Algeta Announces First Patient Treated in Phase II trial of Alpharadin to Treat Bone Metastases in Breast Cancer
News Feb 02, 2010
Algeta ASA has announces 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.
Prof. Robert Coleman, a cancer specialist at the Weston Park Hospital in Sheffield and Principal Investigator for the trial, said “Bone metastases are a frequent and devastating development of breast cancer as it advances, leading to a dramatic deterioration in patient health. If Alpharadin can replicate the clinical benefits it has shown in men with prostate cancer then it may be an important new therapy for women with limited treatment options.”
Andrew Kay, Algeta’s President and CEO said: “We believe that Alpharadin’s great potential lies in its mode of action that suggests it is likely to target and destroy bone metastases in several different tumor types from which bone metastases spread. We have seen highly encouraging results in our clinical studies with Alpharadin in men with prostate cancer that has spread to the bone, including improved survival benefit, pain relief and a benign side effect profile. Success in this new trial in women with breast cancer will address another unmet medical need in this large patient group as well as extending Alpharadin’s commercial potential as a first-choice treatment for bone metastases.”
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.
In September 2009, Algeta entered into a $800 million global agreement with Bayer Schering Pharma AG for the development and commercialization of Alpharadin. As part of the agreement, Algeta retains an option to co-promote Alpharadin in the United States and to share profits from future sales.