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

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
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.

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 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 Announces Positive Data from Phase I Trial in HPV Infected Women
First ever trial to recruit HPV infected women with no cervical lesions.
Tuesday, April 16, 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
Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
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.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Study Removes Cancer Doubt for Multiple Sclerosis Drug
Researchers from Queen Mary University of London are calling on the medical community to reconsider developing a known drug to treat people with relapsing Multiple sclerosis after new evidence shows it does not increase the risk of cancer as previously thought.
Scroll Up
Scroll Down

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