Promising New Therapeutic Targets Bone and Disperses Radiation
Alpharadin may decreases bone metastases and reduce death
February 2, 2012 -- Approximately 90 percent of men with castration-resistant prostate cancer show bone metastases which are the main cause of debilitating pain, weakened bones and a reduced survival in patients with advanced prostate cancer. On June 6, 2011, Bayer Healthcare Pharmaceuticals Inc. announced a successful Phase III trial evaluating a new therapy for advanced prostate cancer using a radiopharmaceutical, Alpharadin (Rad223) that improves overall survival of patients. The overall survival of patients treated with Alpharadin was higher (14 months) than those receiving placebo (11.2 months) for a 2.8 month improvement in overall survival for these patients
with severely advanced disease.
Alpharadin reduces the risk of death by 30% and was proven so effective that in early June 2011 the Independent Data Monitoring Committee (part of the FDA) recommended Phase III clinical trials be stopped and all patients on placebo be given the drug. In late August 2011, Alpharadin was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The therapeutic is currently pending approval in both the United States and Europe.
The therapeutic effects of Alpharadin are derived from its direct targeting to bone metastases and potent and localized tumor cell-killing activity in a 10-cell radius. Alpharadin is radium which emits alpha particle radiation that specifically targets the bone and kills cancer cells. The half-life of this radiopharmaceutical (11.4 days) makes it ideal for cancer therapy.
The Prostate Cancer Foundation was the first foundation to fund the proof of concept of alpha-pharmaceuticals at University of Texas MD Anderson Cancer Center through Dr. Christopher J. Logothetis.
Learn more about Alpharadin here
And its fast-track progress to approval here
About Fast Track Designation in the United States:
Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. Fast Track addresses a broad range of serious diseases. Fast Track designation must be requested by the drug company and can be initiated at any time during the drug development process. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.