AVAX Technologies, Inc. (OTC Market:AVXT.OB) announces that its
abstract, entitled, “Dose-response study of a
cryopreserved, autologous, hapten-modified melanoma vaccine (MVax®),”
has been accepted for presentation at the annual meeting of the American
Society for Clinical Oncology (ASCO) to be held May 30-June 3 in
Chicago. The abstract was selected from the over 4,800 that were
reviewed by ASCO’s Scientific Program
Committee this year.
The AVAX presentation is scheduled for June 1 in a melanoma research
session. It will be publicly posted on ASCO.org on May 15. The
presentation will describe the results of AVAX phase I-II trial of MVax®,
its autologous, hapten-modified melanoma vaccine. Details will be
publicly withheld until then, in accordance with ASCO’s
confidentiality policy.
MVax® Phase III Registration Study
AVAX’s Phase III Registration, MVALDI trial
will examine survival and anti-tumor response rate using modified
response evaluation criteria in solid tumors (modified RECIST
criteria) in Stage IV melanoma patients with soft tissue or lung
metastasis. The Phase III registration trial is being conducted under a
Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug
Administration (FDA) for MVax® and in
agreement with the FDA the company will be eligible to file for
accelerated approval of MVax® based upon
achieving a response rate endpoint. The double blind, randomized trial
is expected to enroll up to 387 patients to be accrued over a period of
24 months. Patients will be randomized on a two to one basis to the
treatment arm or control arm, respectively. The treatment arm consists
of MVax® followed by a regimen of low dose
IL-2; the control arm consists of placebo vaccine followed by low dose
IL-2. Both treatment and control arms include BCG and low dose
cyclophosphamide.
MVax® in Metastatic Melanoma
In a phase 2 clinical study published in the International Journal of
Cancer, MVax® induced tumor shrinkage in
11/83 patients with surgically incurable stage IV melanoma. In a
subsequent paper published by Dr. Michal Lotem in the British Journal of
Cancer (British Journal of Cancer 2004, 90 773-780) patients treated
with their DNP modified tumor cells, using manufacturing techniques
similar to MVax®, followed by administration
of low dose interleukin-2, achieved a response rate of 35%. These
results were confirmed in a subsequent study conducted by the same
investigator that showed a 32% response rate, including 13% complete
responses and 19% partial responses.
MVax® in Stage III Melanoma
MVax® was the subject of a publication in the
Journal of Clinical Oncology that discussed 214 Stage III melanoma
patients that were treated with a regimen of MVax®
post surgery. No patients were lost to follow-up and they were split
between Stage IIIb & Stage IIIc melanoma. All patients on study had
completed follow-up and the reported five-year survival rate was 45%.
This compares to five-year survival published in similar patient
populations who underwent surgery alone of 22%. In addition, the data
showed a significant correlation between survival and delayed-type
hypersensitivity (DTH) responsiveness to patients’
unmodified tumor cells (P<.001). The
journal commissioned an editorial on the publication. In a separate
study of a similar patient population using a DNP-modified tumor cell
vaccine (British Journal of Cancer 2002 May 20; 86(10): 1534-9), Lotem
also showed a positive relationship between survival and DTH to melanoma
cells.
About Melanoma
Cancer of the skin is the most common of cancers while melanoma accounts
for approximately 3% of skin cancer cases. According to the SEER
CanQuest Database and the American Cancer Society, in the U.S. for 2007
it is estimated there will be 59,940 new cases of melanoma with an
expected number of deaths from melanoma of 8,110. The estimated
prevalence of melanoma in the U.S. in 2007 is 396,242 cases.
Further information on the Clinical Study
To obtain further information on the phase III clinical study, please
visit www.clinicaltrials.gov
and look up MVax® or use study identifier
NCT00477906. Additionally, the study has been assigned eudraCT number
2007-004406-26 by the EMEA. You may also contact Dr. David Berd or Ellen
Bloome, RN at AVAX Technologies, Inc., 2000 Hamilton Street, Suite 204,
Philadelphia, PA 19130 (215) 241-9760.
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 cancer vaccine. In addition, the Company performs
contract-manufacturing services for biological products for other
pharmaceutical and biotechnology companies.
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) risk associated with a change in executive
management of the Company, (2) the immediate need to obtain additional
funding to continue to finance the Company’s
development plans, (3) the results of clinical and laboratory testing of
its vaccine technologies, (4) possible future FDA or AFSSAPS questions
regarding the Company's products and manufacturing processes, (5)
exchange rate risks associated with financing the Company in U.S.
dollars but funding significant operating expenses in Europe with Euro’s,
(6) the Company's ability to maintain its rights under license
agreements and to meet funding requirements under its license
agreements, (7) 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, 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. 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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