================================================================================
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
March 31, 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
================================================================================
<PAGE>
Item 5. Other Events
AVAX Technologies, Inc. (the "Company") has announced that the
positive immunological results of its experimental vaccine of haptenized
autologous ovarian cancer cells, O-Vax(TM), were presented today by David Berd,
M.D., the Chairman of its Scientific Advisory Board at the 1998 Annual Meeting
of the American Association for Cancer Research in New Orleans, Louisiana.
Reference is made to the Company's related press release attached
hereto as Exhibit 99.7 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:
99.7 Press Release dated March 31, 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: March 31, 1998
By: /s/ Jeffrey M. Jonas
----------------------
Name: Jeffrey M. Jonas, M.D.
Title: President and Chief Executive Officer
<PAGE>
Exhibit Index
Exhibit Number Description
-------------- -----------
99.7 Press Release dated March 31, 1998.
EXHIBIT 99.7
Contact Jeffery M. Jonas, MD Thomas Redington
Chief Executive Officer 203/222-7399
816/960-1333 212/926-1733
Clinical Investigator Reports On Positive Immune Response
To O-Vax(TM) In Stage 3 Ovarian Cancer Patients
Six Of Seven Treated Patients Respond
NEW ORLEANS, LA MAR. 31 - AVAX Technologies, Inc. (Nasdaq: AVXT) announced
that the immunological results of its experimental vaccine of haptenized
autologous ovarian cancer cells, O-Vax(TM), were presented this week by David
Berd, MD, professor of medicine at Thomas Jefferson University's (TJU) Kimmel
Cancer Center, at the 1998 Annual Meting of the American Association for Cancer
Research in New Orleans, LA.
Dr. Berd is the inventor of the company's in-licensed autologous cell
vaccine technology ("AC Vaccine") and the chairman of the Scientific Advisory
Board of AVAX Technologies, Inc.
Dr. Berd's presentation reported on the results to date of the ongoing
Phase I/II clinical trial for O-Vax which is being conducted at TJU. The paper
discussed a treatment for Stage 3 ovarian cancer patients.
After surgical debulking and six cycles of standard chemotherapy (taxol
plus either cisplatin or carboplatin), these patients received six weekly doses
of O-Vax. The 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.
The study showed that six of the seven vaccinated patients developed an
immune response to their own ovarian cancer cells, as measured by DTH.
The study also measured the patients' immune response to their own
haptenized ovarian cancer calls. All developed a strong, positive immune
response, as measured by DTH.
AVAX initiated trials for O-Vax following earlier results obtained 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. 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. The results of the M-Vax trials to date have also shown that a
positive DTH to unmodified tumor cells was predictive of overall survival of
patients with Stage 3 melanoma.
Jeffrey M. Jonas, MD, president and chief executive officer of AVAX, said,
"The results from this recent study of ovarian cancer patients show that the DTH
response was at least as great as that observed earlier in our melanoma trials.
We believe that these results provide a strong rationale for a larger clinical
efficacy trial which 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. 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.
# # #
1
<PAGE>
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 ("PSLRA") 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 from time to time in AVAX's public disclosure filings
with the US Securities and Exchange Commission (SEC), including, without
limitation, its Annual Report on Form 10-KSB for the fiscal year ended December
31, 1997. AVAX does not undertake any obligation to publicly release any
revisions to these forward-looking statements or to reflect the occurrence of
unanticipated events.
2
