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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
January 28, 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)
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Item 5. Other Events
AVAX Technologies, Inc. ("the Company") has announced that it is
supplying the United States Food and Drug Administration ("FDA") with
information to further characterize the Company's initial AC Vaccine(TM),
M-Vax(TM) in response to a request by the FDA. To ensure that all pivotal study
data will fully support a product license application, no patients will be
enrolled in registration clinical trials until the Company and FDA are satisfied
that all product characterization issues are fully resolved. The Company will
continue all other aspects of its development plan for such trials, and believes
that its original estimates of time for completion of clinical trials and for a
product license application are not affected.
Reference is made to the Company's related press release attached
hereto as Exhibit 99.4 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:
99.4 Press Release dated January 28, 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: January 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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99.4 Press Release dated January 28, 1998.
EXHIBIT 99.4
Contact Jeffery M. Jonas, MD Thomas Redington
Chief Executive Officer 203/222-7399
816/960-1333 212/926-1733
AVAX ACCELERATING PRODUCT DATA TO FDA
KANSAS CITY, MO JAN. 28 -- AVAX Technologies, Inc. (Nasdaq: AVXT) is
supplying the US FDA with information to further characterize its experimental
autologous M-VAX(TM) vaccine for treating Stage 3 melanoma, in response to a
request by the FDA.
The company said it is holding off plans to start enrollment in a
pivotal multi-center trial of the vaccine until it and the FDA are satisfied
that all product specifications are fully characterized.
The company will continue all other aspects of its development plan
for the pivotal clinical trial, and believes its original estimates of time for
completion of the trials and for a product license application are not affected.
Providing the requested information affords the company an
opportunity to work more closely with the FDA, and may enhance the agency's
review of the company's development program for its immunotherapeutic vaccines.
It could also enhance the FDA's ability to determine if the company's products
ultimately satisfy regulatory and statutory criteria necessary for marketing
approval.
Results of a Phase II study of the vaccine showed a three-fold
increase in five-year survival rates of patients treated with M-VAX vs. surgery
alone.
M-Vax is one of several therapeutic vaccines for cancer based on the
core AC Vaccine technology under development by AVAX Technologies. In addition
to AC Vaccines for ovarian and other cancers, 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.
AVAX Technologies is a development-stage biopharmaceutical company
which 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.
Statements in this news release that are not strictly historical,
including statements as to plans and objectives, are "forward-looking"
statements that are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Although AVAX Technologies believes
that the expectations reflected in such forward-looking statements are
reasonable, it can give no assurance that the expectations will prove to be
correct. Factors that could cause actual results to differ materially from AVAX
Technologies' expectations include, among others, the company's dependence on
licenses and sponsored research agreements; the ability of the company and
others to clinically develop, manufacture and market
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the company's pharmaceutical products; government regulation and approval by the
FDA of the company's products for sale in the US; the company's ability to
obtain additional financing needed for manufacturing, marketing and distribution
of the company's products; the company's access to and the market's acceptance
of new products; a limited public market for the company's stock; possibly price
volatility and illiquidity of the company's stock; as well as the risks,
uncertainties, and other factors described in the company's prospectus and other
documents on file with the Securities and Exchange Commission. The company 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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