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Empresas y finanzas

Active Biotech and Ipsen Announce Completion of Recruitment of Tasquinimod Clinical Phase III Study in Prostate Cancer


    Regulatory News:

    Active Biotech (NASDAQ OMX NORDIC: ACTI) and Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) today announced that the Phase III clinical trial for tasquinimod, a novel compound for the treatment of prostate cancer, is successfully enrolled with over 1,200 randomized patients as planned in the clinical protocol. This achievement triggers a €10 million milestone payment from Ipsen to Active Biotech.

    This study is a global, pivotal, randomized, double-blind, placebo-controlled Phase III clinical trial of tasquinimod in patients with metastatic castrate resistant prostate cancer (mCRPC). The aim of the study is to confirm tasquinimod´s efficacy, with radiological Progression Free Survival (PFS) as primary endpoint and overall survival (OS) as secondary endpoint. The study recruited patients in more than 250 centers all over the word.

    Marc de Garidel, Chairman and Chief Executive Officer of Ipsen, said: "The on-schedule recruitment of tasquinimod phase III clinical trial highlights Active Biotech´s commitment and the growing interest from the medical community for an innovative and differentiated mode of action." Marc de Garidel added: "We now look forward to confirming the encouraging phase II results and bringing a new treatment option to patients with mCRPC."

    "I am very satisfied by the speed of recruitment of prostate cancer patients into this study. We now look forward to the continued development of this global trial and the subsequent development of this unique drug also in other indications", said Tomas Leanderson, President & CEO Active Biotech.

    About tasquinimod

    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 prostate cancer.

    It was announced in December 2009 that the primary endpoint of the Phase II clinical study, 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 Journal of Clinical Oncology in September 2011. The results showed that 6 month progression-free proportions for TASQ and placebo groups were 69% and 37%, respectively (p