The United States Food and Drug Administration (FDA) recently announced that it has cleared a Phase 1 clinical study of GTL001, also called ProCervix, a human papillomavirus (HPV) vaccine made by Genticel, a French biotechnology company and developer of novel immunotherapies designed to prevent HPV cancers.
Genticel previously submitted an Investigational New Drug (IND) application to the FDA to receive permission to begin the study within the U.S.
"This trial will provide important insights into the tolerability of GTL001 by enrolling patients over a broader age range than in our European studies," Sophie Olivier, chief medical officer at Genticel, said. "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."
The study will include HPV patients who are between the ages of 16 and 18 years old who are infected with the two main kinds of HPV that caused approximately 70 percent of all cervical cancer cases.
"This IND clearance represents a significant advance for Genticel, as the upcoming Phase 1 clinical trial for GTL001 will be our first study conducted in the U.S." Gentice CEO Benedikt Timmerman said. "It reinforces our confidence in the strength of our clinical strategy and further demonstrates Genticel's ability to deliver on key aspects of its pipeline development plan."