Algeta Drug Shows Promise in Phase II Trial
Posted on: Monday, 27 February 2006, 12:01 CST
Analysis of the biomarker data from a phase II trial of Algeta's lead product Alpharadin has demonstrated the potential of the drug as a treatment for bone metastases in hormone-refractory prostate cancer patients.
Algeta, headquartered in Norway, is conducting the trial as part of its phase II clinical program for Alpharadin, a novel radiopharmaceutical based on the alpha particle emitter radium-223, which naturally targets and attacks skeletal metastases.
The placebo-controlled trial involves 64 patients with painful skeletal metastases as a consequence of hormone-refractory prostate cancer (HRPC) and is in its follow-up phase at 11 centers in Norway, Sweden and the UK.
In the trial the drug achieved a highly statistically significant decrease of bone-alkaline phosphatase compared to placebo. Strong demonstration of Alpharadin's effect on other markers of bone turnover, bone formation and bone resorption, were also observed.
"While only biomarker data have been analyzed at this stage, the indication is that Alpharadin is having a therapeutic effect on bone metastases. We will evaluate clinical outcomes in patients at the 12-month follow-up stage, but evidence is mounting to suggest that this targeted approach to treating bone metastases has great potential," stated Professor Sten Nilsson, head of the Urologic Oncology Group at the Karolinska Hospital.
Data from this trial were presented in a poster presentation at the 2006 Prostate Cancer Symposium in San Francisco.
Source: Datamonitor
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