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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 29, 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 Monday, June
29, 1998 that the Gynecologic Oncology Group, funded by the National Cancer
Institute, has voted to conduct a Phase I/II clinical study of the O-Vax(TM)
vaccine in Stage 3 ovarian cancer patients. O-Vax is the second member of a
family of cancer vaccines under development by AVAX to undergo larger scale
clinical testing in patients.
Reference is made to the Company's related press release attached
hereto as Exhibit 99.15 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:
99.15 Press Release dated June 29, 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 29, 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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99.15 Press Release dated June 29, 1998.
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EXHIBIT 99.15
Contact Jeffery M. Jonas, MD Thomas Redington
Chief Executive Officer 203/222-7399
816/960-1333 212/926-1733
NCI To Fund Ovarian Cancer Trial
With Novel AVAX Immunotherapy
KANSAS CITY, MO JUNE 29 - AVAX Technologies, Inc. (Nasdaq: AVXT) announced
today that the Gynecologic Oncology Group (GOG), funded by the National Cancer
Institute, has voted to conduct a Phase I/II clinical study of the O-Vax(TM)
vaccine in Stage 3 ovarian cancer patients. O-Vax is the second member of a
family of cancer tumor vaccines under development by AVAX to undergo larger
scale clinical testing in patients.
The company said this new clinical trial will be a follow-up to a smaller
study already underway by David Berd, MD, Professor of Medicine, Thomas
Jefferson University. In the ongoing study, the vaccine is administered to
patients who have had surgical debulking and one round of conventional
chemotherapy.
Early results from the current study have been very encouraging. The
vaccine has produced promising immune responses against the patients' own tumor
cells, as measured by a delayed-type hypersensitivity (DTH) reaction, the
primary endpoint of the study. The new GOG-sponsored study will also use DTH as
a primary endpoint but will involve a larger number of patients.
Supplies of O-Vax, an autologous, haptenized tumor cell suspension based
on the company's AC Vaccine technology, will be manufactured centrally in a
certified clean room facility constructed by AVAX at Thomas Jefferson
University.
Jeffrey M. Jonas, MD, president and chief executive officer of AVAX
Technologies, said, "We are very pleased by the action taken by the NCI and GOG
and look forward to working with them. We view the GOG's interest in O-Vax as
further encouragement for development of this product for prevention of
recurrence of ovarian cancer, recognizing there are few available alternatives
for these patients."
O-Vax is the second AC Vaccine product under development by AVAX to show
positive clinical results. The first is M-Vax(TM), a vaccine for melanoma which
has been studied as a post-surgical adjuvant in clinical Stage 3 melanoma
patients. Results from the Phase I/II studies have been reported to show a
five-year overall patient survival rate of almost 60 percent, nearly a
three-fold increase compared to rates in patients treated with surgery only.
In addition to AC Vaccines for melanoma, ovarian and other cancers, the
company currently has under research and development two series of patented
compounds - topoisomerase inhibitors and novel anti-estrogens -
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which belong to classes of chemotherapeutic agents with clinically proven
anti-cancer capabilities.
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
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 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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