AVAX to Present Results of Phase I-II Study of MVax(R) at 2008 Meeting of the American Society of Clinical Oncology (ASCO)
24 Mars 2008 - 2:21PM
Business Wire
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
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