Norwegian Vaccibody AS announces enrolment of all twelve patients required for the phase I part of the multicentre trial VB C-01 – an exploratory, open-label, multicenter phase I/IIa study of VB10.16 immunotherapy for the treatment of high grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV 16).
As per protocol twelve eligible patients are needed to study the safety and immunogenicity of two different dosing schedules of VB10.16 in patients diagnosed with CIN 2 during this first phase I part of the study. Patient number 12 received her first vaccination on Friday 26 February 2016. The best schedule will be selected and evaluated in the subsequent phase IIa expansion part in both CIN 2 and CIN 3 patients.
The primary objective of the study is to evaluate the safety and tolerability of three doses of 3 mg VB10.16. The secondary objectives are to assess T cell mediated immune responses in the peripheral blood as well as in the pre-malignant tissue of the CIN 2/3 lesions and to evaluate early signs of efficacy by means of HPV clearance and CIN regression.
Martin Bonde, CEO of Vaccibody, commented: “The successful completion of enrolment of the required number of patients for the phase I part of the study is an important milestone for Vaccibody. Positive results from this trial will have a significant impact not only on the development of the company’s lead product VB10.16 but also represent a proof of principle for Vaccibody’s Vaccine Platform Technology and the potential to use this platform in further indications.”
Source: Oslo Cancer Cluster