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Genticel’s Therapeutic Vaccine, Procervix, Aimed At Preventing Cervical Cancer In Patients Already Infected By Human Papillomavirus (HPV), Receives Clearance To Start A Phase I Clinical Trial


7/23/2010 11:21:28 AM

Toulouse, France, July 23, 2010 - Genticel, a biopharmaceutical company developing innovative therapeutic vaccines, announces today that it has obtained approval to start a Phase 1 clinical trial with its candidate therapeutic HPV vaccine on adult women already infected with human papillomavirus (HPV). The clinical trial will take place in Belgium starting Q3 2010.

Belgium’s Federal Agency for Medicines and Health Products (FAMHP), has approved Genticel’s plans as has the ethics committee at Antwerp University. Entry into Phase I marks a significant milestone for Genticel, which completed a EUR 13.1 million fundraising in February 2010.

The trial will take place at the leading international 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, the bivalent therapeutic vaccine developed by Genticel. Preclinical studies of ProCervix demonstrated a fully satisfactory safety profile of this investigational vaccine.

ProCervix is composed of two recombinant Adenylate Cyclase proteins (CyaA) in equal parts. One protein carries the E7 antigen of HPV16 and the other carries the E7 antigen of HPV18. The CyaA vector, the antigen shuttle used in ProCervix, is unique because it directly targets professional antigen presenting cells upon administration to a patient and delivers the antigen so as to trigger immune responses by both CD4+ and CD8+ T lymphocytes.

“Unlike preventive HPV vaccines, which can protect only people who have not yet been infected and are therefore mainly prescribed for young girls, ProCervix is designed for women already infected by the HPV16 or HPV18 virus strains,” said Dr Benedikt Timmerman, CEO at Genticel. “This first clinical trial with ProCervix is an important milestone for Genticel that is in line with plans underpinning the capital increase of 13.1 Million Euro recently achieved by our company.”

About the Human Papillomavirus (HPV) and cervical cancer Recent estimates suggest that approximately 300 million women are carriers of HPV world-wide at any given time. Of these, about 93 million women are infected with HPV 16 and/or HPV18 types, and, of this population, approximately 350,000 patients are diagnosed each year to have cervical cancer.

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 February 26, 2010. The potential of the Adenylate Cyclase vector (CyaA) for vaccines was discovered by researchers at the Institut Pasteur. A licensing agreement is in place allowing Genticel to exploit the technology. The company has previously obtained several preclinical proofs of concept for the use of the CyaA vector in various animal models for oncology, viral and bacterial diseases, illustrating the broad applicability of the CyaA technology. Genticel is currently based in Labège, on the outskirts of Toulouse in France. Genticel’s focus is on the development of immunotherapeutic vaccines preventing cancers caused by Human Papillomavirus (HPV). For more information: http://www.genticel.com

Lynne Chapman ANDREW LLOYD & ASSOCIATES http://www.ala.com lynne@ala.com

Brighton Business Centre 95 Ditchling Road Brighton BN1 4ST ENGLAND Tel: +44 1273 675100 Fax: +44 1273 675400

55 rue Boissonade 75014 Paris FRANCE Tel: +33 1 56 54 07 00 Fax: +33 1 56 54 07 01

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