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
May 25, 1999 (May 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 May 13, 1999 which discussed clinical trial results
achieved by the Company's O-Vax(TM) product for the treatment of ovarian cancer.
Item 7. Financial Statements and Exhibits.
Exhibits: 99.5 Press Release dated May 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: May 25, 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
- -------------- -----------
99.5 Press Release dated May 13, 1999.
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EXHIBIT 99.5
AVAX TECHNOLOGIES EXTENDS FINDINGS OF EXPERIMENTAL CANCER VACCINE O-VAX(TM)
- New Data Suggest O-Vax Stimulates Immune Response in Patients with Advanced
Ovarian Cancer and May Have Possible Survival Benefits -
KANSAS CITY, MO, May 13, 1999 -AVAX Technologies, Inc. (NASDAQ:AVXT) today
announced additional data from two Phase 1 trials of O-Vax(TM), one of the
company's autologous cell vaccines (AC Vaccine(TM)) for the treatment of stage 3
ovarian cancer. New findings suggest post-surgical treatment with O-Vax appears
to induce immune responses and possibly extends survival in patients with two
forms of advanced ovarian cancer. The data, published in the program of the
upcoming 35th annual meeting of the American Society of Clinical Oncology (May
15-18), highlight the potential of extending AVAX's AC Vaccine technology to
various forms of cancer.
A total of 17 patients were studied in both trials. In the first trial,
nine patients were treated with six weekly intradermal injections of O-Vax after
debulking surgery and standard chemotherapy. Eight out of these nine patients
are alive (median = 25 months) and three are relapse free. Two of these three
relapse-free patients had been suboptimally debulked, usually indicating a less
favorable prognosis. In the second study, using the same vaccine regimen, five
out of eight patients with advanced, bulky disease who had failed chemotherapy
are also alive (median = six months). This study is still ongoing.
"AVAX continues to evaluate the AC Vaccine technology's broad
applicability in other forms of cancer. Previously published data from Phase 2
studies of M-Vax(TM), the company's lead cancer vaccine for Stage 3 melanoma,
showed that post-surgical treatment with the vaccine induced an anti-tumor
immune response, which predicted a favorable clinical response," said David
Berd, M.D., principal investigator, inventor of the AC Vaccine, and Professor of
Medicine, Kimmel Cancer Center, Thomas Jefferson University. "We believe the
additional results from studies in ovarian cancer demonstrate the robust nature
the AC Vaccine technology."
All patients were tested for delayed-type hypersensitivity (DTH), a
measure of the activity of T-lymphocytes (i.e., cells that are crucial in
triggering the body's immune system) before O-Vax treatment and two-and-half
weeks after the final vaccine dose. Anti-tumor immune responses (DTH) were
observed in eight of the nine patients in the first trial, and six of the eight
patients in the second trial. No serious adverse events occurred, and all
patients developed expected inflammatory papules at the injection site.
"These findings are very encouraging and bode well for further
investigation of the clinical utility of the AC Vaccine technology in ovarian
cancer patients, as well as other forms of cancer," said Jeffrey M. Jonas, M.D.,
president and chief executive officer, AVAX Technologies, Inc. "Based on these
results, AVAX has embarked on a comprehensive clinical trial program to conduct
several Phase 2 trials, one of which is being sponsored by the National Cancer
Institute."
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O-Vax is AVAX Technolgies' AC Vaccine for the treatment of advanced
ovarian cancer. Ovarian cancer is one of the most common gynecologic cancers
with more than 25,000 new cases each year. According to Cancer Care,
approximately one in 70 women will develop ovarian cancer in her lifetime, with
the risk increasing with age. O-Vax is made from the patient's own cancer cells
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.
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 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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