Genticel has completed recruitment of patients for its Phase I trial with ProCervix

Toulouse, France, October 19th 2011 - Genticel has completed recruitment of patients for its Phase I trial with ProCervix, its therapeutic vaccine against human papillomavirus (HPV) types 16 and 18 -

Genticel announces that it has completed the recruitment of all patients participating in its phase one clinical trial with a liquid formulation of ProCervix, its candidate therapeutic HPV vaccine designed for adult women already infected with human papillomavirus (HPV) genotype 16 or 18.

The trial takes place at the Centre for the Evaluation of Vaccinations in the Vaccine & Infectious Disease Institute of the University of Antwerp, under the direction of professor Pierre Van Damme. The key objectives are to evaluate the safety and immunogenicity of ProCervix.

In addition, Belgium’s Federal Agency for Medicines and Health Products (FAMHP) has recently also approved Genticel’s request to extend the phase I trial to confirm the safety of a lyophilized formulation of ProCervix.

“We are delighted with the advancement of this important phase I trial that should provide valuable information with regards to safety, local tolerance and immunogenicity,” said Dr Benedikt Timmerman, CEO of Genticel. “Now we have approval for the evaluation of our new lyophilized formulation, Genticel expects to have completed its full Phase I Program in the first half of 2012 and move on to Phase II before the end of the year.”

About ProCervix

This investigational vaccine, called ProCervix, uses the Adenylate Cyclase (CyaA), a protein vector delivering the E7 antigens from HPV16 and HPV18. The CyaA vector directly targets professional antigen presenting cells (APC). Through its unique delivery mode, CyaA allows the antigen to induce strong CD4+ and CD8+ T cell responses. ProCervix is the first HPV vaccine to leverage the CyaA’s mode of action... [PDF] Genticel's Press Release -

BT Pharma changes its name to Genticel and secures EUR 13.1M (USD 17.7M) in capital funding

Toulouse, France, March 9th 2010 -- BT Pharma, a biopharmaceutical company developing innovative immunotherapies to prevent cancers caused by the human papillomavirus (HPV), announces that it has raised 13.1 million Euro in additional funding and changed its name to Genticel. AGF Private Equity led the round, which brought in three new investors, IRDI (Institut Régional de Développement Industriel), Amundi Private Equity Funds and InnoBio fund, managed by CDC Entreprises, within FSI France Investment program. Previous investors, including Edmond de Rothschild Investment Partners (EdRIP), also took part.
To best leverage its unique and broadly applicable therapeutic vaccine platform, Adenylate Cyclase (CyaA), Genticel will focus its efforts on the prevention of cervical cancer in HPV infected women. A phase I clinical trial of Genticel’s lead therapeutic HPV vaccine, ProCervix, is scheduled for the second quarter of 2010. This bivalent product, which carries antigens originating from both HPV16 and HPV18, should offer a curative vaccine solution that will complement current prophylactic vaccines...

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...About Genticel S.A.

Genticel is a bio-pharmaceutical company that started as a spin out of the Institut Pasteur and was called BT Pharma until the 26th of February 2010. The company is currently based in Labège, on the outskirts of Toulouse, France. The company, which employs 21 people, focuses exclusively on the development of immunotherapeutic products aimed at preventing cancers caused by Human Papillomavirus (HPV)... [PDF] Genticel's Press Release - PDF du communiqué de presse de Genticel -