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Genticel to Evaluate Roche HPV Test for Phase III Therapeutic Vaccine Trial

NEW YORK (GenomeWeb) – Genticel announced today that it has reached an agreement with Roche Molecular Systems to evaluate the latter's Cobas HPV test prior to a planned Phase III clinical trial of a therapeutic vaccine for HPV patients. Terms of the agreement were not disclosed.

The French biotechnology firm is evaluating the use of the Cobas test to assess HPV status before and after treatment with GTL001, a therapeutic vaccine consisting of two adenylate cyclase vectors carrying the E7 oncoprotein antigens responsible for cell transformation in HPV 16 and HPV 18. Unlike prophylactic vaccines which inoculate a patient prior to infection, therapeutic vaccines fight infection once it is already present by activating the T-cell immune response.

Genticel is currently undertaking a Phase II trial in seven Western European countries with a cohort of 236 HPV 16/18 positive patients who have normal cervical cytology or minor abnormalities. Vaccination consisted of two injections six weeks apart, plus application of a cream-like adjuvant at the injection site immediately following injection and reapplied the next day. Results of the trial are expected in the first half of 2016.

The current trial uses a ISO15189 certified qPCR test from Belgian firm AML, which is a lab-developed genotyping test that can only be performed in Belgium, the firm noted in a statement. Genticel will now test existing samples from Phase II with the Cobas HPV test at the threshold being considered for the global Phase III trail.

"The ability to evaluate the Cobas HPV test is an important milestone that will help us anticipate requirements for the planned Phase III program of GTL001 and identify the patient population that will most benefit from treatment," Genticel CEO Benedikt Timmerman said in the statement.

The Cobas HPV test is approved in the US for primary cervical cancer screening in lieu of a Pap test and was selected as the first line screening test in the National Cervical Cancer Screening Program in the Netherlands. To date there is no treatment available for patients with a positive HPV test result and normal cytology, although most clear the infection within two years.