Genticel starts Phase I trial of GTL001 against HPV 16/18 infections

29th October 2015 (Last Updated October 29th, 2015 18:30)

Genticel has started the US Phase I clinical trial of GTL001, a first-in-class therapeutic vaccine candidate against human papillomavirus (HPV) 16/18 infections.

Genticel has started the US Phase I clinical trial of GTL001, a first-in-class therapeutic vaccine candidate against human papillomavirus (HPV) 16/18 infections.

The French biotechnology firm develops new immunotherapies to prevent cancers caused by HPV.

Patients in the Phase I trial are infected with HPV 16 and/or 18, which cause 70% of cervical cancer cases.

"Recruitment is thus in pace with our objective of delivering the trial results during the first half of 2016.”

Phase I is being conducted at three investigational sites in the US, and is designed to evaluate GTL001's safety and tolerance profile in 20 women aged from 25 to 65. The trial will therefore include older women than those previously studied in Europe.

Genticel chief medical officer Sophie Olivier said: "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."

GTL001 already achieved encouraging results in a Phase I trial on 47 patients in Europe. The first results of the European Phase II trial on 239 patients will be available in the first half of next year.

Genticel chief executive officer Martin Koch said: "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."

Genticel recently secured positive preclinical proof of concept results for its second therapeutic vaccine candidate, GTL002 (Multivalent HPV), which targets the six most oncogenic HPV types.

The company noted that GTL002 will be ready for a Phase I trial in 2017.

With both GTL001 and GTL002 in the pipeline, Genticel is claimed to be the first to develop HPV vaccine therapeutics for millions of infected women, for whom no treatment is currently available.