AVXT AVAX Technologies Inc (CE)

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