Tulane Cancer Center starts randomizing patients in phase III clinical study of Alpharadin

Dec 14 2009

Algeta ASA (OSE: ALGETA), the cancer therapeutics company, announces that the first clinical center in the US, the Tulane Cancer Center, New Orleans, has started randomizing patients in the phase III clinical study of Alpharadin in men with castration-resistant (also known as hormone-refractory) prostate cancer (CRPC) that has metastasized to the skeleton.

The ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study is a double-blind, randomized, controlled trial that enrols patients with CRPC and symptomatic bone metastases who will be randomized to receive Alpharadin (radium-223 chloride) plus best standard of care or placebo plus best standard of care. Approximately 750 patients are expected to be enrolled at more than 125 medical centers worldwide. Algeta expects to enroll patients across up to 15 sites in the US. Global recruitment remains on schedule and is expected to be complete by the second half of 2010.

The Principal Investigator of the ALSYMPCA study in the US is Dr. Oliver Sartor, Piltz Professor of Cancer Research in the Departments of Medicine and Urology at Tulane University School of Medicine at the Tulane Cancer Center in New Orleans. The Tulane Cancer Center is one of the top cancer-focused medical centers in the US.

Dr. Sartor is an internationally recognized medical oncologist with an interest in prostate cancer from both a basic research and clinical perspective. He is chair-elect of the US Department of Defense Prostate Cancer Integration Panel and is co-editor-in-chief of the peer-reviewed journal Clinical Genitourinary Cancer. He is also the current medical oncology chair of the Genitourinary Cancer Committee of the Radiation Oncology Treatment Group, a leading US multicenter research organization testing novel radiotherapy approaches against cancer.

Dr Sartor commented: "Alpharadin works by targeting and destroying cancer cells in the bone while sparing healthy bone marrow tissue. If successful in clinical trials, this compound could make a significant difference for the large number of men whose cancer has spread to the bones. Patients most often die as a consequence of the metastases - not the primary cancer - so preventing cancer from spreading and controlling cancer that has spread is a major clinical challenge."

Physicians interested in referring a qualified patient may go to http://www.algeta.com for further information about this study.

Andrew Kay, Algeta's President and CEO said: "We are pleased to begin the ALSYMPCA phase III study in the US and especially excited to be working with Dr. Sartor, an internationally recognized prostate cancer expert at the Tulane Cancer Center, one of the world's leading cancer hospitals. The enrolment of patients into US clinical centers is an important step in the overall clinical development of Alpharadin and we expect further US clinical centers to come online in the coming months."

In September, Algeta signed a USD 800 million agreement with Bayer Schering Pharma AG for the development and global commercialization of Alpharadin.