Advaxis, a clinical-stage biotechnology company, has enrolled 40 patients in the second of three dose cohorts in a Phase 2 dose escalation study evaluating the safety and efficacy of ADXS-HPV to treat cervical intraepithelial neoplasia (CIN) 2/3.
The patients in cohort two of the Lm-LLO-E7-07, single blind, placebo-controlled study were randomised 3:1 to ADXS-HPV (three doses at 3.3×108 cfu) or placebo.
Advaxis science and operations executive vice president, John Rothman, said the company continues to meet major milestones in its clinical development plan.
"We look forward to assessing the results of the second cohort of this study and to advancing the development of ADXS-HPV for the treatment of HPV-associated diseases," Rothman added.
The dose of ADXS-HPV in the second cohort is six times higher than that of the first cohort, according to the company.
Patients are observed for six months after the last dose, prior to undergoing the standard of care surgery (LEEP) required for the treatment of the disease.
The company expects to report the safety and efficacy results once all patients have completed LEEP.
The primary objective of the study, which consists of three cohorts, is to determine a safe dose of ADXS-HPV for the treatment of CIN 2/3.
Advaxis reported data from the first cohort, which consisted of 41 patients, randomised 3:1 ADXS-HPV (three doses at 5×107 cfu) or placebo, in February 2012.
No serious adverse events were experienced in the first cohort, whereas 29% (9/31) of patients experienced side effects that were related, or possibly related, to treatment.
The data showed that 52% of CIN 2/3 lesions regressed from CIN 2/3 to CIN 1 or normal in the ADXS-HPV arm and 40% of CIN 2/3 lesions spontaneously regressed in the placebo arm.