Algeta is pleased to announce that the first UK patient has been included in a phase II study of the novel bone seeking radiopharmaceutical Alpharadin(TM) based on radium-223.
First patient in United Kingdom has been included in Algeta's phase II trial of the alpha particle emitter Alpharadin(TM) (Radium-223) in men with skeletal metastases from prostate cancer
Algeta is pleased to announce that the first UK patient has been included in a phase II study of the novel bone seeking radiopharmaceutical Alpharadin(TM) based on radium-223. Alpharadin(TM), an alpha particle emitting radiopharmaceutical, is being evaluated as a potential therapy of skeletal metastases. The recently initiated phase II randomized, placebo-controlled, multicenter trial will investigate the safety and efficacy of multiple injections of Alpharadin(TM) in prostate cancer patients. The study is the first formal clinical trial with an alpha particle emitter ever being conducted in the United Kingdom.
"We are extremely pleased to have extended our phase II clinical trial outside Scandinavia to include highly reputable UK hospitals like the Royal Marsden Hospital" said Thomas Ramdahl, PhD, President and CEO of Algeta. "We are encouraged by the results from our phase I trial and Alpharadin's potential to address unmet medical need for patients with skeletal metastases".
This is a multi-center, randomized, placebo-controlled study of Alpharadin(TM) administered intravenously on an out-patient basis after local field external beam radiation of painful skeletal metastases in men with advanced prostate cancer. A total of 60 patients are expected to enroll in the study which will be conducted by Swedish, Norwegian and UK hospitals. The main objectives will be to study the delay of disease progression, quality of life and survival of the patients, in addition to safety of the treatment.
Alpharadin(TM) is the first alpha particle emitting radiopharmaceutical to enter a phase II clinical trial in treatment of solid tumors. It is based on the bone seeking radionuclide radium-223 with a half-life of 11.4 days. Significant antitumor effect has been shown in a treatment resistant skeletal metastases preclinical model. A clinical phase I trial has demonstrated a low toxicity and shown that therapeutic relevant doses can be administrated repeatedly with minimal side effects.
Prostate cancer is one of the most common cancers diagnosed among men in the Western World. In the European Union an estimated 145,000 new cases are diagnosed and there are 56,000 deaths every year. In the United States the corresponding numbers are 220,000 and 36,000, respectively. There are currently a great unmet medical need for slowing or stopping the progression of skeletal metastases from advanced prostate cancer, and relieving or delaying the onset of such disease-related pain.