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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
May 19, 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 May 19, 1998
that documented evidence of Stage 4 malignant melanoma lung tumor shrinkage
caused solely by a vaccine was presented the day prior at a national meeting of
clinical oncologists. The findings support earlier studies of the vaccine,
conducted in Stage 3 melanoma patients, which showed that it combated the spread
of micro-metastases, the biological seeds of tumor growth.
Reference is made to the Company's related press release attached
hereto as Exhibit 99.10 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:
99.10 Press Release dated May 19, 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: May 19, 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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99.10 Press Release dated May 19, 1998.
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EXHIBIT 99.10
Contact Jeffrey M. Jonas, MD Thomas Redington
Chief Executive Officer 203/222-7399
816/960-1333 212/926-1733
AVAX Cancer Vaccine Shrinks Tumors, Prolongs
Life, In Study Reported At Key US Oncology Meeting
Findings Support Earlier Tests
Showing Halt In Spread Of Deadly Skin Cancer
LOS ANGELES, CA MAY 19 -- AVAX Technologies, Inc. (Nasdaq: AVXT) announced
today that documented evidence of Stage 4 malignant melanoma lung tumor
shrinkage caused solely by a vaccine was presented yesterday at a national
meeting of clinical oncologists.
One of the patients in the study lived nearly three times longer than
similar patients with Stage 4 melanoma, and three others are alive beyond the
current average survival time.
The findings support earlier studies of M-Vax(TM) conducted in Stage 3
melanoma patients that showed the experimental vaccine combated the spread of
micro-metastases, the biological seeds of tumor growth.
Details of the small clinical study were presented here at the 1998 Annual
Meeting of the American Society of Clinical Oncology by the principal
investigator, David Berd, MD, chairman of the Scientific Advisory Board of AVAX
Technologies, Inc., Kansas City, Missouri, which holds the worldwide license to
the technology. Dr. Berd is the inventor of the technology, and also serves as
professor of medicine at Thomas Jefferson University's Kimmel Cancer Center in
Philadelphia, Pennsylvania.
Although several cancer vaccine approaches are under study by others,
AVAX's technology is the first to provide scientific proof of principle that a
vaccine alone - without concurrent use of other drugs - shrinks melanoma tumors
in the lung.
The study provides the first known X-ray evidence of Stage 4 melanoma lung
tumor regression with vaccine administration alone. The treatment does not use
nor rely on chemotherapeutic agents. Jeffrey M. Jonas, MD, president and chief
executive officer of AVAX, stated "These results provide additional support for
our efforts in developing M-Vax, which we believe is the first practical hope
for a vaccine that would be capable of halting the spread of metastatic
melanoma, the deadly skin cancer, without the toxicity associated with
chemotherapy."
Dr. Berd's presentation discussed a treatment for advanced (Stage 4)
melanoma patients whose cancers had metastasized to the lung.
Sixteen evaluable Stage 4 melanoma patients with metastases limited to the
lung were treated with M-Vax, the experimental product. Tumor shrinkage was seen
in four of the 16, with three ranging from 75 to 90 percent shrinkage and a
fourth showing just under 50 percent shrinkage.
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The four patients whose tumors shrank also experienced survival beyond
normal expectations, which is usually considered to be 6-12 months after being
diagnosed with Stage 4 melanoma of this type. Three of the four patients are
still living, having completed treatment between 15 and 24 months ago. The
deceased patient lived 35 months after treatment, or nearly three times longer
than the current average.
An earlier study involved Stage 3 melanoma patients who had been treated
post-surgically with M-Vax. The findings, published in the Journal of Clinical
Oncology (Vol.15, No.6, 6/97), showed that 58 percent of the patients survived
for five years, compared to 22 percent for historical controls.
M-Vax is AVAX's initial autologous cell vaccine ("AC Vaccine") for the
treatment of melanoma. The AC Vaccine is manufactured by a process involving the
removal of a patient's own tumor cells, modifying them with a small molecule
known as a hapten, and reintroducing the product back into the patient. The
approach is based on the premise that a patient's immune response to a strongly
immunogenic, hapten-modified tumor antigen may be followed by the development of
an immune response to the unmodified tumor antigen.
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. The company 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
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
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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 all the company's
subsequent Quarterly Reports on Form 10-QSB. 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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