Advaxis has reported the results of phase I trial of ADXS11-001, the company’s lead vaccine candidate. The study showed 36 month survival in two of the 13 evaluable patients, indicating the possibility of persistent immune protection, from a two dose initial regimen.
ADXS11-001 is a therapeutic vaccine, unlike currently marketed prophylactic vaccines, that treats women who have already developed cervical cancer as a result of human papilloma virus (HPV) infection.
Reportedly, the patients had participated in the first human trial of a live Listeria vaccine for the treatment of advanced, recurrent, metastatic cervix cancer in women, who have failed prior cytotoxic treatment. Advaxis is tracking the survival of these patients at three month intervals.
Earlier this year, Advaxis published in the medical journal, Vaccine, the fact that four of 13 evaluable patients treated with ADXS11-001 experienced tumor reductions, two patients had lesions disappear and 53% survived more than one year; thus, posting a median survival rate of 347 days.
Although the trial was designed to assess safety not efficacy or survival, two of the 13 patients or 15% evaluable for efficacy are still alive, at over 1,000 days post-dosing with the study drug, as of December 10, 2009, said the company.