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Clinical trials of active vaccination in metastatic melanoma patients

clinical study dataset

We have continued recruitment of patients and obtained first data in the two clinical trials of active vaccination in metastatic melanoma. Structural works that have been performed to up-grade the GMP facility for conduction of phase III clinical trials has limited the number of patients recruited. Nonetheless, we were able to complete the vaccination schedule in 4 patients and to perform additional injections in disease free patients, in patients with stable disease or with slowly progressive disease. We could not recruit new patients because the generation in GMP conditions of additional aliquots of the vaccines (i.e. the supernatant containing the infective MAGE-3 encoding viruses and the natural tumour peptides) is taking longer then predicted because of new viral controls required by the Regulatory Agency and of difficulties in purchasing clinical grade dialysis’ membranes for peptides production. As far as the planning of new protocols concerns we are waiting to know whether grant applications we applied for the specific issues will be funded.

Thus so far the 2 clinical trials are on hold until problems in GMP production of the vaccine have been solved.





created over 9 years ago (2 March 2009)    last modified over 6 years ago (10 November 2011)   [ RDF Rdf ]   [ RelFinder Relfinder ]