Algeta ASA (OSE: ALGETA) announced its late-breaking data to be presented at ASCO meeting oral session tomorrow early this morning. The data from pivotal phase III trial called ALSYMPCA with its investigational drug Alpharadin (radium-223 dichloride) in advanced prostate cancer that has spread to bone now shows an overall survival improvement of 44%, with a highly significant P-value. The median survival benefit went up from 2.8 months at the interim analysis in June last year to 3.6 months (14.9 months vs. 11.3 months. Additionally a delay in time to skeletal-related events was observed according to Algeta.
Algeta touts this as the first data to show an overall survival benefit for patients in castration-resistant prostate cancer that has spread to bone in a phase 3 trial. The drug is partnered globally with Bayer Pharma AG (FWB: BAYN ) while Algeta maintains co-promotion rights in the US. The companies plan to submit for marketing approval based on this data in the US and Europe in H2 2012. The drug candidate has been granted Fast Track designation by the FDA. Furthermore the aim is to start new combination trials in prostate cancer and also to commence studies in breast cancer and osteosarcoma.
No comments:
Post a Comment