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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 27, 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 III clinical trial for M-Vax(TM), a therapeutic vaccine for melanoma based
on its core AC Vaccine technology. Following an earlier meeting with the U.S.
Food and Drug Administration to discuss the proposed Phase III clinical trial,
AVAX has moved forward with a multi-center efficacy trial for the M-Vax
therapeutic vaccine in patients with melanoma in whom tumors have spread to
their lymph nodes. The multi-center Phase III trial will have as a senior
principal investigator Dr. David Berd, a Clinical Oncologist and Professor of
Medicine at Jefferson Medical College and Thomas Jefferson University Kimmel
Cancer Center in Philadelphia.
Reference is made to AVAX's related press release attached hereto as
Exhibit 99.2 and incorporated by reference herein.
Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits
(c) Exhibits:
99.2 Press Release dated October 27, 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 27, 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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99.2 Press Release dated October 27, 1997.
3
EXHIBIT 99.2
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 27, 1997
AVAX INITIATES PHASE III TRIAL FOR M-VAX(TM); ONLY THERAPEUTIC CANCER
VACCINE KNOWN TO SIGNIFICANTLY INCREASE SURVIVAL RATE FOR MELANOMA
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Phase III Results Pivotal in FDA Approval Process; AC Vaccine for Stage 3
Melanoma Demonstrates 5-Year Survival Rate of 58% vs. 20% Historical Based on
Phase I/II Data
KANSAS CITY, Missouri, October 27, 1997 -- AVAX Technologies, Inc. (Nasdaq
SmallCap: AVXT) today announced the Company has initiated a Phase III clinical
trial for M-Vax(TM), a therapeutic vaccine for melanoma based on the Company's
core AC Vaccine technology. The Company and its researchers believe this to be
the first therapeutic cancer vaccine to show a substantial increase in the
survival rate for patients with stage 3 melanoma.
The announcement follows the Company's earlier meeting with officials from the
Center for Biologics Evaluation and Research of the U.S. Food and Drug
Administration (FDA). Following this meeting to discuss the proposed Phase III
clinical trial, the Company has moved forward with a multi-center efficacy trial
for the M-Vax therapeutic vaccine in patients with melanoma in whom tumors have
spread to their lymph nodes.
Phase III Trial to Allow for Early Approval
The prospectively randomized Phase III study seeks to provide evidence that
M-Vax is superior to high-dose alpha interferon, currently the only FDA-approved
therapy for these patients. The measured outcomes will be disease progression
and overall survival. The study allows for a planned early analysis, comparing
time to disease progression between patients randomized to treatment with M-Vax
and patients randomized to alpha interferon.
-more-
Should this early analysis show that time to disease progression in the group
treated with M-Vax is clearly greater than that observed in the comparison
group, AVAX will seek to obtain Marketing Clearance before completion of the
full Phase III study.
"We are pleased to have started Phase III patient enrollment for M-Vax," said
president and chief executive officer, Jeffrey M. Jonas, M.D. "Initiating a
Phase III trial is pivotal for establishing the effectiveness of the Company's
core AC Vaccine technology as we develop a family of products for treating a
variety of cancers, focusing initially on a therapeutic vaccine for melanoma."
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Leading Melanoma Researcher to Participate in Phase III Trial
The multi-center Phase III trial will have as senior principal investigator Dr.
David Berd, a Clinical Oncologist and Professor of Medicine at Jefferson Medical
College and Thomas Jefferson University (TJU) Kimmel Cancer Center in
Philadelphia. Dr. Berd is Chairman of the AVAX Scientific Advisory Board and the
inventor of the AC Vaccine technology licensed from TJU for 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 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
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. Following standard surgical removal of the tumors, patients were treated
with the AC Vaccine on a monthly or weekly schedule.
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.
An unexpected finding was the significantly better survival of older patients.
The researchers projected that the 5-year survival rate of patients over 50 was
71%, versus 47% for those under 50. Also, a delayed-type hypersensitivity (DTH)
response to unmodified autologous melanoma cells was associated with a
significantly longer 5-year survival rate of 71%, versus 49% for those who did
not show the DTH response. Further, the median survival time from the date of
first recurrence of the disease was at least 19.4 months for patients whose
subcutaneous recurrence demonstrated an inflammatory response, versus 5.9 months
for those without such a response.
-more-
Only Minor Side Effects Seen in AC Vaccine Patients
It was also reported that only relatively minor side effects, such as mild,
temporary nausea and soreness or swelling at the site of the application of the
AC 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.
Disease Demographics for Melanoma
Melanoma, a form of skin cancer, is one of the deadliest types of cancer in its
later stages once it has metastasized. Melanoma is also one of the
fastest-increasing types of cancer in the U.S., according to the American Cancer
Society, which estimates that 40,300 people will be diagnosed with melanoma and
7,300 people will die from the disease in 1997.
Since 1973, the incidence rate of melanoma has increased about 4% per year from
5.7 per 100,000 in 1973 to 12.2 per 100,000 in 1993. A major risk factor for
melanoma is believed to be overexposure to ultraviolet radiation, particularly
among fairer-skinned people. The 5-year historical (surgery-only) survival rate
for clinical stage 3 malignant melanoma, based on published data, is
approximately 20%.
Company and Product Technology Overview
M-Vax is one of several therapeutic vaccines for cancer based on the Company's
core AC Vaccine technology under development by AVAX Technologies. The Company
recently announced a Phase II study in ovarian cancer patients. In addition to
AC Vaccines for 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
<PAGE>
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.
-more-
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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