http://www.pharmafrontierscorp.com/toxavin.php Tovaxin™

Tovaxin MS Vaccine Tovaxin™ is a novel T-cell therapeutic vaccine that parallels the concept of autologous cancer vaccines. Instead of modifying cancerous cells, TovaxinTM consists of attenuated autoreactive T cells. Attenuation of these cells during the vaccine production process renders the cells non-replicating but viable and causes them to elicit an immune response when injected subcutaneously into the patient. This immune response is directed against T cells within the patient that are self-reactive with myelin. This immune response, directed against a specific subset of autoreactive T cells, greatly reduces the number of these autoreactive cells in MS patients. TovaxinTM has considerable potential because it attacks the underlying cause of MS rather than just addressing its symptoms. Tovaxin™ Clinical Trials Tovaxin™ is currently being evaluated in two Phase I/II clinical trials under an Investigational New Drug (IND) application. One trial is a 9 patient dose escalation study designed to further evaluate toxicity, tolerability and clinical efficacy of the vaccine. Patient enrollment for this study began in June 2002 and is scheduled to be completed in 2005. The second trial is a Phase II open-label, retreatment study of up to 50 patients who received clinical benefit from Tovaxin™ in previous Phase I/II studies of this product, and who have been treated or could not tolerate standard treatments for MS. Each patient will receive two treatments with Tovaxin™. This study is designed to further study the safety and tolerability of Tovaxin™ in MS patients, to perform preliminary evaluation of the timing of booster doses for subsequent studies, and to evaluate efficacy.