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news.Genticel has confirmed the ability to use widely available genotyping HPV tests in the planned phase 3 program of GTL001, the company's most advanced therapeutic vaccine candidate against HPV 16/18 infections.
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The Company also reports that GTL001 drug product has completed stability assays demonstrating a five-year shelf life.
As announced on January 7, 2016, Genticel evaluated Roche Molecular Systems’ cobas 4800 test, commercially available both in Europe and in the US, in order to confirm whether the globally validated cobas HPV Test could be used for the recruitment and post-treatment analysis of patients in the planned Phase 3 program of GTL001. This evaluation was conducted by assessing existing samples from the Phase 2 trial at the clinical virology threshold planned in the global phase 3 program of GTL001.
The results obtained with the cobas® HPV test, which has undergone extensive clinical validation worldwide, were equivalent to those generated with the clinical laboratory test used per protocol in the Phase 2 trial on the same samples.
"The ability to use a clinically validated and globally available test such as the cobas HPV test and the demonstration of GTL001 five-year stability were two critical milestones towards partnering and registration studies for GTL001," said Benedikt Timmerman, PhD., MBA, and Chief Executive Officer of Genticel.
"We are very pleased with these achievements and continue to move forward with preparations for the GTL001 Phase 3 program."
GTL001 is currently being evaluated in a randomized, double-blind phase 2 efficacy study in Western Europe in HPV 16/18 positive patients with normal cytology (NILM), borderline (ASCUS) or with low -grade lesions (LSIL).
Virology results at 12 months were reported earlier this year1, with encouraging results in the study subpopulation of women who have not yet developed cellular lesions.
This subpopulation represents over 80% of HPV 16/18 positive women, the target population of GTL001. In this phase 2 study, Genticel is using, per protocol, the ISO15189 certified qPCR test from AML (Antwerp, Belgium), a full genotyping test that is used in the Flemish population-based cervical cancer screening program. However, this laboratory-developed test is only performed in Belgium.