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news.Advaxis has dosed the first patient in its FDA-approved, Phase II ADXS11-001 clinical trial in cervical intraepithelial neoplasia (CIN).
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Advaxis said that the study is designed to assess the safety and efficacy of ADXS11-001, for the treatment of CIN grade 2/3 commonly known as cervical dysplasia.
Reportedly, the trial is slated to be a multicenter, randomised, placebo controlled, blinded clinical trial of ADXS11-001.
ADXS11-001 is Advaxis’ lead immunotherapeutic candidate. The dosing was administered at the site of Dr Keith Aqua at the Institute for Women’s Health & Body.
Thomas Moore, chairman and CEO of Advaxis, said: “Dosing the first patient is a significant milestone for our company. It is a highly awaited development amongst all Advaxis and immunotherapy followers, at large; following the recent Dendreon FDA approval.
“We look forward to completing and reporting the first dosing leg over approximately the next fifteen (15) months.”