Genticel, a clinical-stage biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus (HPV), has announced that the first patient of the US Phase I clinical trial has been vaccinated with GTL001, the company’s first-in-class therapeutic vaccine candidate against HPV 16/18 infections.
This first vaccination follows the US Food and Drug Administration’s (FDA) clearance last June of Genticel’s Investigational New Drug (IND) application to conduct a Phase I clinical study of GTL001 in patients infected with HPV 16 and/or 18, which cause 70% of cervical cancer cases.
GTL001 already achieved encouraging results in a Phase I trial on 47 patients in Europe and the first results of the European Phase II study on 239 patients will be available in the first half of 2016.
In this US Phase I trial, Genticel is evaluating GTL001’s safety and tolerance profile in 20 women aged 25 to 65, a subject population that includes women older than those previously studied in Europe. The study is being conducted at three investigational sites in the US.
Sophie Olivier, Genticel’s Chief Medical Officer, stated: “We are very pleased with the way recruitment has taken off. The investigational study sites have been extremely diligent in enrolling patients meeting eligibility criteria, resulting in the treatment of our first patient today. Recruitment is thus in pace with our objective of delivering the trial results during the first half of 2016.”
Martin Koch, Genticel’s Chief Executive Officer, added: “The initiation of this study in the US illustrates Genticel’s global clinical development strategy for GTL001 in order to validate the vaccine’s potential as an effective treatment for the millions of women infected with HPV 16 and/or 18 who currently do not have any therapeutic option.”
Furthermore, Genticel recently obtained positive preclinical proof of concept results for the company’s second therapeutic vaccine candidate, GTL002 (Multivalent HPV), which targets the six most oncogenic HPV types. GTL002 will be ready for a Phase I trial in 2017. With GTL001 and GTL002, Genticel is the first company to develop a pipeline of HPV vaccine therapeutics for the millions of women infected by the most oncogenic types of this virus and for whom no treatment is currently available.