Phase II Clinical Trial Results Declared by Advaxis

Advaxis (ADXS) introduced that they have completed the very first of 3 dose cohorts within the single blind, placebo managed Phase II dose escalation study figuring out the protection and efficacy of ADXS-HPV in the treatment of cervical intraepithelial neoplasia (CIN) 2/3.

As a considerate reminder, Advaxis started the multicenter, randomized, single blind, placebo-controlled, Phase II clinical trial of ADXS-HPV for the treatment of cervical intraepithelial neoplasia (CIN) in April 2010. The research should assess the safety and efficacy of ADXS-HPV for the treatment of CIN grade 2/3, which is late stage cervical dysplasia that requires surgery to avoid invasive cancer. Numoda Corporation is Advaxis’ strategic partner within the conduction and direction in this trial.

The research has 3 cohorts being made of 40 affected individuals each: 30 individuals receive 3 dosages of ADXS-HPV at 50 million, 330 million or 1 billion cfu and 10 affected individuals accept 3 doses of placebo. The primary objective of this survey is to determine a safe dose of ADXS-HPV for the treatment of CIN 2/3. Efficacy is dependent upon a concluded panel of pathologists that are blinded to therapy and execute microscopic evaluations of a typical tissue eliminated at pretreatment biopsies and through their treatment surgery to ascertain if the lesions have regressed or returned to normal. Immunogenicity and HPV DNA figures will probably be collected, in the process.