Oslo, Norway, 11 August 2010 - Algeta ASA (OSE: ALGETA), announces that it has treated the first patient in a phase I/IIa trial of Alpharadin in combination with docetaxel. The trial aims to recruit up to 60 men with bone metastases resulting from castration-resistant (hormone refractory) prostate cancer (CRPC). Docetaxel chemotherapy is the current standard treatment for metastatic CRPC.
Alpharadin (radium-223 chloride) is a first-in-class alpha-pharmaceutical with a highly tolerable safety profile that in clinical trials, has demonstrated potent antitumor effect targeting bone metastases in prostate cancer patients. In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of Alpharadin.
Alpharadin is currently being evaluated in a global Phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from CRPC, with overall survival as the primary endpoint. ALSYMPCA is recruiting from the approximately 50% of patients who are ineligible for treatment with docetaxel (based on clinical status and safety concerns) and those patients for whom chemotherapy is ineffective. This new combination study therefore will determine if the use of Alpharadin can be safely combined with docetaxel in patients who have bone metastases and can tolerate chemotherapy.
The new trial (BC1-10), being conducted at the Memorial Sloan-Kettering Cancer Center in New York and up to nine other centers in the USA, was initiated on schedule in June 2010, and is an open-label, randomized phase I/IIa study. The objective of the study is to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from CRPC, to investigate safety and to explore efficacy of the recommended combination dose.
In the first part of the study, Alpharadin will be administered intravenously in a dose-escalating regimen in combination with standard docetaxel treatment (every three weeks). The maximum dose of Alpharadin will be 50 kBq/kg body weight every six weeks for five cycles.
In the second part of the study, patients will be randomized to receive standard docetaxel treatment every three weeks, or Alpharadin in combination with standard docetaxel treatment at the recommended dose.
Michael J Morris, MD, Principal Investigator of the BC1-10 trial at the Memorial Sloan-Kettering Cancer Center, said, "Targeting both the tumor cell with chemotherapy and the bone microenvironment with an alpha-pharmaceutical such as Alpharadin is a novel approach and I am enthusiastic about leading this new study."
Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "We are pleased to begin the combination study with Alpharadin and docetaxel and especially excited to be working with Dr. Morris, an internationally recognized prostate cancer expert at the Memorial Sloan-Kettering Cancer Center, one of the world's leading cancer hospitals. This study is an important step in Alpharadin's development: if it can establish a safe Alpharadin dose in combination with chemotherapy and then demonstrate an efficacy benefit, this would suggest that we could potentially expand the population of prostate cancer patients who may benefit from treatment with Alpharadin."