• ProCervix Phase II study: more than 50 per cent of patients already enrolled
• DSMB (Data and Safety Monitoring Board) endorses the unchanged continuation of the clinical trial
• Five patents granted since the beginning of 2014 further enhance protection of Genticel’s pipeline products ProCervix and Multivalent HPV
Genticel (Euronext Paris and Brussels: FR0011790542 - GTCL), a French biotechnology company and a leading developer of therapeutic vaccines, today announces its participation in the Rodman and Renshaw investor conference in New York, September 8-10.
Benedikt Timmerman, the founder and CEO of Genticel will introduce the company. He will highlight recent progress made with ProCervix, a ‘first-in-class’ therapeutic vaccine currently in Phase II in Europe. ProCervix is designed to provide a therapeutic solution for women with highly oncogenic strains of human papillomavirus (HPV) before high-grade lesions or cancer occur.
In line with its stated objectives, Genticel has already recruited over half of the targeted number of patients for the phase II RHEIA-VAC efficacy trial of ProCervix. This once again demonstrates the company's ability to fulfill its commitments. Moreover, the DSMB unanimously recommended continuation of the trial without modification.
The Phase II launch follows promising results from the Phase I trial conducted at the Vaccine and Infectious Disease Institute of the University of Antwerp (Belgium), under the direction of Professor Pierre Van Damme. The results showed that ProCervix has a satisfactory safety, local tolerance, immunogenicity profile and suggested efficacy in totally eradicating HPV viral infection.
The ongoing multicenter Phase II trial will evaluate ProCervix' efficacy in terms of viral clearance. It received a favorable scientific opinion from the European Medicines Agency (EMA).
Since ProCervix is currently the only clinical stage therapeutic vaccine positioned on this broad target population with no satisfactory therapeutic solution, Genticel believes that it has true blockbuster potential. A market access study indicated that it could potentially be prescribed to 1.3 million women annually with potential peak annual sales of over EUR 1 billion (USD 1.29 billion).
The intellectual property protection of Genticel’s pipeline candidates was also further enhanced in 2014 with five important patents being granted: US 8628779, US 8637039, IN 258906 and KR 10-1382250, granted respectively in the USA, India and South Korea. They reinforce the protection covering ProCervix and a follow-on therapeutic candidate ‘Multivalent HPV’. JP 5496669, granted in Japan protects compounds such as ProCervix and related immune-therapeutics in combination with immunosuppressive medicines for use in advance disease indications such as cervical carcinoma and HPV-associated anal and oropharyngeal cancers.
Benedikt Timmerman said: “The Rodman and Renshaw investor conference is an excellent opportunity for Genticel to present our candidate therapeutic vaccines to US investors. We will share our contribution to the fight against HPV-induced cancers and elaborate on our business strategy and growth perspectives.”
Genticel also plans to participate in various other healthcare investor events over the coming months:
European Midcap Event (Paris) - October 2 and 3, 2014
KBC Healthcare Investor Event (New York) - November 13, 2014
JP Morgan Healthcare Conference (San Francisco) - January 12 and 15, 2015
Financial calendar (after Euronext stock exchange closing):
H1 results 2014 - September 25, 2014
For more information about Genticel’s participation in the conference, please contact Donna Williamson at meetings@rodm.com or log-in to the partnering session for 1x1 Requests on the dedicated web site http://www.rodman.com
More information about Genticel is available at: http://www.genticel.com
About ProCervix
ProCervix is 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 a potential blockbuster that, at peak, could be prescribed to about 1.3 million women per year and lead to sales of more than EUR 1 billion.
About Genticel
Genticel is a French biopharmaceutical company specialized in the development of therapeutic vaccines aimed at eliminating, at an early stage, the human papillomavirus (HPV) responsible for cervical cancer. Besides ProCervix, a second therapeutic vaccine candidate called ‘Multivalent HPV’ targets six of the most pertinent strains of HPV and is currently in preclinical stage. Vaxiclase, the technology platform used in this product is ideally adapted for developing early-intervention immunotherapies against multiple infectious or cancerous diseases.
Genticel is based in Paris and Toulouse and was awarded the 2013 Innovation Prize by the ‘Grands Prix de l’Economie’.
Since April 4, 2014, Genticel shares have been listed on the regulated Euronext markets in Paris and Brussels.
To view the original release: http://www.ala.com/article.php?id=447
Mark Tidmarsh
mark@ala.com
ANDREW LLOYD & ASSOCIATES
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