Tasquinimod Biomarker Phase II data presented at ESMO 2012



    Regulatory News:

    Active Biotech (NASDAQ OMX NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) have presented a new set of data on biomarkers from the previously concluded tasquinimod Phase II study in chemotherapy-naïve metastatic castrate resistant prostate cancer (CRPC) at the scientific congress ESMO (European Society for Medical Oncology) held in Vienna September 28-October 2.

    Dr Michael Carducci, Johns Hopkins Medical Institute, Baltimore, US, presented on Saturday September 29 the poster "Tasquinimod mechanism of action biomarkers: Correlation with PFS and survival in men with metastatic castrate resistant prostate cancer treated in a randomized phase 2 trial*".

    The purpose of this analysis from the phase II trial was to investigate the effects of tasquinimod on selected biomarkers to confirm preclinical findings on the mechanism of action. The results support an effect of tasquinimod on both immunomodulation and angiogenesis which positions tasquinimod as a potentially unique therapeutic approach with a mechanism of action that does not target the androgen receptor pathway.

    The findings shall be further validated in the ongoing phase III placebo-controlled study in men with bone-metastatic CRPC, which has been adequately powered to detect an OS improvement .

    For more detailed information, please see www.esmo.org. The presentation is available on Active Biotech´s web site www.activebiotech.com.

    * M.A. Carducci, A.J. Armstrong, M. Häggman, W.M. Stadler, J.R. Gingrich, V. Assikis, J. A. Olsson, Ö. Nordle, G. Forsberg, R. Pili.

    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.

    About tasquinimod phase II

    A global clinical trial 2:1 randomized, placebo controlled, double-blind Phase II trial investigating up to 1 mg/day of TASQ versus placebo in 206 asymptomatic patients with metastatic castrate resistant prostate cancer (CRPC). The primary endpoint defined as proportion of patients with disease progression at six months, was reached. The results showed that 6 month progression-free proportions for TASQ and placebo groups were 69% and 37%, respectively (p