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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
December 8, 1997
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. ("AVAX") announced today it has established
a certified processing facility using AVAX's core AC (autogolous cell) Vaccine
technology at the Thomas Jefferson University Kimmel Cancer Center in
Philadelphia. This interim facility will initially produce M-VAX(TM), AVAX's
therapeutic vaccine for melanoma which recently entered a Phase III clinical
trial. The facility will also be used to produce therapeutic vaccines for
additional types of cancer, under clinical trials, including O-Vax(TM), the
Company's AC Vaccine for ovarian cancer.
Reference is made to AVAX's related press release attached hereto as
Exhibit 99.3 and incorporated by reference herein.
Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits
(c) Exhibits:
99.3 Press Release dated December 8, 1997.
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: December 8, 1997
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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99.3 Press Release dated December 8, 1997.
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EXHIBIT 99.3
AVAX Technologies, Inc.
4520 Main Street, Suite 930
Kansas City, MO 64111
www.avax-tech.com
Nasdaq SmallCap: AVXT
At AVAX Technologies:
Jeffrey M. Jonas, M.D. David L. Tousley, C.P.A. Ernest W. Yankee, Ph.D.
President & CEO Chief Financial Officer Exec.V.P.-Med. & Reg. Affairs
Phone (816) 960-1333 Phone (816) 960-1333 Phone (816) 960-1333
[email protected] [email protected] [email protected]
At The Financial Relations Board:
Paul Scheeler Robb Kristopher Alicia Nieva-Woodgate
General Information Analysts/Investors Media Inquiries
Phone (312) 640-6742 Phone (312) 640-6669 Phone (212) 661-8030
[email protected] [email protected] [email protected]
FOR IMMEDIATE RELEASE
MONDAY, DECEMBER 8, 1997
AVAX ESTABLISHES INITIAL CANCER VACCINE PROCESSING FACILITY
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Philadelphia's Kimmel Cancer Center at Thomas Jefferson University Home
to New Production Facility for AC Vaccine(TM) Using Patients' Own Tumor
Cells to Fight Cancer; Initial Focus is Company's AC Vaccine for Melanoma,
M-Vax(TM), Now in Phase III Trial
KANSAS CITY, Missouri, December 8, 1997 -- AVAX Technologies, Inc. (Nasdaq
SmallCap: AVXT) announced today it has established a certified processing
facility using the Company's core AC Vaccine technology at the Thomas Jefferson
University Kimmel Cancer Center in Philadelphia, one of the country's leading
cancer research centers. The $200,000 facility, financed by AVAX, includes cell
bank capability and state-of-the-art vaccine processing systems with a Class
10000 clean room which is certified to meet required federal standards.
AVAX's AC (autologous cell) Vaccine technology produces an individualized
vaccine immunotherapy using a cancer patient's own tumor cells. This interim
facility will initially produce M-Vax(TM), AVAX's therapeutic vaccine for
melanoma which recently entered a Phase III clinical trial. The TJU facility
will also be used to produce therapeutic vaccines for additional types of
cancer, under clinical trials, including O-Vax(TM) for ovarian cancer.
"Currently this is the country's only human tumor processing facility for
autologous cell vaccines which meets federal standards and the first cancer
vaccine production facility in the Philadelphia area," noted Dr. David Berd, a
Clinical Oncologist and Professor of Medicine at Jefferson Medical College and
TJU. "This facility will provide AC Vaccine for a portion of the approximately
250 melanoma patients we expect to enroll in the multi-center Phase III trial
for M-Vax starting this fall."
Dr. Berd is the inventor of the AC Vaccine technology under development by AVAX
as well as Chairman of the Company's Scientific Advisory Board. AVAX has
licensed the exclusive rights to the AC Vaccine technology from Dr. Berd and
TJU. Berd is serving as senior principal investigator for a Phase III trial of
M-Vax and has conducted several Phase I/II physician-sponsored clinical trials
for the treatment of malignant melanoma using the AC Vaccine at TJU over the
past several years.
