Algeta ASA (OSE: ALGETA), has announced that it will begin to enroll US survivors into its Alsympca phase III trial evaluating Alpharadin (radium-223). Alpharadin is designed to be used as a treatment for bone metastases in prostate cancer survivors with hormone-refractory prostate cancer (HRPC). The announcement of the trial follows a successful end-of-phase II meeting with the US Food and Drug Administration (FDA).
This trial is all ready been on-going since June 2008 in Europe. Recruitment of US survivors into the study is now planned to commence this year. They anticipate enrolling 750 HRPC patients with bone metastases.
In the phase II trials, Alpharadin demonstrated strong evidence that it can prolong patient survival times, improves quality of life and offers a placebo-like safety profile. The drug targets bone metastases (mets). It may also prove to be of value in other cancers that cause bone mets (breast, lung and kidney cancers). Bone mets cause intractable and debilitating pain as well as reducing life expectancy.
About the ALSYMPCA phase III clinical study
The ALSYMPCA study is a double-blind, randomized, controlled trial that enrolls symptomatic HRPC patients who will be randomized to receive Alpharadin plus best standard of care or placebo plus best standard of care.
The primary efficacy endpoint of the trial is overall survival. Patients are being randomized 2-to-1 in favor of Alpharadin, which will be given as six injections of 50 kBq/kg body weight, four weeks apart. Secondary endpoints include time to occurrence of specified disease-related events, and time to progression of certain key biomarkers indicative of disease status, including blood levels of serum prostate-specific antigen (PSA) and total alkaline phosphatase (ALP). In addition, the trial will monitor and evaluate both the acute and long-term safety profiles of Alpharadin treatment as well as its impact on quality of life.
For more information on the ALSYMPCA trial, please go to https://web.archive.org/web/20190201125234/https://www.algeta.com/ and click on the ALSYPMCA link in the menu bar.
The company will now work develop clinical settings in the United State to set up the trial locations. The brief description of the drug as well as its low morbidity issues coupled with the drugs supposed ability to extend life sounds like it could become a “keeper”. Clearly, we need to continue following this study. The trial, once it starts, may also be a trial worth considering joining.
Joel T Nowak, MA, MSW
Leave A Comment