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
April 21, 1999 (April 5, 1999)
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
The sole purpose of this Form 8-K is to file a press release issued by
AVAX Technologies, Inc. on April 5, 1999 announcing that its investigational
proprietary Autologous Cell (AC Vaccine(TM)) vaccine for the treatment of Stage
3 melanoma, known as M-Vax(TM), received Orphan Drug designation from the U.S.
Food and Drug Administration.
Item 7. Financial Statements and Exhibits.
Exhibits: 99.4 Press Release dated April 5, 1999.
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: April 19, 1999
By: /s/ Jeffrey M. Jonas
------------------------
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 April 5, 1999.
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EXHIBIT 99.4
Monday April 5, 1999, 6:32am
Company Press Release
AVAX TECHNOLOGIES RECEIVES ORPHAN DRUG STATUS
FOR ITS M-VAX(TM) CANCER VACCINE
KANSAS CITY, MISSOURI, -- April 5, 1999 - AVAX TECHNOLOGIES, INC. ("AVAX")
(Nasdaq: AVXT) today announced that its investigational proprietary Autologous
Cell (AC(TM)) vaccine for the treatment of Stage 3 melanoma, known as M-Vax(TM),
received Orphan Drug designation from the U.S. Food and Drug Administration.
Orphan drug designation entitles AVAX to exclusive marketing rights in the
United States on the vaccine for seven years following marketing approval, and
enables the company to obtain research funding, tax credits for certain research
expenses, and a waiver from the application user fee.
"As we work toward FDA approval of our therapeutic cancer vaccine, M-Vax, Orphan
Drug status represents a significant milestone for the company," said Jeffrey M.
Jonas, M.D., president and chief executive officer of AVAX Technologies, Inc.
"This important designation protects our financial interests and provides us
with additional support from the FDA Orphan Drug Office in our efforts to
develop and register this innovative product."
"To date, over 300 patients have been treated with the M-Vax vaccine under an
investigational new drug application. Data from these studies indicate that the
vaccine has improved survival outcomes in patients with stage 3 melanoma,
increasing 5-year survival rates to 55%, compared with historical control rates
of 22% in patients treated with post-surgical therapy alone. We look forward to
confirming the clinical promise of this unique investigational cancer therapy
and are currently conducting patient enrollment for a pivotal registration trial
of M-Vax at 25-30 clinical sites throughout the United States."
The Orphan Drug Act was adopted in 1982, and provides financial incentives to
stimulate the development of drugs for rare diseases affecting 200,000 people or
less in the United States. More than one company may receive orphan drug
designation while a drug is under development, but the first company to obtain
approval for a designated drug receives US marketing exclusivity for seven years
for the approved indication. Melanoma is the most serious form of skin cancer
and afflicts approximately 390,000 people worldwide. The American Cancer Society
estimates that approximately 41,600 new cases are diagnosed each year in the
U.S. Although melanoma only accounts for five percent of all skin cancers, the
disease is responsible for over 75 percent of skin-cancer related deaths.
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AVAX Technologies, Inc. specializes in the development and commercialization of
novel biotechnologies, immunotherapies and pharmaceuticals for cancer and other
life-threatening diseases using three core technologies: autologous cell (AC)
vaccines, topoisomerase inhibitors and anti-estrogens.
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 filings with the Securities and Exchange
Commission, including, without limitation, its Annual Report on Form 10-KSB for
the fiscal year ended December 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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