Clinical Analyses from Alpharadin Clinical Program Presented at ASCO
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Algeta ASA announces that analyzes of clinical data from its phase I and phase II clinical program with Alpharadin will be presented at the 46th Annual Meeting of the American Society for Clinical Oncology (ASCO), 4-8 June 2010 in Chicago, USA.
Alpharadin (radium-223 chloride), being developed by Algeta and Bayer Schering Pharma AG, is a first-in-class alpha-pharmaceutical that has demonstrated in clinical trials a potent and highly targeted antitumor effect on bone metastases in cancer patients combined with a highly tolerable side-effect profile.
Alpharadin is currently being evaluated in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from castration-resistant (hormone-refractory) prostate cancer (CRPC), with overall survival as the primary endpoint.
Highlights of the analysis of the clinical data presented at ASCO are:
• A combined safety analysis from 292 patients who received Alpharadin in the phase I and phase II studies confirmed its highly tolerable side-effect profile. The incidence of haematological toxicity was very low and there was no observed renal or hepatic toxicity.
• Analysis of data from a phase I pharmacokinetic and biodistribution study with escalating doses of Alpharadin found that Alpharadin rapidly cleared the blood and began accumulating in bone metastases within ten minutes of injection.
• Analysis of biodistribution and dosimetry data from the phase I program showed that Alpharadin was rapidly and specifically taken up by bone and the remainder was rapidly excreted, predominantly through the gastrointestinal tract.
• The rapid localization of Alpharadin to bone metastases combined with its emission of very short-range and potent alpha radiation may account for the highly tolerable safety profile observed in phase I and II studies.
Gillies O’Bryan-Tear, Algeta’s Chief Medical Officer, said, “It is rare to see such a favorable safety profile in a new oncology candidate. The tolerability of Alpharadin combined with the evidence from a phase II that it can confer a significant survival benefit and improve patients’ quality of life continues to give us great confidence in Alpharadin’s potential to address the devastating impact of bone metastases in cancer patients.”
Alpharadin (radium-223 chloride), being developed by Algeta and Bayer Schering Pharma AG, is a first-in-class alpha-pharmaceutical that has demonstrated in clinical trials a potent and highly targeted antitumor effect on bone metastases in cancer patients combined with a highly tolerable side-effect profile.
Alpharadin is currently being evaluated in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from castration-resistant (hormone-refractory) prostate cancer (CRPC), with overall survival as the primary endpoint.
Highlights of the analysis of the clinical data presented at ASCO are:
• A combined safety analysis from 292 patients who received Alpharadin in the phase I and phase II studies confirmed its highly tolerable side-effect profile. The incidence of haematological toxicity was very low and there was no observed renal or hepatic toxicity.
• Analysis of data from a phase I pharmacokinetic and biodistribution study with escalating doses of Alpharadin found that Alpharadin rapidly cleared the blood and began accumulating in bone metastases within ten minutes of injection.
• Analysis of biodistribution and dosimetry data from the phase I program showed that Alpharadin was rapidly and specifically taken up by bone and the remainder was rapidly excreted, predominantly through the gastrointestinal tract.
• The rapid localization of Alpharadin to bone metastases combined with its emission of very short-range and potent alpha radiation may account for the highly tolerable safety profile observed in phase I and II studies.
Gillies O’Bryan-Tear, Algeta’s Chief Medical Officer, said, “It is rare to see such a favorable safety profile in a new oncology candidate. The tolerability of Alpharadin combined with the evidence from a phase II that it can confer a significant survival benefit and improve patients’ quality of life continues to give us great confidence in Alpharadin’s potential to address the devastating impact of bone metastases in cancer patients.”
