Active Biotech and Ipsen report for the first time Tasquinimod (TASQ) phase II long term safety data at the 27th European Association of Urology (EAU) Congress
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 publically 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 concern were identified.
The development of TASQ is principally focused on the treatment of prostate cancer. Studies have concluded that TASQ exhibits immunomodulatory, anti-angiogenic and anti-metastatic activity. 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 TASQ, had been met. Final Phase II results were published in Journal of Clinical Oncology in September 2011. It was concluded that TASQ significantly slowed disease progression and improved Progression Free Survival (PFS) in patients with metastatic castrate-resistant prostate cancer (CRPC), alongside an acceptable side effect profile. Six month progression free proportion of patients for TASQ and placebo treatment groups were 69% and 37%, respectively (p<0.0001), with a median PFS of 7.6 vs. 3.3 months (p=0.0042).
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC:ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, TASQ for prostate cancer and 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. Further projects in clinical development comprise the two orally administered compounds, 57- 57 for Systemic Sclerosis as well as RhuDexTM for RA. Please visit www.activebiotech.com for more information.
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The information was submitted for publication at 08:30 a.m. CET on February 24, 2012.
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.1 billion in 2011. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by four franchises: neurology / Dysport®, endocrinology / Somatuline®, uro-oncology / Decapeptyl® and hemophilia. Moreover, the Group has an active policy of partnerships. R&D is focused on innovative and differentiated technological patient-driven platforms, peptides and toxins. In 2010, R&D expenditure totaled more than €220 million, above 20% of Group sales. The Group has total worldwide staff of close to 4,500 employees. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
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