OSLO, December 11 /PRNewswire/ -- Algeta ASA , 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.
Algeta ASA is a cancer therapeutics company built on world-leading, proprietary technology. Algeta is developing a new generation of targeted cancer therapeutics (alpha-pharmaceuticals) that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.
Algeta's lead alpha-pharmaceutical candidate, Alpharadin (based on radium-223), has blockbuster potential for treating bone metastases arising from multiple major cancer types, owing to its bone-targeting nature, potent efficacy (therapeutic and palliative) and benign safety profile. Development of Alpharadin is most advanced targeting bone metastases resulting from hormone-refractory prostate cancer (HRPC), and it entered an international phase III clinical trial (ALSYMPCA) in mid-2008 based on compelling clinical results from a comprehensive phase II program. This trial is currently open for recruitment.
In September 2009, Algeta entered into a global agreement with Bayer Healthcare AG for the development and commercialization of Alpharadin. As part of the agreement, Algeta retains an option to co-promote Alpharadin in the United States and to share profits from future sales.
Algeta is also developing other technologies for delivering alpha-pharmaceuticals. These include methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227. The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 .
Alpharadin and Algeta are trademarks of Algeta ASA.
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.
Andrew Kay, CEO +47-23-00-7990 / +47-4840-1360 (mob) Gillies O'Bryan-Tear, CMO +47-23-00-7824 / +47-4804-1411 (mob) 0ystein Soug, CFO +47-23-00-7990 / +47-9065-6525 (mob) firstname.lastname@example.org International media enquiries: +44-207-638-9571 Mark Swallow/Helena Galilee/David email@example.com Dible Citigate Dewe Rogerson US investor enquiries: +1-646-378-2928 Jessica Lloyd firstname.lastname@example.org The Trout Group
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