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

Genticel Launches its Phase II Trial in Women Infected with High-Risk HPV

Published: Thursday, March 06, 2014
Last Updated: Thursday, March 06, 2014
Bookmark and Share
The appointment of Dr. Sophie Olivier as chief medical officer completes the Genticel team to run the Phase II trial across Europe.

Genticel has announced that it has started a phase II study with its lead product ProCervix, a therapeutic vaccine designed to induce a curative cellular immune response in patients infected with HPV16 and/or HPV18. The high-risk human papillomavirus HPV16 and/or HPV18 types are responsible for 70 per cent of cervical cancers worldwide.

ProCervix is targeted at women already infected by the HPV16 and/or HPV18 viruses before high-grade lesions or cancer occur. It is the first therapeutic vaccine to address the medical need of this high-risk population, because the preventive HPV vaccines are only effective in people who are not yet infected.

The Phase I study was conducted at the Vaccine and Infectious Disease Institute of the University of Antwerp, Belgium under the direction of Professor Pierre Van Damme. The results indicated that ProCervix has a satisfactory safety, local tolerance and immunogenicity profile.

This study revealed the dose and vaccination regime required for further development. The clearance of HPV virus and maintenance of virus-free status was also markedly higher in the patients treated with ProCervix versus those in the placebo group.

Based on these promising results with ProCervix, endorsed by an international group of experts, Genticel has initiated a randomized, placebo-controlled efficacy Phase II trial. This multi-centric trial has received favorable scientific advice from the European Medical Agency (EMA) and runs across several European countries.

Dr. Sophie Olivier appointed as chief medical officer
Genticel has recruited Dr. Sophie Olivier as chief medical officer to lead the clinical development of its pipeline, in particular the ProCervix phase II trial. Dr. Olivier has over 20 years of experience in gynecology, women’s health and regulatory affairs.

Dr. Sophie Olivier was scientific administrator at the European Medicines Agency (EMA) in London, UK. She was responsible for assessing Pediatric Investigational Plans, in particular vaccines. Prior to EMA, Dr. Olivier also worked for 15 years with Wyeth.

As a senior director, Women’s Health and Bone Repair, she was responsible for designing and implementing international clinical development programs in women’s health, leading to FDA and European submissions.

Dr. Olivier is an MD from Aix-Marseille University. She also holds a Master’s degree in Reproductive Biology and a Science and Statistics Masters from Pierre and Marie Curie University - Paris VI.

“We are very pleased to welcome Dr. Olivier. Her expertise in drug development, especially in vaccines and gynecology, and her experience at the EMA are considerable assets for Genticel, in particular for the ProCervix Phase II trial,” said Benedikt Timmerman, CEO of Genticel. “ProCervix is a first-in-class therapeutic HPV vaccine aimed at treating HPV infected women for whom no therapeutic options currently exist and with only ‘watchful waiting’ as an alternative.”

“I am thrilled to join the team at Genticel and to work on the development of these promising therapeutic vaccines,” said Dr. Olivier. “The phase I for the therapeutic candidate vaccine was successful and I look forward to pursuing its development in Europe and abroad.”


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 3,200+ scientific posters on ePosters
  • More than 4,700+ 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 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
Scientific News
Assessing the Effectiveness of Genome-Editing Technologies
Researchers have developed a cost-effective and rapid method for assessing edits generated by CRISPR-Cas9 and other genome-editing technologies.
New Cancer Drug Target Found in Dual-Function Protein
Findings from a study from TSRI have shown that targeting a protein called GlyRS might help to halt cancer growth.
Alzheimer's Genetics Point To New Research Direction
A University of Adelaide analysis of genetic mutations which cause early-onset Alzheimer’s disease suggests a new focus for research into the causes of the disease.
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Fix for 3-Billion-Year-Old Genetic Error
Researchers at The University of Texas at Austin have developed a fix that allows RNA to accurately proofread for the first time.
Higher Frequency of Huntington's Disease Mutations Discovered
University of Aberdeen study shows that the gene change that causes Huntington's disease is much more common than previously thought.
Revealing the Genetic Causes of Bowel Cancer
A landmark study has given the most detailed picture yet of the genetics of bowel cancer — the UK's fourth most common cancer.
The Epigenetic Influences of Chronic Pain
Researchers at Drexel University College of Medicine are aiming to identify new molecular mechanisms involved in pain.
Fighting Resistant Blood Cancer Cells
Biologists present new findings on chronic myeloid leukemia and possible therapeutic approaches.
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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!