Algeta announces first patient treated in phase II trial of Alpharadin to treat bone metastases in breast cancer
Clinical study underway in second tumor type
Algeta ASA announced that it has treated the first patient in a phase II clinical study with Alpharadin for bone metastases resulting from endocrine-refractory breast cancer. This is the second tumor type under investigation with Alpharadin, the first being prostate cancer.
Algeta's lead product Alpharadin (based on radium-223) is a first-in-class, highly targeted alpha-pharmaceutical under clinical evaluation to improve survival in patients with bone metastases from advanced cancer. Its localized action helps preserve the surrounding healthy tissue thereby limiting side-effects.
The new trial (BC1-09) will recruit 20 women with breast cancer that has spread primarily to the bone and that no longer responds to endocrine therapy. It will be conducted at cancer centers in Oslo (Norway), Brussels (Belgium) and Sheffield (UK). Patients will receive one intravenous injection of Alpharadin (radium-223 chloride), 50 kBq/kg b.w., every four weeks for four cycles.
The objective of the study is to examine whether Alpharadin has a clinically relevant effect on several biomarkers for bone turnover during the 16-week treatment period. The trial will also monitor the safety of Alpharadin treatment in these patients. In an earlier Phase I study, safety data were collected from women with bone metastases from breast cancer as part of the wider Alpharadin clinical program. The results showed that Alpharadin has a benign side-effect profile in these patients and were consistent with safety findings in men with prostate cancer.
Alpharadin is in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from prostate cancer. Recruitment of patients into this trial continues to progress very well and is expected to complete enrolment of 750 patients on schedule in the second half of 2010.
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