PARIS--()--THERAVECTYS, a French biotechnology company currently developing a new generation of vaccines, today announced it was granted authorization by the National Security Agency for Medicines and Health Products in France (Agence Nationale de Sécurité du Médicament et des produits de santé) and the Federal Agency for Medicines and Health Products in Belgium (Agence Fédérale des Médicaments et des Produits de Santé) to launch a phase I/II clinical trial for its anti-HIV therapeutic vaccine candidate based on lentiviral vector technology.
“We expect to enroll our first patient before the end of the year”
Renaud VAILLANT, Chief Executive Officer of THERAVECTYS states “This authorization marks a key step in the company's development. THERAVECTYS will be the first company in the world to initiate an anti-HIV therapeutic vaccination clinical trial with lentiviral vectors."
About the trial sponsored by THERAVECTYS
This double-blind
placebo controlled study will include 36 patients in 6 clinical centers:
4 in France and 2 in Belgium.
Pr. Odile LAUNAY, coordinator
at the Cochin-Pasteur Clinical Investigation Center based at the Cochin
Hospital in Paris, France, will be the coordinating investigator of the
trial. “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” says Pr. Odile LAUNAY.
A phase I/II clinical trial
With this first human trial, THERAVECTYS
not only intends to evaluate the safety and tolerance of its therapeutic
vaccine candidate but also to measure the quality and intensity of the
induced immune response.
The anti-HIV therapeutic vaccine developed
by THERAVECTYS should allow patients treated with antiretroviral
drugs to stop taking them on a sustainable and perhaps permanent basis
once vaccinated. “We expect to enroll our first patient before the
end of the year”, says Dr. Emmanuelle SABBAH-PETROVER,
in charge of THERAVECTYS’ Regulatory Affairs and Clinical Trials who
adds: “Our early interactions with the French, Belgian and European
regulatory agencies facilitated their investigations on our clinical
trial applications.”
Lentiviral vectors supporting anti-HIV vaccination
THERAVECTYS
uses lentiviral vector technology to develop a new generation of
vaccines. Unlike other gene transfer vectors, lentiviral vectors have
the unique ability to induce a strong, sustainable and diversified
cellular immune response, which should help remove infected cells.
Dr. Cécile BAUCHE, Chief Scientific Officer of THERAVECTYS states: “In 12 months, THERAVECTYS should be able to demonstrate safety and immunogenicity in humans. This expected confirmation will not only bring tremendous hope for all HIV positive patients, but it will also open a path for new developments.”
About THERAVECTYS:
THERAVECTYS, a biotechnology
company, has developed a new generation of vaccines based on lentiviral
vector technology. Built on the result of fundamental research conducted
at the Pasteur Institute, this breakthrough technology is expected to
enable the prevention or effective treatment of many diseases in which
the induction of effective cellular immune response is required: viral
diseases (HIV), bacterial or parasitic diseases, cancers, etc. Since its
creation, THERAVECTYS has been working on the development of a
therapeutic vaccine against HIV, for which the Phase I/II clinical trial
has just been initiated. Benefitting from an exclusive worldwide license
with the Pasteur Institute and from financial support from public
institutions (OSEO, ANR), THERAVECTYS is continuing its research
and development efforts to combat other diseases. It plans to be
developing new vaccine candidates shortly, either alone or in
collaboration with other pharmaceutical laboratories.
More information can be found at www.theravectys.com
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