Date: 2015-10-29
Type of information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Genticel (France)
Product: GTL001 (ProCervix®)
Action
mechanism: therapeutic vaccine/immunotherapy product. GTL001/ProCervix® is an investigational vaccine designed to cure women who are already infected by the HPV16 or HPV18 virus types. It uses the Adenylate Cyclase (CyaA), a protein vector delivering the E7 antigens from HPV 16 and HPV18. The CyaA vector directly targets professional antigen presenting cells. Through its unique delivery mode, CyaA allows the antigen to induce strong CD4+ and CD8+ T cell responses.
Disease: treatment of adult women already infected with human papillomavirus (HPV) genotype 16 or 18
Therapeutic area: Cancer - Oncology - Infectious diseases
Country: USA
Trial details:
Latest
news: * On October 29, 2015, Genticel announced that the first patient of the U.S. phase 1 clinical trial has been vaccinated with GTL001, the Company’s first-in-class therapeutic vaccine candidate against HPV 16/18 infections. This first vaccination follows the FDA clearance last June of Genticel’s Investigational New Drug (IND) application to conduct a phase 1 clinical study of GTL001 in The U.S. phase 1 study is designed to evaluate the tolerability and safety of GTL001 as a therapeutic vaccine in 20 women aged 25 to 65 infected with HPV 16 and/or 18. Three investigational sites will be recruiting these patients during the second half of 2015. \"This trial will provide important insights into the tolerability of GTL001 by enrolling patients over a broader age range than in our European studies,\" stated Sophie Olivier, Chief Medical Officer at Genticel. She continued: “Results from the U.S. phase 1 study, together with those from the fully-recruited phase 2 study in Europe, will serve to design the subsequent clinical development studies for GTL001 in Europe and in the U.S.” Genticel previously obtained encouraging safety, tolerability and immunogenicity results from the European phase 1 study of GTL001 in 47 patients. Based on these results, in 2014 the company initiated a European phase 2 trial to evaluate the efficacy and safety of GTL001 in clearing HPV infection in 239 women aged 25 to 50. All patients were recruited by November 2014. The initial efficacy data from this phase 2 trial will be available in the first half of 2016. Genticel’s follow-on multivalent HPV candidate, GTL002, recently generated positive in vivo proof of concept results for all six oncogenic HPV types targeted and could be tested in a phase 1 trial as early as 2017. With GTL001 and GTL002, Genticel is the first company to establish a staged pipeline of HPV therapeutic vaccines for the millions of women burdened by this unmet medical need.
patients infected with HPV 16 and/or 18, which cause 70% of cervical cancer cases (See below). GTL001 already achieved encouraging results in a phase 1 trial on 47 patients in Europe and the first results of the European phase 2 study on 239 patients will be available in the first half of 2016.
In this U.S. phase 1 trial, Genticel is evaluating GTL001’s safety and tolerance profile in 20 women aged 25 to 65, a subject population that includes women older than those previously studied in Europe. The study is being conducted at 3 investigational sites in the U.S. The company excepts to deliver the trial results during the first half of 2016.
* On June 16th, 2015, Genticel announced that the FDA has cleared Genticel’s Investigational New Drug (IND) application to conduct in the U.S. a phase 1 clinical study of GTL001 (known in Europe as ProCervix®) in patients infected with HPV 16 and/or 18, the two HPV types responsible for 70% of cervical cancer cases. Diane M. Harper, MD, MPH, MS, will lead the U.S. phase 1 study of GTL001 as principal investigator. Dr. Harper is the Gradie and Mary Rowntree Endowed Chair and professor of the department of Family and Geriatric Medicine and Obstetrics and Gynecology at the University of Louisville, KY, and is an internationally recognized researcher, teacher and clinician in the prevention, diagnosis and treatment of HPV-associated diseases.
