The year 2010 was very important for Genovax projects. In fact for the project GX101 (lupus) we completed the planned five mice experiments. We have now a clear idea of vaccination efficacy in relationship to disease status, and the best timing to perform the vaccination.

We had a pre-IND meeting with experts of Italian Health Authorities, who confirmed our studies plan to file an IND application, in order to start a clinical study. We are now organizing the work, which will be out-sourced, for both the preclinical studies and the GLP/GMP preparation of the plasmide, to be produced at the facilities of an AIFA/FDA approved company.

Regarding the GX301 project ( kindney and prostate carcinoma) we are collecting very interesting data. The clinical study was activated in February 2010, and recruited 11 patients (9 prostate and 2 kidney): tolerability is very good, and we documented signs of clinical and immunological responses. The initial patients, who were vaccinated in February and March 2010, are already in the 10th-11th month of survival, with a very good quality of life, as they were able to stop analgesic therapy. The clinical study is progressing, and we foresee to complete, at the beginning of 2011, the planned 10 prostate patient. We will then move to a Phase IIa study, in patients with less advanced disease status.

December 2010