Active Biotech AB: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
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Provider: MarketLine (a Datamonitor Company)
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Active Biotech AB Announces Results from Phase II/III ANYARA Trial For Treatment Of Renal Cell Cancer
Active Biotech AB announced initial results from the ANYARA Phase II/III clinical study. The study encompassed 513 patients and was designed to evaluate 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 ANYARA Phase II/III study did not achieve primary endpoint to show a prolonged OS in ITT population. Unexpectedly, and in contrast to previous studies in other territories, a majority of patients in the current study had high levels of pre-formed antibodies against superantigen component of ANYARA. A subgroup analysis, excluding patients with high levels of pre-formed antibodies, resulted in a trend for survival benefit with ANYARA treatment. Furthermore, baseline levels of the biomarker IL-6 was shown to be an important predictive marker for a positive treatment effect of ANYARA. In a hypothesis generating subgroup analysis, 25% of patients with low/normal levels of base line IL-6 and expected anti-superantigen antibody levels, showed a statisticall treatment advantage on both OS (p=0.02, HR=0.59) and PFS. In North America and Western Europe, this subgroup account for 40-50% of the total number of advanced renal cell cancer patients. The safety profile was good and in line with previous observations; the common adverse events associated with ANYARA treatment were grade 1-2 fever, nausea or vomiting.
Latest Developments for Active Biotech AB
- Active Biotech AB and Teva Pharmaceutical Industries Ltd Announce Post-Hoc Analyses of Phase III ALLEGRO and BRAVO Studies
- Active Biotech AB and Teva Pharmaceutical Industries Ltd Publish Pre-Planned Analysis of Phase III ALLEGRO Study
- Active Biotech AB to Present Further Analysis Supporting Effect of ANYARA in Biomarker Defined Subgroup
- Active Biotech AB and Teva Pharmaceutical Industries Ltd Announce Positive Results from Phase IIa Study of Laquinimod in Active Lupus Nephritis
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