AVAX Technologies Announces the Commencement of Two Clinical Trials; Positive Results in Patients Treated With M-Vax Presented a
2005年7月14日 - 12:18AM
ビジネスワイヤ(英語)
AVAX Technologies, Inc. (OTCMarket: AVXT.OB) today announced it has
initiated enrollment to its clinical trial of M-Vax for the
treatment of patients with Stage III and IV melanoma in the United
States. The study is a multi-center trial that will include up to
seven clinical sites. In addition, the Company has initiated a
clinical trial in patients with metastatic peritoneal cancer in
France. Both studies will measure safety and include an
immunological measure of vaccine activity as measured by Delayed
Type Hypersensitivity Testing (DTH). To assist in the performance
and evaluation of the U. S. study, the Company has established a
Data Safety Monitoring Board. David Berd, MD, Chief Medical Officer
of AVAX stated, "We are pleased to be able to begin these important
clinical studies which reestablish AVAX's clinical development
program for the AC Vaccine and we acknowledge the support and
assistance of our clinical sites and our Data Safety Monitoring
Board in helping us to successfully launch these programs." In
addition, the Company reported that Dr. David Berd participated in
an international investigators meeting in Lyon, France that was
sponsored by GROUPO FERRER, S.A., the Company's distribution
partner for the AC Vaccine in a number of countries in Europe and
Latin America. Following Dr. Berd's talk, Dr. J-P Hermanne, Head of
Hemato-Oncology, CHR Namur, Belgium and Dr. Luis Miguel Real,
Technical Director, NeoCodex, Seville, Spain, gave presentations on
the immunological and clinical effects seen in melanoma patients
treated with M-Vax. Dr. Andres Crespo, General Manager of
Genopoietic, AVAX's wholly owned French subsidiary, stated "We were
very impressed with the presentations given at the symposium. The
clinical and immunological data presented by the clinicians
demonstrated a clear consistency with the historic findings
published previously by Dr. Berd." Both doctors have been treating
patients on a compassionate basis with Stage III & IV melanoma.
Richard Rainey, President of AVAX noted "With the closing of our
private placement in April and the launching of our clinical
programs we are in position to build our organization and continue
to explore the utility of the vaccine. In addition to our existing
clinical programs, we are also planning clinical trials in France
and the United States that will include lung cancer and metastatic
colon and ovarian cancers. Initiation of these programs will allow
us to build momentum towards the commercial launch of our vaccine
in addition to demonstrating the universal applicability of the AC
Vaccine as a platform technology for the treatment of cancer".
Information for Patients Patients and clinicians interested in
learning more about the current clinical trial of melanoma or who
want a list of the participating sites may contact Dr. David Berd
at (215) 241-9760 X1306. About AVAX Technologies, Inc. AVAX
Technologies, Inc. is a biotechnology company with operations in
the United States and Europe. The Company is engaged in the
research, clinical and commercial development of biological
products and cancer therapeutics. AVAX's AC Vaccine platform is a
therapeutic treatment for cancer. In addition, the Company performs
contract-manufacturing services for biological products to other
pharmaceutical and biotechnology companies. The AC Vaccines
therapeutic is prepared by attaching a small chemical to the
patient's tumor cells in a process known as haptenization. This
hapten modification allows the tumor cells to stimulate a T
cell-based immune response to a patients own tumor cells. An early
indicator of T cell immune activity is DTH. A previously published
article in the Journal of Clinical Oncology, February 2004 reported
actual five-year survival data for a group of 214 patients with
clinically evident Stage III melanoma treated with the AC Vaccine
following surgery. The study demonstrated five-year survival of 45%
and showed a highly statistically significant relationship between
survival and DTH to patients' own tumor cells. Notably, based upon
these results, DTH appears to be a viable "surrogate marker" for
survival and an early indicator for clinical effectiveness of
current and future product candidates. Previously clinical trials
in ovarian and renal cell carcinoma, demonstrated strong DTH
responses consistent with those reported for melanoma patients.
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 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 prospects, including (1) the results of clinical and
laboratory testing of its vaccine technologies, (2) possible future
FDA or AFSSAPS questions regarding the Company's products and
manufacturing processes, (3) the Company's need for additional
capital in the future to continue its development programs, (4) the
Company's ability to maintain its rights under license agreements
and to meet funding requirements under its license agreements, (5)
the Company's ability to demonstrate the safety and efficacy of
product candidates at each stage of development and to meet
applicable regulatory standards and receive required regulatory
approvals, (6) the Company's ability to manufacture, receive and
ship its vaccine products for clinical and commercial distribution,
as well as other risks detailed from time to time in AVAX's public
disclosure filings with the Securities and Exchange Commission,
including its Annual Report on Form 10-KSB for the year ended
December 31, 2004. AVAX does not undertake any obligation to
release publicly any revisions to these forward-looking statements
or to reflect the occurrence of unanticipated events.
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