Active Biotech and Ipsen to present Tasquinimod Phase II Overall Survival data at the 2012 ASCO Annual Meeting
Lund (Sweden) and Paris (France), May 18, 2012, Active Biotech (NASDAQ OMX NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) will present tasquinimod (TASQ), their prostate cancer drug candidate, at the scientific conference "2012 ASCO Annual Meeting" to be held in Chicago (USA) on 1-5June 2012. The presentation will provide overall survival (OS) data from the tasquinimod Phase II study in chemotherapy-naïve metastatic castrate resistant prostate cancer (CRPC).
The poster "Tasquinimod and survival in men with metastatic castration-resistant prostate cancer: Results of long-term follow-up of a randomized phase II placebo-controlled trial" A.J. Armstrong, M. Häggman, W.M. Stadler, J.R. Gingrich, V.J. Assikis, J. Polikoff, S.R. Denmeade, D. J. George, C. Andreou, W.R. Clark, P. Sieber, R. Agajanian, L. Belkoff, J-E. Damber, Ö. Nordle, G. Forsberg, M. A. Carducci, R. Pili. will be presented on June 4 at 08:00 am CDT (3:00 pm CET).
The abstract released today, based on 97 events, shows that overall survival after tasquinimod treatment is longer than previously reported in this patient population. Median time to death was 34.2 vs. 30.2 months (tasquinimod vs placebo). A preliminary subgroup analysis using the PCWG2 (Prostate Cancer Clinical Trials Working Group 2) defined criteria showed that median time to death in the bone-metastatic subgroup was 34.2 vs. 25.6 months (tasquinimod vs placebo). The impact of the cross-over design and the imbalance among groups in favor of placebo will be discussed in the presentation.
For more detailed information, please see www.asco.org.
A global, pivotal, randomized, double-blind, placebo-controlled Phase III study of tasquinimod in patients with metastatic CRPC is ongoing. The aim of the study is to confirm tasquinimod's efficacy on the disease, with radiological Progression Free Survival (PFS) as the primary endpoint and overall survival as secondary endpoint. The study will include about 1,200 patients in more than 250 clinics. Recruitment is proceeding according to plan with top line results expected by the end of 2013.
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. It was concluded that tasquinimod significantly slowed disease progression and improved Progression Free Survival (PFS) in chemonaïve patients with metastatic castrate-resistant prostate cancer (CRPC), alongside an acceptable side effect profile. Six month progression free proportion of patients for tasquinimod 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). Analysis of up to three years safety data from the Phase II study, presented at the EAU February 2012, show that 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.
Active Biotech AB (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. Further projects in clinical development comprise the two orally administered compounds, 57-57 for Systemic Sclerosis and RhuDex® for rheumatoid arthritis. Please visit http://www.activebiotech.com for more information.
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 2011, R&D expenditure totaled more than 250 million, above 21% 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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For further information:
Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: +46 46 19 20 00
Fax: +46 46 19 11 00
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Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act. This information was provided to the media for publication 08:30 a.m. CET on May 18, 2012.
Active Biotech and Ipsen to present Tasquinimod Phase II OS data