Active Biotech's (NASDAQ OMX NORDIC: ACTI) and Ipsen's (Paris:IPN) (Euronext: IPN; ADR: IPSEY) castrate resistant prostate cancer project, TASQ, will be presented at the 27th Annual EAU Congress held in Paris on 24-28 February 2012. The presentation will detail the analysis of up to three years safety data from the TASQ Phase II study in chemotherapy-naïve metastatic castrate resistant prostate cancer (CRPC).
The poster "Long term safety and efficacy in a randomized multicenter international phase II study of tasquinimod in chemotherapy-naïve patients with metastatic castrate resistant prostate cancer" A.J. Armstrong, J.R. Gingrich, M. Häggman, W.M. Stadler, J.E. Damber, L. Belkoff, R. Clark, S. Brosman, O. Nordle, G. Forsberg, M.A. Carducci, R. Pili. will be presented on February 25 at 2:15 pm CET. The poster will combine the long term safety data and the already published encouraging efficacy data, published in the Journal of Clinical Oncology (JCO) in September 2011. The poster will be publicly available after the presentation on www.activebiotech.com.
Treatment side effects were mild to moderate (~ 5% of AEs grade 3-4), manageable and less frequent after two months of therapy. The adverse events observed included gastrointestinal disorders, primarily observed initially during treatment, fatigue and musculoskeletal pain.
Andrew J. Armstrong, Associate Professor of Medicine and Surgery and Medical Oncologist at Duke University, tasquinimod Phase II investigator, said: "These long term safety data are of critical importance as tasquinimod is being evaluated in elderly men with castrate resistant prostate cancer, and standard treatment of these patients will include a sequence of active therapies used for long periods of time. These new data show that tasquinimod long term safety is acceptable. Tasquinimod may therefore be a suitable therapy to evaluate at an early stage in management of CRPC, either as monotherapy or in combination with other effective agents for prostate cancer, as it does not jeopardize the patient's chances to receive additional treatment".
A global, pivotal, randomized, double-blind, placebo-controlled Phase III study of TASQ in patients with metastatic CRPC is ongoing. The aim of the study is to confirm TASQ's effect on the disease, with radiological PFS as the primary endpoint and overall survival as secondary endpoint. The study will include about 1,200 patients in more than 250 clinics.
The independent Data and Safety Monitoring Board (DSMB) overseeing the ongoing Phase III clinical trial has recommended the study to proceed as per protocol as no safety concerns were identified.
Source: Active Biotech
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