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AVAX President and Chief Executive Officer, Jeffrey M. Jonas, M.D., said: "This
facility will provide sufficient quantities of the AC Vaccine for our Phase III
trial for melanoma and, potentially, other cancers. The strategic location at
the TJU Kimmel Cancer Center enables us to rapidly process vaccine for the
significant number of patients served by this institution as well as patients at
other locations in the continental U.S. This allows us to take a significant
step toward establishing the effectiveness and commercial viability of the
Company's core AC Vaccine technology as we develop a family of products for
treating a variety of cancers."
TJU Facility to Provide AC Vaccine for Phase III Trial of M-Vax
On October 27, 1997, the Company announced it had begun a multi-center Phase III
clinical trial for M-Vax. This trial is a large, national efficacy study of
patients with advanced (stage 3) melanoma in whom tumors have spread to their
lymph nodes. The Company and its researchers believe M-Vax to be the first
therapeutic cancer vaccine to show a substantial increase in the survival rate
for patients with stage 3 melanoma. The Company also started a Phase II clinical
trial for O-Vax, the AC Vaccine for ovarian cancer, in October.
Patients are treated with the AC Vaccine weekly for six weeks. The preparation
of the vaccine involves removing tumor cells from the patient and modifying them
with a small molecule known as a hapten. The product, when administered to the
same patient, is believed to stimulate the patient's immune system to prevent
regrowth of the cancer.
Results of Phase I/II Trials of M-Vax, the AC Vaccine for Melanoma
In the June, 1997 issue of The Journal of Clinical Oncology, a leading cancer
research publication, Dr. Berd reported the results of treatments on 62 patients
with metastases in a single lymph node area (stage 3) which showed that 36 were
still alive after a median follow-up time of 55 months. These patients ranged in
age from 26 to 79 years old. The projected 5-year relapse-free and overall
survival rates for these patients were 45% and 58%, respectively.
The purpose of the ongoing research has been to determine whether such a
treatment is effective for melanoma patients whose tumors have spread to lymph
nodes. Only relatively minor side effects have been witnessed to date, such as
mild, temporary nausea and soreness or swelling at the site of the application
of the AC Vaccine. These mild side effects were almost entirely attributable to
the cyclophosphamide or BCG adjuvants used in administering the vaccine.
Preliminary Results of Clinical Trials of O-Vax, the AC Vaccine for Ovarian
Cancer
October 13, 1997, AVAX announced preliminary results of a Phase II clinical
trial for O-Vax, the Company's therapeutic vaccine for advanced ovarian cancer.
That study's objective is to determine whether the vaccine induces an immune
response in humans. In the first several patients, the results have been
positive: all developed an immune response to their own cancer cells as measured
by delayed-type hypersensitivity (DTH).
DTH is a measure of the function of T lymphocytes, which are considered critical
to the immunologic destruction of cancer cells. In previous studies of the AC
Vaccine in melanoma patients, there was a highly significant correlation between
a positive DTH response and progression-free as well as overall survival.
For ovarian cancer, tumor tissue is removed from the abdominal cavity. Following
administration of chemotherapy, patients receive AC Vaccine. Investigators hope
that the vaccine treatment will increase the conventional therapy cure rate for
ovarian cancer from its current level of approximately 20%.
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Company and Product Technology Overview
M-Vax and O-Vax are among several therapeutic vaccines for cancer based on the
Company's core AC Vaccine technology under development by AVAX Technologies. In
addition to AC Vaccines for melanoma, ovarian and other cancers, AVAX 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.
Cautionary Statement
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 the Company's pharmaceutical products;
government regulation and approval by the FDA of the Company's products for sale
in the U.S.; 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; possible 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.
For additional information on AVAX Technologies toll-free via fax,
simply dial 1-800-PRO-INFO, follow the voice menu prompts
and enter the company code "AVXT" on any touch tone phone.
Visit the AVAX Technologies website at: www.avax-tech.com
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