Algeta’s Phase II pain palliation study meets endpoint

The study showed that even single doses of Alpharadin in patients with painful bone metastases could produce increasing clinical benefit with increasing dose. The trial also confirmed Alpharadin’s benign side-effect profile and, importantly for a drug in this clinical setting, no significant bone marrow toxicity was said to be observed.

The BC1-03 study was a double-blind randomized pain control study comparing the palliative effects of four different single dose levels of Alpharadin in patients with bony metastatic hormone refractory prostate cancer (HRPC). The drug was given by i.v. injection mainly on an outpatient basis.

The palliative efficacy of Alpharadin was measured using an assessment of bone pain as well as the patient’s consumption of analgesia. The primary study objective was to investigate whether there was a dose-response relationship with respect to pain palliation in this patient group.

The study also showed a dose-dependent reduction in bone alkaline phosphatase (ALP) ranging from no effect in the lowest dose group to a marked reduction in the higher dose groups. ALP is said to be a severity marker of bony metastatic disease and of prognostic importance.

Thomas Ramdahl, Algeta’s president and CEO, said: “These results build on the positive Phase II clinical data package that we have already assembled with Alpharadin, the highlight of which was the significant survival benefits that we have already reported in patients with HRPC.”