Advaxis 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 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 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 metastasized, as confirmed by CT or radiologic scan.
The objectives of this trial are to assess the safety and efficacy of ADXS-HPV (1x109cfu) with and without cisplatin (40mg/m2) and to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy. Eighty seven patients have received 195 doses of ADVS-HPV. The primary efficacy endpoint is overall survival. The percentage of patients currently alive at 6 months is 62% (34/55); at 9 months is 41% (15/37) and at one 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 preliminary data that reported 1 complete response and 3 partial responses.
ADXS-HPV is an immunotherapy that is designed to target cells expressing the HPV gene E7. Expression of the E7 gene from high-risk HPV variants is responsible for the transformation of infected cells into dysplastic and malignant tissues. Eliminating these cells can eliminate the dysplasia or malignancy.
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