The new US trial (BC1-08) will be a phase I open label, ascending dose study of Alpharadin (radium-223 chloride) in up to 18 HRPC patients and will be conducted at the Memorial Sloan-Kettering Cancer Center (MSKCC) in New York. The trial will evaluate the pharmacokinetics and biodistribution of Alpharadin in relation to dose and will further expand the information obtained in a similar phase I study (BC1-05), which completed earlier this year. Each patient will be administered a single intravenous injection of Alpharadin and the activity will be measured in the whole body and regions of interest, including the skeleton and the sites of bone metastases. The first group of patients will receive a dose of 50 kBq/kg, the next 100 kBq/kg, and the final group will receive 200 kBq/kg body weight (0.0014, 0.0027 and 0.0054 mCi/kg).
The principal investigator of the US trial at MSKCC, Michael Morris M.D., said: “We are looking forward to introducing this promising new therapy option to US patients”.
The earlier BC1-05 study confirmed that Alpharadin is rapidly taken up in the bone, the primary site of its therapeutic action, and any that is not taken up by the bone is rapidly excreted from the body, mainly via faeces. There was no specific uptake in normal organs such as the kidneys or the liver resulting in very low absorbed doses to these organs. The patients received two intravenous injections of Alpharadin at a therapeutic dose of 100 kBq/kg body weight six weeks apart and the results were similar after both injections. The results confirm the safety and benign side-effect profile of Alpharadin.
Dr. Thomas Ramdahl, President and CEO of Algeta, said: “We are delighted to begin this important US trial with Alpharadin and to be working with the MSKCC, one of the world’s leading cancer centers. The start of this US clinical trial is an important step in our overall clinical development of Alpharadin and we hope it will lead the way towards more widespread evaluation of Alpharadin in US cancer centers after further discussions with FDA later this year.”