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

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

Join For Free

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 3,900+ scientific posters on ePosters
  • More than 5,300+ 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 TechnologyNetworks.com 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.

Related Content

Genticel Announces Positive Preclinical Proof of Concept Results of GTL002
Based on Company's versatile Vaxiclase platform.
Tuesday, June 02, 2015
Genticel Completes Procervix Phase II Study Enrollment Ahead of Schedule
A total of 239 subjects infected with HPV 16 and/or 18 enrolled at 39 clinical centers throughout Europe for RHEIA-VAC study of ProCervix.
Saturday, November 15, 2014
Genticel: Business Update - Third Quarter 2014
Net cash and equivalents of €35.2 million as of September 30, 2014.
Tuesday, November 04, 2014
Mary Tanner Appointed to Genticel’s Supervisory Board
Ms. Tanner appointed as independently-acting member and as Audit Committee chairman.
Tuesday, October 07, 2014
Genticel’s Phase II Study with ProCervix Passes the Halfway Mark for Patient Recruitment
The trial is proceeding as planned, after first DSMB (Data and Safety Monitoring Board) review.
Friday, July 18, 2014
Genticel Launches its Phase II Trial in Women Infected with High-Risk HPV
The appointment of Dr. Sophie Olivier as chief medical officer completes the Genticel team to run the Phase II trial across Europe.
Thursday, March 06, 2014
Genticel Appoints New Vice-President
Appointment of Dr Gerald Moeller as vice-president of Company’s supervisory board.
Friday, November 08, 2013
Genticel Secures EUR 18.2 Million (USD 23.7 million) in Capital Funding
Dr. Rainer Strohmenger joins the supervisory board of Genticel.
Friday, April 26, 2013
Genticel Completed Recruitment for its Phase Ib Vaccine Trial in HPV Infected Women
Company expects the final results before the end of the second quarter 2012.
Wednesday, February 22, 2012
Genticel Completes Patient Recruitment for its Phase I Trial with ProCervix
Company expects to complete its full Phase I Program in the first half of 2012.
Thursday, October 20, 2011
Scientific News
First New HIV Vaccine Study for Seven Years Begins
South Africa hosts historic clinical trial of experimental HIV vaccine aiming to safely prevent HIV infection.
Vaccination Against UTIs
Researchers have successfully vaccinated mice against E.coli growth in the bladder and kidneys.
First Steps to Neutralising Zika
Researchers have discovered a highly potent antibody that neutralises Zika infection at a cellular level.
Human Astrovirus Structure Could Lead to Therapies, Vaccines
Study shows where neutralizing antibody binds to human astrovirus, a leading cause of viral diarrhoea in children, elderly, and the immune-compromised.
Fighting Off HIV Infection Closer to Reality
Researchers have made significant progress in the development of a potential vaccine to protect against HIV infection.
Powerful New Tools to Combat Zika
Researchers have created a way to replicate the stucture of Zika virus, removing the genes that make the virus infectious.
More Immunotherapy Options Approved for Lung Cancer
The FDA has approved a new immunotherapy drug for certain patients with non-small cell lung cancer.
Dissecting Bacterial Infections at the Single-Cell Level
Researchers have used single-cell analysis technology to provide new insight into the Salmonella infection process.
Injectable Biologic Therapy Reduces Triglycerides
Study finds first-of-its-kind therapy promising for patients with high triglycerides, cholesterol.
DNA-Based Zika Vaccine Showed Protection From Infection, Brain Damage and Death
The study is the first of its kind to analyze a vaccine in an animal model that is susceptible to the disease, providing information regarding the protective impact of the immune response in susceptible individuals.
Skyscraper Banner

SELECTBIO Market Reports
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
3,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!