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news.Oncolytics Biotech has reported positive preliminary results from a US Phase II clinical trial evaluating intravenous administration of Reolysin in combination with gemcitabine (Gemzar) as a treatment for patients with advanced pancreatic cancer.
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The single arm, open-label, Phase II study is designed to enroll patients with advanced or metastatic pancreatic adenocarcinoma with measurable disease who have not received any prior chemotherapy or biotherapy.
The trial expects to enroll 17 evaluable patients in the first stage, and if three or more patients received clinical benefit, the study would then proceed to the next stage.
This endpoint was achieved after six evaluable patients were enrolled, and all the patients treated reported symptomatic improvement.
The study’s primary objective is to establish the clinical benefit rate (complete response + partial response + stable disease) of Reolysin in combination with gemcitabine in patients with advanced pancreatic cancer.
The secondary objectives are to establish progression-free survival, and the safety and tolerability of Reolysin in combination with gemcitabine.
Oncolytics Biotech is planning to complete enrolment in the first stage of the study and then continue with further studies.