Algeta completes comprehensive phase II clinical program with Alpharadin for treating bone metastases

Results highlight the potential of Alpharadin to treat bone metastases in major cancer indications

16-Jan-2009 - Norway

Algeta ASA announced that with the results of the BC1-04 study it has completed its comprehensive phase II clinical program evaluating Alpharadin (radium-223) as a new treatment for bone metastases in patients with hormone-refractory prostate cancer (HRPC). The program provides strong evidence that Alpharadin can prolong patient survival times, improve quality of life and offers a placebo-like safety profile.

These clinical results combined with Alpharadin's bone-targeting properties highlight the potential of this new cancer therapeutic to be a first-choice treatment for bone metastases that frequently arise from a number of high incidence cancers as well as HRPC (e.g. breast, lung and thyroid). Bone metastases are a serious consequence of certain advanced cancers causing intractable and debilitating pain as well as further reducing life expectancy.

In addition, the results, including data from the final trial in the program (BC1-04; outlined below)), suggest that Alpharadin has an ideal profile to be used in combination with other cancer therapies.

The Alpharadin phase II program comprised three trials and involved 286 individuals. It was designed to provide detailed information on the safety and therapeutic efficacy of different doses of Alpharadin in HRPC patients, both symptomatic and asymptomatic for bone metastases, as well as evaluating its ability to relieve pain caused by bone metastases in symptomatic patients. In all three phase II trials completed, the primary efficacy endpoints were met while providing compelling evidence of the benign, placebo-like safety profile of Alpharadin. In addition, data from the BC1-04 study supports an optimal therapeutic dose level of 50 kBq/kg as selected for use in the global phase III ALSYMPCA trial (see below for further details).

Furthermore, the successful completion of the phase II program also supports Algeta's strategy for targeting Alpharadin at patients with metastatic HRPC who are unsuitable or who have failed docetaxel chemotherapy and for first-line use in combination with docetaxel. A combination study is in preparation, which if successful will enable Algeta to market Alpharadin, either alone or in combination with docetaxel, to approximately 85% of the global HRPC market.

https://www.bionity.com/en/news/93606/algeta-completes-comprehensive-phase-ii-clinical-program-with-alpharadin-for-treating-bone-metastases.html