX's company-sponsored
Investigational New Drug (IND) application for M-Vax, which is being studied as
post-surgical adjuvant therapy in Stage 3 melanoma patients.
The company expects to enroll approximately 400 patients into a
randomized, multi-center trial designed to compare the efficacy of M-Vax against
that of high dose alpha interferon.
The pivotal study's two end points are: (1) rate of melanoma tumor
recurrence; and (2) overall survival.
The dosing regimen will be identical to that used in a Phase II study
which showed that two-thirds of patients undergoing 6-weeks of therapy with
M-Vax developed an immune response against their own tumor cells as measured by
a standard skin test called DTH.
In other studies, the ability of M-Vax to produce a positive DTH response
was correlated with overall survival benefit for patients treated with the
vaccine.
Results of earlier Phase II studies of M-Vax conducted under an
investigator IND by David Berd, M.D., Professor of Medicine at Thomas Jefferson
University's Kimmel Cancer Center in Philadelphia, Pennsylvania, showed a nearly
60% five-year survival rate of melanoma patients treated with M-Vax.
AVAX has also applied its vaccine technology to ovarian cancer. In a
recent study, 6 out of 7 ovarian cancer patients had a positive reaction to
their own ovarian cancer cells, as measured by immunological response and the
DTH skin test. The findings led the National Cancer Institute to provide funding
for a Phase I/II trial of O-VAX(TM), the ovarian cancer vaccine.
M-Vax and O-VAX are among several therapeutic vaccines for cancer based on
the core AC Vaccine(TM) technology under development by AVAX Technologies. The
company also currently has under research and development two series of patented
compounds - topoisomerase
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inhibitors and novel anti-estrogens - which belong to classes of
chemotherapeutic agents with clinically proven anti-cancer capabilities.
In commenting on the latest information, Jeffrey M. Jonas, M.D., president
and chief executive officer of AVAX said: "We are very pleased to have
accomplished a major company milestone by FDA allowance of our corporate IND for
M-Vax. We are obviously delighted by FDA's decision to activate this IND, which
we believe will allow us to rapidly move forward with this important clinical
trial.
"This decision is a further step on the path to validate the company's
ability to manufacture the vaccine in a reproducible, commercially attractive
fashion. Equally important, it demonstrates the ability of AVAX's development
team to deal with the regulatory requirements that confront novel therapies."
AVAX said its vaccine technology works by "training" the patient's immune
system to attack cancer cells via natural process, with low toxicity. The
vaccine is made by treating the patient's own cancer cells with hapten molecules
and then injecting the treated cells back into the body.
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-threatening diseases. AVAX has focused its
initial efforts primarily on the development of immunotherapies and
chemotherapies for cancer. Immunotherapy is a rapidly developing segment of the
cancer 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
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
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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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