Positive Ph II data on Algeta's Alpharadin

Algeta, a Norwegian cancer therapeutics company, says that the primary objective of its BC1-03 Phase II pain palliation study was met. This showed that even single doses of Alpharadin (radium-223 chloride) in patients with painful bone metastases could produce increasing clinical benefit with increasing dose. Pain palliation is an important quality-of-life benefit in metastatic cancer patients. 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 observed.

In men with HRPC life expectancy can be as short as 18 months, and it is estimated that 100,000 men in the European Union and USA die from the disease each year. In 85% of these men the tumor will have spread into the bones. These metastases are a significant problem as they can cause intractable and debilitating pain as well as contributing to a further reduction in life expectancy.

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 has shown the beneficial palliative effect of a single dose of Alpharadin and that there is a clear dose-response effect, with higher doses providing better pain relief.