Algeta announces positive preliminary bone marker results in a phase IIa study evaluating Alpharadin in breast cancer patients with bone metastases

08-Jun-2011 - Norway

Algeta ASA announced that preliminary data from its phase IIa study of Alpharadin (radium-223 chloride) for the treatment of bone metastases in 23 patients with endocrine-refractory breast cancer showed positive results for bone markers.

Preliminary top-line results showed that Alpharadin reduced the levels of bone alkaline phosphatase (bALP), and urine N-telopeptide (uNTX). These parameters are used as key markers of bone involvement in breast cancer.

Alpharadin was also found to be safe and well-tolerated in the study.

Final analysis of this trial, including the primary and secondary endpoints, will be presented at an upcoming congress. The results will also be submitted for publication in a peer-reviewed journal.

Gillies O’Bryan-Tear, Algeta's Chief Medical Officer, said: "These preliminary results are encouraging for patients with bone metastases in breast cancer, who do not always respond well to current treatments; we await the full results of the trial which will be presented at an upcoming medical congress”.

Prof. Robert Coleman, a cancer specialist at the Weston Park Hospital in Sheffield and Principal Investigator for the trial, said: “Bone metastases cause significant distress for patients and may respond poorly to current modalities of treatment. We are encouraged that Alpharadin has shown efficacy against key markers of bone disease in these breast cancer patients. If Alpharadin can show positive results in larger trials in breast cancer, then it may become an important new therapy for women with limited treatment options.”

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