New data to be presented at the 2013 ASCO Annual Meeting show Active Biotech's commitment to oncology research - Seite 2

- (P2622) A Phase II, multicenter, open-label, proof of concept study of tasquinimod in patients with advanced/metastatic hepatocellular (HCC), ovarian (OC), renal cell (RCC) and gastric (GC) carcinomas. B Escudier, S Faivre, A Oza, E Van Cutsem, A Geniaux, F Baton. This Phase II, multinational, exploratory proof of concept study performed and sponsored by Ipsen, will evaluate tasquinimod activity in four independent cohorts of patients (HCC, OC, RCC and GC) with progressive disease after standard therapy. An innovative design based on the proportion of patients who have not progressed nor died at predefined time points (PFS rate) will be used in each cohort independently.

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 asymptomatic to mildly symptomatic metastatic CRPC who have not yet received chemotherapy is ongoing. 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 key secondary endpoint. The study recruited 1, 245 patients in 37 countries covering more than 200 centers. 

Notes to editors

About ANYARA
ANYARA is a TTS (Tumor Targeted Superantigen) compound that makes the treatment of cancer tumor-specific. The development of ANYARA is mainly focused on renal cell cancer.
In January 2013, the initial results were presented from the ANYARA Phase II/III clinical study. The study encompassed 513 patients and was designed to evaluate the effect of ANYARA in combination with interferon-alpha, compared with interferon-alpha alone, in patients with advanced renal cell cancer. The primary endpoint was overall survival (OS).
The results showed that the ANYARA Phase II/III study did not achieve its primary endpoint to show a prolonged OS in the ITT population. A subgroup analysis, comprising about 25 percent of the patients with low/normal levels of base line IL-6 and expected anti-superantigen antibody levels, showed a statistically significant treatment advantage on both OS (p=0.02, HR=0.59) and progression-free survival (PFS). In North America and Western Europe, this subgroup accounts for approximately 40-50% of the total number of advanced renal cell cancer patients. The safety profile was favorable and in line with that observed earlier. Active Biotech plans to continue the development of ANYARA jointly with a partner after completed analysis of study data and discussions with relevant authorities.