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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
October 13, 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 initiated a
Phase II clinical trial for O-VAX(TM), its therapeutic vaccine for advanced
ovarian cancer. The Phase II trial for O-VAX(TM) is being conducted by Dr. David
Berd, a Clinical Oncologist and Professor of Medicine at Thomas Jefferson
University Cancer Center in Philadelphia. The preparation of the vaccine
involves removing the tumor cells from the patient and modifying them with a
small molecule, dinitrophenyl, which makes the cells more easily recognized by
the immune system. The product, when administered to the same patient, is
believed to stimulate the patient's T lymphocytes to prevent regrowth of cancer.
Additionally, the Gynecologic Oncology Group, the largest network of
cancer centers, hospitals and doctors conducting clinical trials in gynecologic
oncology funded by the National Cancer Institute, has expressed an interest in
sponsoring an expanded Phase II trial to be conducted in the near future.
Reference is made to AVAX's related press release attached hereto as
Exhibit 99.1 and incorporated by reference herein.
Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits
(c) Exhibits:
99.1 Press Release dated October 13, 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: October 14, 1997
By: /s/ Jeffrey M. Jonas
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Name: Jeffrey M. Jonas, M.D.
Title: President and Chief Executive Officer
2
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Exhibit Index
Exhibit Number Description
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99.1 Press Release dated October 13, 1997.
3
EXHIBIT 99.1
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 Analyst Inquiries Media Inquiries
Phone (312) 640-6742 Phone (312) 640-6669 Phone (212) 661-8030
[email protected] [email protected] [email protected]
FOR IMMEDIATE RELEASE
MONDAY, OCTOBER 13, 1997
AVAX STARTS PHASE II TRIAL OF O-VAX(TM) OVARIAN CANCER VACCINE
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Latest Therapeutic Vaccine Based on Company's Core AC Vaccine Technology
Kansas City, Missouri, October 13, 1997 -- AVAX Technologies, Inc. (Nasdaq
SmallCap: AVXT) announced today it has initiated a Phase II clinical trial for
O-Vax(TM), the Company's therapeutic vaccine for advanced ovarian cancer. The
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.
These preliminary results were discussed with the Gynecologic Oncology Group
(GOG) in New Orleans in August, 1997. The GOG, the largest network of cancer
centers, hospitals and doctors conducting clinical trials in gynecologic
oncology funded by the National Cancer Institute (NCI), has expressed interest
in sponsoring an expanded Phase II trial to be conducted in the near future.
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President and Chief Executive Officer Jeffrey M. Jonas, M.D., commented: "We are
pleased to have started a Phase II trial for O-Vax. This demonstrates the
Company's ability to apply the AC Vaccine technology to a second form of cancer.
This study also demonstrates that the AC Vaccine technology can elicit an active
immune response against ovarian cancer, previously only demonstrated against
melanoma. This is an essential step in AVAX's development of a family of
products for treating a variety of cancers and other life-threatening diseases,
including ovarian cancer."
Leading Cancer Researcher Oversees Phase II Trial
The Phase II trial for O-Vax is being conducted by Dr. David Berd, a Clinical
Oncologist and Professor of Medicine at Thomas Jefferson University (TJU) Cancer
Center in Philadelphia. Dr. Berd is Chairman of the AVAX Scientific
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Advisory Board and the inventor of the AC Vaccine technology licensed and under
development by AVAX.
Dr. Berd 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. The preparation of the vaccine involves removing tumor cells
from the patient and modifying them with a small molecule, dinitrophenyl (DNP),
which makes the cells more easily recognized by the immune system. The product,
when administered to the same patient, is believed to stimulate the patient's T
lymphocytes to prevent regrowth of the cancer.
The purpose of the ongoing melanoma research has been to determine whether such
a treatment is effective for patients whose tumors have spread to lymph nodes.
Following standard surgical removal of the tumors, patients were treated with
the AC Vaccine on a monthly or weekly schedule. 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%.
Previous Results of Phase I/II Trials of the AC Vaccine
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 melanoma
patients with metastases in a single lymph node area (stage III) 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.
Only relatively minor side effects, such as mild, temporary nausea or soreness
and swelling at the site of application of the vaccine, have been witnessed to
date. These mild side effects were almost entirely attributable to the
cyclophosphamide or BCG adjuvants used in administering the vaccine. Based on
the results from these Phase I/II trials, AVAX expects to initiate a
multi-center Phase III trial in melanoma patients in the near future.
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Disease Demographics for Ovarian Cancer
Ovarian cancer accounts for approximately 4% of the nearly 600,000 new cases of
cancer diagnosed annually among women in the U.S., according to the American
Cancer Society, which estimates there will be 26,800 new cases and 14,200 deaths
from the disease in 1997. The 5-year relative survival rate for ovarian cancer
is 92% with early diagnosis and treatment, but only 24% of all cases are
detected at the localized stage. Most patients present with more advanced cancer
that has spread to the abdominal cavity.
Company and Product Technology Overview
O-Vax is one of several therapeutic vaccines for cancer based on the Company's
core AC Vaccine technology. 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
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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 at no charge,
simply dial 1-800-PRO-INFO and enter the code "AVXT".
Visit the AVAX Technologies website at: www.avax-tech.com
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