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Advaxis Inc evaluates higher dose and repeat cycles of ADXS-HPV in Phase 1/2 Cervical Cancer Trial


Monday, 16 Jun 2014 08:30am EDT 

Advaxis Inc:Georgia Regents University (GRU) Cancer Center has received Institutional Review Board (IRB) approval to initiate Phase 1/2 trial evaluating higher doses and repeat cycles of ADXS-HPV in patients with recurrent cervical cancer.This Phase 1/2 study is designed to evaluate the safety, efficacy and immunological effect of the highest-tolerated dose of ADXS-HPV administered in repeat cycles of treatment to patients with cervical cancer whose disease recurred after receiving one prior cytotoxic treatment regimen.Advaxis's earlier Phase 2 clinical study in 110 women with recurrent cervical cancer had already demonstrated that a single cycle (3 doses) of ADXS-HPV at a dose of 1x10(9)colony forming units (CFU) is well-tolerated with complete and partial tumor responses as well as an apparent survival benefit.Building on this data, among the purposes of this study is to evaluate the effect of repeat cycles of treatment (multiple doses) of ADXS-HPV at higher doses.