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news.French biotechnology firm Genticel has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to conduct a US Phase I trial of GTL001 in patients infected with human papillomavirus (HPV) 16 and/or 18.
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Both these HPV types are responsible for 70% of cervical cancer cases and currently there are no treatment options available for the 93 million women worldwide infected with these cancers.
University of Louisville professor of the department of Family and Geriatric Medicine and Obstetrics and Gynecology DianeHarper will lead the US phase I trial of GTL001 as principal investigator.
The Phase I trial is designed to evaluate the tolerability and safety of GTL001 as a therapeutic vaccine in 20 women aged 25 to 65 years infected with HPV 16 and/or 18.
The company said that three investigational sites will be enrolling these patients during the second half of this year. GTL001 is known in Europe as ProCervix.
Genticel chief medical officer Dr Sophie Olivier said: "This trial will provide important insights into the tolerability of GTL001 by enrolling patients over a broader age range than in our European studies.
"Results from the US Phase I study, together with those from the fully-recruited Phase II study in Europe, will serve to design the subsequent clinical development studies for GTL001 in Europe and in the US."
Earlier, the company had secured encouraging safety, tolerability and immunogenicity results from the European phase I trial of GTL001 in 47 patients.
Based on these results, the company has started a European Phase II trial last year to evaluate the efficacy and safety of GTL001 in clearing HPV infection in 239 women aged 25 to 50. The initial efficacy data from this phase II trial will be made available in the first half of next year.