<0> Ipsen initiates a phase II “Switch maintenance” trial in metastatic castrate-resistant prostate cancer with tasquinimod </0>
Regulatory News:
Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the initiation of a new phase II proof of concept clinical trial, evaluating the activity of tasquinimod in advanced metastatic castrate resistant prostate cancer patients. The study aims at establishing the clinical efficacy of tasquinimod used as maintenance therapy in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have not progressed after a first line docetaxel based chemotherapy.
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The “switch maintenance” trial is part of the initial agreement with Active Biotech to enhance tasquinimod’s data package beyond the ongoing phase III placebo-controlled study in men with bone-metastatic CRPC, which has been adequately powered to detect an OS improvement. The phase III study will include about 1,200 patients in more than 250 centers. Recruitment is proceeding according to plan with top line results expected by the end of 2013.
A global, 2:1 randomized, placebo controlled, double-blind Phase II trial investigating up to 1 mg/day of tasquinimod versus placebo in 150 metastatic castrate resistant prostate cancer (mCRPC) patients who have not progressed after a first line docetaxel based chemotherapy. The primary endpoint of the study is radiological progression free survival. The study will be recruited across about 50 centers in Europe.
Tasquinimod has a pleiotropic mode of action which includes immunomodulatory, anti-angiogenic and anti-metastatic activity. Today the development of tasquinimod is principally focused on the treatment of . It was announced in December 2009 that the primary endpoint of the , to show a higher fraction of patients with no disease progression during the six-month period of treatment using tasquinimod, had been met. Phase II results were published in in September 2011. In , overall survival (OS) data was presented at ASCO (American Society of Clinical Oncology).
(NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in or entering pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, tasquinimod for prostate cancer as well as ANYARA for use in cancer targeted therapy, primarily of renal cell cancer. In addition, laquinimod is in Phase II development for Crohn's and Lupus. An additional project in clinical development is the orally administered compound 57-57 for Systemic Sclerosis. Please visit for more information.
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