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Algeta Reports Positive Headline Phase II Data on Pain Palliation With Alpharadin
Date:8/28/2008

kaline phosphatase (ALP) ranging from no effect in the lowest dose group to a marked reduction in the higher dose groups. ALP is a severity marker of bony metastatic disease and of prognostic importance.

The study has also further confirmed the safety of Alpharadin and shown its benign side-effect profile. In fact, the higher the dose of Alpharadin that patients received, the fewer adverse events were experienced. This reproduces the safety profile of the earlier BC1-02 Phase II study where the Alpharadin group experienced fewer adverse effects than the placebo comparator group. Importantly for a drug in this clinical setting no significant bone marrow toxicity was observed in patients receiving Alpharadin.

The full results of the BC1-03 study will be submitted for publication in a peer-reviewed journal.

The principal investigator of the study Professor Sten Nilsson at the Karolinska Hospital in Stockholm said: "These results showing the beneficial impact of Alpharadin in terms of pain palliation are important, as improved quality of life, alongside increased survival, are the two key goals of anti-cancer therapy of patients with skeletal metastases."

Commenting on today's further positive news with Alpharadin, Algeta's President and CEO, Dr. Thomas Ramdahl, 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.

Based on our clinical trials to-date I am very confident that Alpharadin has the potential to become an important new therapy for patients with prostate cancer. This view has been reinforced by the enthusiastic and positive response we have received from key opinion leaders around the world to our unique approach to treating HRPC."

Algeta has recently started enrolling patients for the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic
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SOURCE Algeta
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