AVAX Technologies, Inc. (AVXT) Announces Successful Completion of Phase I / II Study of MVax(R) in Patients with Stage 3 and 4 Melanoma
12/11/2007 1:16:04 PM
PHILADELPHIA & LYON, France--(BUSINESS WIRE)--AVAX Technologies, Inc. (OTC Market:AVXT.OB) announced today the completion of its Phase I/II study for the treatment of patients with melanoma. The study was designed to evaluate four doses of MVax® with dose defined by the number of cells injected in each vaccine; the doses tested were: 5x106 cells (high dose), 2.5x106 cells (medium dose), 0.5x106 cells (low dose), and 0 cells (zero dose). All dosages were administered according to a previously developed optimum schedule, which included an induction dose without adjuvant followed by low dose cyclophosphamide and then 6 doses admixed with the immunological adjuvant, BCG, Endpoints of the study were safety and an immunological endpoint of delayed-type hypersensitivity (DTH), which is a T-cell-mediated immune response to autologous melanoma cells. The study was also designed to demonstrate that the frozen formulation of MVax® is bio-equivalent to the original, freshly-prepared autologous, hapten-modified vaccine.