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Theravectys Is Planning to Initiate Phase I/II Trial of Anti-HIV Therapeutic Vaccine

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Core prompt: Theravectys has received regulatory clearances from France's National Security Agency and Belgium's Federal Agency for Medi

Theravectys has received regulatory clearances from France's National Security Agency and Belgium's Federal Agency for Medicines and Health Products to commence a phase I/II clinical trial of its anti-HIV therapeutic vaccine.

Using the company's lentiviral vector technology, the anti-HIV therapeutic vaccine induces the cellular immune system for the removal of infected cells.

The double-blind, controlled, placebo study, which will enroll 36 patients from 6 clinical centers, is designed to assess the safety and tolerance of the vaccine and measure the quality and intensity of the induced immune response.

Cochin-Pasteur Clinical Investigation Center coordinator 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 enroll the first patient before the end of 2012.

"Our early interactions with the French, Belgian and European regulatory agencies facilitated their investigations on our clinical trial applications," Sabbah-Petrover added.

Theravectys chief scientific officer Dr Cecile Bauche said the company believes that it will be able 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 added.

 
 
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