Advaxis, Inc. reported preliminary data on the safety and clinical benefit of ADXS-HPV from an ongoing randomized Phase 2 trial of ADXS-HPV with or without cisplatin in Indian women with recurrent/refractory cervical cancer who have failed cytotoxic therapy. The advanced cervical cancer study is being conducted at 17 sites in India, and as of January 25, 2012, 87 out of a planned 110 patients have been enrolled in the study. To be enrolled in the study, all patients must have been previously treated with radiation, and/or chemotherapy, and the cancer must have resumed growth and in most cases has metastasized, as confirmed by CT or radiologic scan. The initial safety and objective response data for this ongoing study were presented at the AACR New Horizons in Cancer Research: Biology to Prevention to Therapy conference Gurgaon, Delhi (NCR), India on December 14, 2011. The objectives of this Phase 2 trial are to assess the safety and efficacy of ADXS-HPV (1x10(9) cfu) with and without cisplatin (40 mg/m(2)) and to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy. As of January 20, 2012, 87 patients have received 195 doses of ADVS-HPV. 34% of patients (a total of 30) have experienced a ADXS-HPV drug-related adverse event, consisting of Grade 1 or 2 events that were transient, comprised of non-cumulative flu-like symptoms that responded to symptomatic treatment, or resolved on their own; and 1 Grade 3 event. The primary efficacy endpoint of this Phase 2 trial is overall survival. As of January 25, 2012, the percentage of patients alive at 6 months is 62% (34/55); at 9 months is 41% (15/37) and at 1 year is 40% (6/15). Clinical responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (>=30% reduction in tumor burden) documented to date, which expands on the preliminary data presented at the AACR meeting in December that reported 1 complete response and 3 partial responses.