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GTL001, placebo roughly equal in HPV study
August 2016
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PARIS & TOULOUSE, France—Interim results of Genticel's Phase 2 trial of GTL001, its HPV16/18 immunotherapeutic candidate, have been released at 18 months. Per the analysis, no new unexpected safety events were noted and viral clearance in the treated total population or the subgroups did not differ statistically from natural clearance in the placebo group. This is similar to the results seen at 12 months, which reported no difference in viral clearance between treatment and placebo overall, though there was a trend toward significant difference in subgroup analyses, notably in the NILM1 group.
 
Results concerning secondary endpoints for the study, including the difference in progression to high-grade lesions or cancer between treatment and placebo, are expected in Q1 2017, after the final analysis at 24 months.
 
Dr. Benedikt Timmerman, CEO of Genticel, noted that, “These results did not meet our expectations, and GTL001 development plan is being reviewed accordingly.”

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