WAYNE, N.J., June 4 /PRNewswire/ -- Bayer HealthCare will present a combined analysis from Phase I and II clinical trials evaluating the safety and efficacy of one of its lead investigational cancer treatments, Alpharadin™ (radium-223 chloride), in castration-resistant prostate cancer (CRPC) that has spread to the bones (metastases). These data, along with data from a Phase I pharmacokinetic and biodistribution study of Alpharadin, will be presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO), June 4-8, 2010, in Chicago, IL.
"The analysis of the Phase I and II data presented at ASCO helped to provide the basis for the ongoing global Phase III clinical trial of Alpharadin in CRPC," said Dr. Dimitris Voliotis, Vice President, Oncology Clinical Development, Bayer. "We are hopeful that the Alpharadin clinical program will aid in addressing treatment for bone metastases in CRPC patients."
Alpharadin Data at ASCO 2010
Abstract #4678 - An analysis of two open-label Phase I trials (n=37) and three double-blind Phase II trials (n=255) in CRPC patients with bone metastases was conducted. The trials included assessments of safety (hematology and adverse events), survival, prostate-specific antigen (PSA) levels, bone specific alkaline phosphatase (b-ALP) levels, pain and dosimetry (the calculation of the absorbed dose in tissue resulting from exposure to ionizing radiation). Dosing of Alpharadin in the trial varied from 5 to 250 kilobecquerel per kilogram, based on body weight (kBq/kg b.w.).
Abstract #4680 - Analysis of data from a Phase I pharmacokinetic and biodistribution study (BC1-08) with escalating doses of Alpharadin in men with bone metastases resulting from CRPC was conducted. Dose-limiting toxicity (DLT) of Alpharadin was assessed in ten patients during the first four weeks post treatment. No maximum tolerated dose for Alpharadin was reached in the study, up to 200 kBq/kg. The analysis also found that Alpharadin clears the blood and accumulates in bone metastases as early as 10 minutes from the time of injection.
Alpharadin (radium-223 chloride) is an investigational alpha-pharmaceutical in development for cancer patients with bone metastases (cancer that has spread to the bone). This compound is a calcium mimetic, alpha-emitting nuclide. Radium-based alpha-pharmaceuticals like Alpharadin mimic many of the behaviors of calcium in the body.
Alpharadin is currently being evaluated in a global Phase III, randomized, double-blind, multi-dose, placebo-controlled international clinical trial (ALSYMPCA) in men with CRPC with bone metastases. The potential clinical benefit of Alpharadin is also being evaluated in patients with breast cancer.
In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of Alpharadin. Under the terms of the agreement, Bayer will develop and commercialize Alpharadin globally, while Algeta retains an option for up to 50/50 co-promotion and profit-sharing in the United States.
About CRPC and Bone Metastases
Prostate cancer is the most common cancer among men in the United States and Northern European countries. In 2002, an estimated 680,000 men had prostate cancer and 220,000 died from the disease worldwide.
Castration-resistant prostate cancer (CRPC) was formerly known as hormone-refractory prostate cancer (HRPC). Approximately 90 percent of men with CRPC have radiological evidence of bone metastases. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to bone pain, fracture and other complications that can significantly impair a man's health. In fact, bone metastases are the main cause of disability and death in patients with CRPC.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
David Freundel (U.S. media)
Phone: +1 973 305 5310
Forward Looking Statements
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SOURCE Bayer HealthCare Pharmaceuticals Inc.