Algeta's Alpharadin has potential as a treatment for bone metastases in prostate cancer patients
Algeta ASA, a therapeutics company dedicated to the development of novel anticancer agents based on alpha particle emitting radionuclides, announced that an analysis of the biomarker data from a Phase II trial of its lead product Alpharadin(TM) (radium-223) continues to demonstrate its potential as a treatment for bone metastases in hormone-refractory prostate cancer (HRPC) patients. Data from this trial (BC1-02) were presented at the 2006 Prostate Cancer Symposium in San Francisco, CA.
Algeta is conducting trial BC1-02 as part of its Phase II clinical program for Alpharadin(TM), a novel radiopharmaceutical based on the alpha particle emitter radium-223, which naturally targets and attacks skeletal metastases. The double-blind placebo-controlled trial involves 64 patients with painful skeletal metastases as a consequence of HRPC and is in its follow-up phase at 11 centers in Norway, Sweden and the UK. The trial was fully enrolled in May 2005.
The trial results presented are based on four-month follow-up data. Alpharadin(TM) treatment met the primary endpoint of the trial. There was a highly statistically significant decrease of bone-alkaline phosphatase (bone-ALP) compared to placebo (ITT: p<0.001). Strong demonstration of Alpharadin's effect on other markers of bone turnover, S-PINP (bone formation) and S-CTX-I and S-ICTP (bone resorption), were also observed.
Interesting PSA (prostate specific antigen) results were demonstrated with a significantly better PSA response in patients given Alpharadin(TM) compared to placebo. Together, these data show that Alpharadin(TM) treatment has a clear effect on the microenvironment of bone metastases indicative of a positive therapeutic effect.
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