The National Security Agency in France and the Federal Agency for Medicines and Health Products in Belgium have granted regulatory approvals to Theravectys to initiate a Phase I/II clinical trial of its anti-HIV therapeutic vaccine.
The anti-HIV vaccine uses the biotechnology company’s lentiviral vector technology to induce the cellular immune system for the removal of infected cells.
The double-blind, controlled, placebo study will enrol 36 patients from four clinical centres in France and two in Belgium, to assess the safety and tolerance of the vaccine and measure the quality and intensity of the induced immune response.
The vaccine is being developed with the intention of stopping patients taking antiretroviral drugs on a sustainable basis after the treatment.
Cochin-Pasteur Clinical Investigation Center coordinator and coordinating investigator of the trial Pr Odile Launay said; "This study should confirm the preclinical data and the ability of the vaccine candidate, based on the result of fundamental research conducted at the Pasteur Institute, to induce an immune response against HIV."
Theravectys regulatory affairs and clinical trials in-charge Dr Emmanuelle Sabbah-Petrover said the company is planning to recruit the first patient by the end of December this year.
"Our early interactions with the French, Belgian and European regulatory agencies facilitated their investigations on our clinical trial applications," Sabbah-Petrover said.
Theravectys chief scientific officer Dr Cécile Bauche expects the clinical trials to demonstrate the safety and immunogenicity in humans within 12 months.
"This expected confirmation will not only bring tremendous hope for all HIV positive patients, but it will also open a path for new developments," Bauche said.