Teva launches prostate cancer Phase III study

Teva and OncoGenex are responsible for the drug's development and commercialization.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported the initiation of Synergy, a global Phase III trial evaluating custirsen as first line therapy for the treatment of castrate-resistant prostate cancer.

The clinical trial will be conducted in approximately 125 cancer centers and with designated recruitment of 800 men with metastatic CRPC who have disease progression and require first-line docetaxel/prednisone chemotherapy. Patients will be randomized to receive treatment with either docetaxel/prednisone plus custirsen or with docetaxel/prednisone alone. The main goal of the study is to see if overall survival is longer in patients receiving custirsen.

The current study is the second of three planned by the two companies.

Co-principal investigator Dr. Johann de Bono said, "The prostate cancer landscape is rapidly evolving with the introduction of new therapies to improve patient outcomes. If validated in these two Phase 3 trials, custirsen could offer a unique benefit to patients for prolonged survival and improved quality of life, both of which are key considerations in the treatment of the disease." Dr. de Bono is affiliated with Institute of Cancer Research and The Royal Marsden Hospital, London.

Custirsen has received Fast Track designation from the US Food and Drug Administration (FDA).

Custirsen utilizes second-generation antisense technology, licensed from Isis Pharmaceuticals, to target and inhibit production of clusterin, a protein involved in resistance of cancer tumors to treatments. OncoGenex and Isis partnered in the discovery of custirsen. Teva and OncoGenex are responsible for the drug's development and commercialization.

Shares in Teva rose 1.46% on Friday, giving a market cap of $48.06 billion. On the Tel Aviv Stock Exchange (TASE) today, Teva shares are down 1.11%.

Published by Globes [online], Israel business news - www.globes-online.com - on October 3, 2010

© Copyright of Globes Publisher Itonut (1983) Ltd. 2010

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