Advaxis has reported the preliminary data on the safety and clinical benefit of ADXS-HPV with or without cisplatin in Indian women with recurrent / refractory cervical cancer who have failed cytotoxic therapy from an ongoing randomised Phase II trial.
The advanced cervical cancer study enrolled 87 of a planned 110 patients who have been previously treated with radiation, and/or chemotherapy, and the cancer must have resumed growth and in most cases have metastasised, as confirmed by CT or radiologic scan. The goal of the Phase II trial is to evaluate the safety and efficacy of ADXS-HPV with and without cisplatin (40mg/m²) and to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy.
To date, 87 patients have received 195 doses of ADVS-HPV, of which 34% experienced an 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 one grade 3 event.
In the trial, the primary efficacy endpoint is overall survival, and clinical responses have been observed in both treatment arms with three complete responses and four partial responses. The study showed that percentage of patients alive at six months was 62%, at nine months 41% and at a year 40%.
The preliminary data of the Phase II study is presented at the World Cancer Immunotherapy Conference in San Diego, California on 25 January 2012.
Advaxis, a clinical-stage biotechnology company, is developing the next generation of immunotherapies for cancer and infectious diseases based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein. Currently, ADXS-HPV is being evaluated in four Phase II clinical trials for HPV-associated diseases with over 150 patients receiving over 360 doses to date.