Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

Genticel Announces Positive Data from Phase I Trial in HPV Infected Women

Published: Tuesday, April 16, 2013
Last Updated: Tuesday, April 16, 2013
Bookmark and Share
First ever trial to recruit HPV infected women with no cervical lesions.

Genticel has announced positive safety and immunogenicity data obtained in the phase I study with its lead product ProCervix, a vaccine designed to induce a curative cellular immune response in patients infected with HPV16 and/or HPV18.

These high-risk human papillomavirus (HPV) types are responsible for respectively 50 per cent and 20 per cent of cervical cancer world-wide.

ProCervix is targeted at women who are already infected by the HPV16 and/or HPV18 virus types before high grade lesions or cancer occurs. It is the first vaccine to address the medical need of this high risk population as the preventive HPV vaccines are aimed at protecting people who are not infected.

The clinical trial is conducted at the Centre for the Evaluation of Vaccinations in the Vaccine and Infectious Disease Institute of the University of Antwerp, Belgium. The study is directed by Professor Pierre Van Damme.

The key objectives of the trial are to evaluate the safety and immunogenicity of ProCervix in combination with a commercially available product as adjuvant. The trial includes ascending dose cohorts as well as a placebo-controlled, double-blind, randomized extension.

The data indicate that ProCervix plus adjuvant shows good safety and local tolerance at the highest dose evaluated. HPV-E7- antigen specific T cell responses have been detected in a majority of vaccinated women. Moreover, viral clearance is several-fold higher in the group of patients treated with ProCervix than in the placebo group.

“This Phase I trial with ProCervix has met both its primary objective (safety and local tolerance) and secondary objective (antigen-specific cellular immunity),” said Dr. Benedikt Timmerman, chief executive officer of Genticel. “In addition, the results available suggest that ProCervix with adjuvant is clearing the virus in HPV16- or HPV18- infected women.”

“This trial is the first ever to recruit HPV infected women with no cervical lesions; ProCervix may become the first product that actually closes the gap between preventive vaccines and later stage therapeutic options,” said Dr Marie-Christine Bissery, chief scientific officer of Genticel.

Dr Bissery continued, “Additional longer-term clinical data is being collected, including viral clearance in women vaccinated with a reconstituted lyophilized form of ProCervix.”

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Scientific News
Genetic Basis of Fatal Flu Side Effect Discovered
A group of people with fatal H1N1 flu died after their viral infections triggered a deadly hyperinflammatory disorder in susceptible individuals with gene mutations linked to the overactive immune response, according to a recent study.
Developing Drug Resistance may be a Matter of Diversity for Tuberculosis
Researchers have probed the bacteria that causes tuberculosis, Mycobacterium tuberculosis, to learn more about how individual bacterial cells change and adapt while in the human body.
Surprising Trait Found in Anti-HIV Antibodies
Scientists at The Scripps Research Institute (TSRI) have new weapons in the fight against HIV.
Some Gut Microbes May Be Keystones of Health
University of Oregon scientists have found that strength in numbers doesn’t hold true for microbes in the intestines. A minority population of the right type might hold the key to regulating good health.
Essential Component of Antiviral Defense Identified
Infectious disease researchers at the University of Georgia have identified a signaling protein critical for host defense against influenza infection.
Single Vaccine for Chikungunya, Related Viruses May be Possible
What if a single vaccine could protect people from infection by many different viruses? That concept is a step closer to reality.
Is Allergy the Price We Pay for Our Immunity to Parasites?
New findings help demonstrate the evolutionary basis for allergy.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
Mucus – the First Line of Defence
Researchers reveal the important role of mucus in building a good defence against invaders.
Antibody Targets Key Cancer Marker
University of Wisconsin-Madison researchers have created a molecular structure that attaches to a molecule on highly aggressive brain cancer and causes tumors to light up in a scanning machine.

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos