ALSYMPCA - for healthcare professionals.

The primary efficacy endpoint of the ALSYMPCA trial is overall survival. Patients are being randomized 2-to-1 in favor of Alpharadin^®, which is administered as a single intravenous injection every four weeks for six cycles.

Secondary endpoints include time to occurrence of specified disease-related events, and time to progression of certain key biomarkers indicative of disease status, including blood levels of serum PSA (prostate-specific antigen) and bone alkaline phosphatase (ALP).

In addition, the trial is monitoring and evaluating both the acute and long-term safety profiles of Alpharadin^® treatment as well as its impact on quality of life.

Phase I and II program

The Alpharadin^® phase I and II program involved over 340 patients.

Key findings were that:

• Alpharadin^® treatment showed significant increased survival – median of 4.5 months vs placebo (p=0.017); current gold standard treatment (docetaxel) provides approx. 10 weeks survival benefit.
• In all trials conducted to date, Alpharadin^® was consistently well-tolerated with a benign side-effect profile, e.g. constipation (Please see the Lancet article for further information). This side-effect profile combined with efficacy suggests Alpharadin^® has an ideal profile for use alone or in combination with current cancer therapies (e.g. bisphosphonates, docetaxel, opioids)
• Alpharadin^® alleviated pain in a dose-dependent manner thereby improving patient quality of life.
• Blood levels of several biomarkers indicated of a positive therapeutic effect, such as reduction of PSA and bone ALP levels.