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
October 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 5 Pages
Exhibit Index Appears at Page 3
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Item 5. Other Events
AVAX Technologies, Inc. (the "Company") announced on Tuesday,
October 27, 1998 that it has initiated its 15th U.S. clinical site for its
pivotal registration trial of M-Vax(TM), an experimental autologous vaccine for
treating Stage 3 melanoma. The Company's randomized, multi-center registration
trial is designed to compare the efficacy of M-Vax against that of high dose
alpha interferon.
Reference is made to the Company's related press release attached
hereto as Exhibit 99.21 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:
99.21 Press Release dated October 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: October 28, 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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99.21 Press Release dated October 27, 1998.
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EXHIBIT 99.21
Contact Jeffrey M. Jonas, MD Thomas Redington
Chief Executive Officer 203/222-7399
816/960-1333 212/926-1733
AVAX Pivotal Cancer Vaccine Trial Well Underway; Registration Study to Include
400 Patients at up to 25 Sites
KANSAS CITY, Mo., Oct. 27 -- AVAX Technologies, Inc. (Nasdaq: AVXT) said it has
initiated its 15th U.S. clinical site for its pivotal registration trial of
M-Vax(TM), an experimental autologous vaccine for treating Stage 3 melanoma. The
company expects to enroll over 400 patients, at up to 25 sites.
The sites activated thus far include the University of Illinois Medical Center,
University of Pennsylvania Cancer Center, Sidney Kimmel Cancer Center in San
Diego, H. Lee Moffitt Cancer Center in Tampa, Cleveland Clinic Foundation Cancer
Center, and Kimmel Cancer Center in Philadelphia.
Enrollment is continuing into this randomized, multi-center registration trial
which is designed to compare the efficacy of M-Vax against that of high dose
alpha interferon.
The pivotal study's two endpoints are: (1) time to recurrence of tumor; and (2)
patient survival. The dosing regimen will be identical to that used in a Phase
II study that showed two-thirds of patients undergoing 6-weeks of therapy with
M-Vax developed an immune response against their own tumor cells.
Results of earlier Phase II studies of M-Vax conducted under an investigator IND
by David Berd, MD, 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, 8 out of 9 Stage 3 ovarian cancer patients had a positive reaction to
their own ovarian cancer cells. 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 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, MD, president and
chief executive officer of AVAX said: "We are pleased to have achieved this
second M-Vax milestone so rapidly: first, the FDA's decision to activate our
corporate IND, and second, the initiation of 15 U.S. clinical sites. We look
forward to bringing additional sites on board as well as continued enrollment."
AVAX said its vaccine technology works by "training" the patient's immune system
to attack cancer cells via natural processes, with low toxicity. The vaccine is
made by treating the patient's
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own cancer cells with hapten molecules (which provide a marker for the immune
system to recognize) 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 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 June 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
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