Algeta Announces First US Patient Randomized In ALSYPA Phase III Study At Tulane ancer enter, New Orleans

Algeta ASA OS: ALGTA, the cancer therapeutics company, announces that the first clinical center in the US, the Tulane ancer enter, 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 RP that has metastasized to the skeleton

The ALSYPA ALpharadin in SYptomatic Prostate Ancer study is a double-blind, randomized, controlled trial that enrols patients with RP 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 ALSYPA study in the US is Dr Oliver Sartor, Piltz Professor of ancer Research in the Departments of edicine and Urology at Tulane University School of edicine at the Tulane ancer enter in New Orleans The Tulane ancer enter 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 ancer Integration Panel and is co-editor-in-chief of the peer-reviewed journal linical Genitourinary ancer He is also the current medical oncology chair of the Genitourinary ancer ommittee 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 metastasesnot the primary cancerso preventing cancer from spreading and controlling cancer that has spread is a major clinical challenge”

Andrew Kay, Algeta’s President and O said: “We are pleased to begin the ALSYPA phase III study in the US and especially excited to be working with Dr Sartor, an internationally recognized prostate cancer expert at the Tulane ancer enter, 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

About Algeta

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 HRP, and it entered an international phase III clinical trial ALSYPA 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 ompany is headquartered in Oslo, Norway, and was founded in 1997 Algeta listed on the Oslo Stock xchange in arch 2007 Ticker: ALGTA

Alpharadin and Algeta are trademarks of Algeta ASA

Forward-looking Statement

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

Source: Algeta

source : www.medicalnewstoday.com

Related News:

• Shea May Slow Arthritis
• Ortho Kinematics Launches Multi-Site Clinical Study Of KineGraph VMA™
• Middle school students co-author research on enzyme for activating promising disease-fighters
• Sea Buckthorn May Soothe Dry Eye Syndrome
• Cerebral Palsy Study Dispels Inflated Costs And Biases
• Proposed Lowering Of PSA Threshold For Biopsy Could Result In Increased Overdiagnosis And Overtreatment Of Prostate Cancer, Study
• Neurobiologists Can Now Activate Specific Nerve Cells To Study The Association Between Sensations And Negative Experiences
• NPS Pharmaceuticals Announces Completion Of Patient Randomization In Phase 3 STEPS Study Of GATTEX(R) In Short Bowel Syndrome
• Celiacs Need Vitamins To Help Stave Off Bone Disease
• Pool chemicals linked to disease

Details :
Submited at Monday, December 14th, 2009 at 7:42 pm on Endocrinology by robert
Comment RSS 2.0 - leave a comment - trackback