[MOL] {ositive results obtained with low-doe M-Vax in ''''''''''''''''me [01857] Medicine On Line


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[MOL] {ositive results obtained with low-doe M-Vax in ''''''''''''''''metastatics



Positive Results Obtained with Low-Dose M-Vax In Metastatic Melanoma



KANSAS CITY, MO -- March 15, 2000 -- AVAX Technologies, Inc. announced interim results from a low-dose Phase 2 study of M-Vax(TM), a therapeutic cancer vaccine for post-surgical, stage III metastatic melanoma made by modifying a patient's own tumor cells with a molecule called a "hapten." The purpose of the study, which is ongoing, is to evaluate M-Vax's ability to stimulate an immune response against a patient's own tumor cells utilizing a lower vaccine dose than previously tested. Lowering the vaccine dose reduces the amount of tumor tissue required for manufacturing and thereby expands the number of eligible patients.

Preliminary results from 23 patients demonstrate that 65% of the patients responded favorably to the lower dose, as measured by a delayed type hypersensitivity test (DTH), a skin test that measures a patient's immune response against the patient's own tumor cells. The data obtained from this study to date show the same magnitude of positive immunologic responses as seen after higher dose M-Vax treatment in earlier studies. Results in these earlier studies indicated a strong correlation between positive clinical
outcomes and M-Vax's ability to induce an immunological response against a patient's own tumor cells. Follow-up of over 350 patients to date continues to support this correlation.

This low-dose M-Vax study is being conducted by David Berd, M.D., Professor of Medicine, Thomas Jefferson University in Philadelphia, and will involve a total of 46 patients receiving seven doses of M-Vax over a seven-week period and given a DTH test one month after their last weekly vaccination. Currently, 32 patients have been enrolled, with interim data available from 23 patients.

Jeffrey M. Jonas, M.D., President and CEO of AVAX Technologies, Inc., stated, "The interim data gathered from this revealing study continue to support earlier results that indicate M-Vax is successful in stimulating a patient's immune system to attack cancer cells. More importantly, this study demonstrates that we can achieve this important immunologic response with a lower dose. This finding is especially significant since the lower dose requires only half the tumor used in previous studies to prepare the vaccine.
As a result of this key discovery, we have modified our ongoing, multicenter, pivotal registration trial of M-Vax to use the low-dose M-Vax regimen, which we believe enhances our ability to treat additional patients who may have been previously excluded from the study due to the size of their tumor."

AVAX Technologies, Inc. specializes in the development and commercialization of novel biotechnologies, immunotherapies and pharmaceuticals for cancer and other life-threatening diseases using three core technologies: autologous cell (AC) vaccines, topoisomerase inhibitors and anti-estrogens.




Warmly, lillian

 
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