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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
August 24, 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. announced on Monday, August 24, 1998, the
completion of a pilot Phase I/II immunological clinical study of O-Vax(TM), its
experimental vaccine of haptenized autologous ovarian cancer cells. The results
showed that 8 of 9 patients with stage 3 ovarian cancer who received O-Vax
post-surgically after standard chemotherapy, developed an immune response
against their own tumor cells.
The study found that chemotherapy prevented none of the patients
from developing a strong, positive immune response to their own haptenized
ovarian cancer cells, as measured by tests for delayed-type hypersensitivity.
Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits
(c) Exhibits:
99.19 Press Release dated August 24, 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: August 24, 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
- -------------- -----------
99.19 Press Release dated August 24, 1998.
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EXHIBIT 99.19
Contact Jeffrey M. Jonas, MD Thomas Redington
Chief Executive Officer 203/222-7399
816/960-1333 212/926-1733
AVAX COMPLETES PILOT STUDY OF OVARIAN CANCER TREATMENT
Data Considered Promising Demonstration
Of Therapeutic Principle
KANSAS CITY, MO AUG. 24 - AVAX Technologies, Inc. (Nasdaq: AVXT) completed
a pilot Phase I/II immunological study of O-Vax(TM), its experimental vaccine of
haptenized autologous ovarian cancer cells.
The results showed that eight of nine patients with Stage 3 ovarian cancer
who received O-Vax post-surgically after standard chemotherapy developed an
immune response against their own tumor cells.
Stage 3 ovarian cancer is characterized by abdominal metastases. After
surgical debulking of the metastases and six cycles of standard chemotherapy
(taxol plus either cisplatin or carboplatin), the patients received six weekly
doses of O-Vax.
All patients were tested for delayed-type hypersensitivity (DTH), a
measure of the activity of T lymphocytes, both before treatment and again 2 1/2
weeks after the last vaccine dose.
Chemotherapy Didn't Interfere
The study found that the chemotherapy didn't prevent any of the patients
from developing a strong, positive immune response to their own haptenized
ovarian cancer cells, as measured by DTH.
Eight out of the nine patients also responded to their own unmodified
ovarian cancer cells.
In earlier studies of patients with melanoma, it was found that this type
of immune response predicted a favorable clinical response to treatment with
vaccine therapy. These data are considered a promising proof-of-principle
demonstration of the potential of O-Vax treatment in ovarian cancer.
AVAX initiated the O-Vax trials following results from patients with Stage
3 melanoma who had been treated with M-Vax(TM), the company's initial AC Vaccine
for the treatment of melanoma.
The M-Vax study was conducted by David Berd, MD, professor of medicine at
Thomas Jefferson University's (TJU) Kimmel Cancer Center. Dr. Berd is the
inventor of the company's in-licensed autologous cell vaccine technology (AC
Vaccine(TM)) and the chairman of the Scientific Advisory Board of AVAX
Technologies, Inc.
As previously reported, M-Vax is believed by AVAX to be the first
therapeutic cancer vaccine to show a substantial increase in the survival rate
for patients with Stage 3 melanoma.
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AVAX is preparing to conduct a large, multicenter trial with O-Vax in
post-surgical Stage 3 ovarian cancer patients, using essentially the same
regimen as was used in the pilot study. To aid in developing the final protocol
and in conducting the trial, the company is now organizing a panel of ovarian
cancer experts from specialized cancer centers throughout the US.
Jeffrey M. Jonas, MD, president and chief executive officer of AVAX, said,
"The results from this completed pilot study of ovarian cancer patients show
that the DTH response was at least as great as that observed earlier in our
melanoma trials, and both confirm and expand on the findings we announced
earlier before the study was completed. We believe these results provide a solid
basis for conducting a larger clinical efficacy trial with O-Vax in ovarian
cancer aimed at registration that is already in an advanced stage of
preparation."
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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