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 13, 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 13, 1999 announcing new results in its
continuing testing and evaluation of the Company's AC Vaccine(TM) for the
treatment of patients with Melanoma, M-Vax(TM).
Item 7. Financial Statements and Exhibits.
Exhibits: 99.5 Press Release dated April 13, 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
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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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99.5 Press Release dated April 13, 1999.
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Tuesday April 13, 1999, 1:15pm
Company Press Release
*** NOT REVIEWED BY THE AMERICAN ASSOCIATION FOR
CANCER RESEARCH
MELANOMA VACCINE M-VAX(TM) SHOWS PROMISE IN THE MOST ADVANCED
CASES OF STAGE III MELANOMA
--- Study Supports Clinical Utility of Vaccine Therapy
in the Treatment of Cancer --
PHILADELPHIA, PA, APRIL 13, 1999 - Post-surgical treatment with the autologous
cell vaccine (AC Vaccine(TM)), M-Vax(TM), appears to extend survival and reduce
relapse rates in melanoma patients whose disease had metastasized to two nodal
sites, according to the results of a Phase 2 clinical trial. The findings of the
study, which was sponsored by AVAX Technologies, Inc. (AVAX), were presented
today at the 90th annual meeting of the American Association for Cancer Research
(AACR), and suggest that vaccines may play an important role in the treatment of
one of the most fatal forms of cancer.
M-Vax(TM) is one of AVAX's AC Vaccines(TM) that is made from the patient's
own cancer cells. The vaccine is made by modifying the tumor cells with a
molecule called a "hapten." This process, known as "haptenization," alters the
tumor cells and makes them appear foreign to the patient's immune system. When
the hapten-modified cells are injected into patients, they stimulate the immune
system to recognize the cancer cells and destroy them.
"These data support and expand on the results of previous Phase 2 trials,
which suggested that M-Vax(TM) increased the overall survival rate in patients
with large, surgically resectable metastases to a single lymph node site," said
David Berd, MD, principal trial investigator, inventor of the AC Vaccine(TM) and
professor of medicine, Kimmel Cancer Center, Thomas Jefferson University,
Philadelphia, PA. "Now, we have extended those findings to patients with a much
lower chance of cure with surgery alone. All of the patients in the current
study had recurrence of their melanoma in a second lymph node before receiving
M-Vax(TM)."
Out of the 40 patients who participated in the trial, 43 percent (n=17)
are still alive and 30 percent (n=12) have remained relapse free. Currently, the
expected five-year survival rate after surgery alone is less than ten percent. A
subgroup of 15 patients with a particularly bad prognosis - i.e., those with an
extensive spread of melanoma to the pelvic lymph nodes - did surprisingly well
after treatment with M-Vax(TM). A five-year survival rate of 47 percent is
projected for this subgroup, compared to a five-to-ten percent historical
survival rate with surgery alone.
"AVAX is very encouraged by the compelling data presented by Dr. Berd
which indicates that M-Vax(TM) may help patients who have a low chance of
survival with surgery alone," said Jeffrey M. Jonas, M.D., President and Chief
Executive Officer of AVAX Technologies, Inc. "We believe the data continue to
provide evidence of the clinical utility of AVAX's AC Vaccine(TM) technology,
and bode well for the outcome of our ongoing pivotal
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registration trial for M-Vax in patients with stage III melanoma. These data
further encourage us to evaluate the effectiveness of the AC Vaccine(TM) not
only in melanoma and ovarian cancer (O-Vax(TM)), but in other cancers as well."
In this study, patients were treated with multiple injections of M-Vax(TM)
using one of four dosage schedules over a two-to-six month period. No serious
adverse events occurred. All patients developed inflammatory or pustular
reactions at the vaccine injection sites, which caused itching or mild
discomfort.
Melanoma is the most serious form of skin cancer and affects approximately
390,000 people worldwide. The American Cancer Society estimates that in the US
alone, over 40,000 new cases are diagnosed and over 7,000 people die from the
disease every year. The current treatment for stage III melanoma is surgical
removal of the tumor mass, followed by high doses of alpha-interferon, a form of
chemotherapy. AVAX is currently conducting a multi-center pivotal registration
clinical trials comparing M-Vax(TM) with alpha-interferon in post-surgical stage
III melanoma patients.
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:
the AC Vaccine (TM) technology, 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
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 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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