Algeta announces first US patient randomized in ALSYMPCA phase III
study at Tulane Cancer Center, Ne
(Thomson Reuters ONE) - Oslo, Norway, 11 December - Algeta ASA (OSE: ALGETA), the cancertherapeutics company, announces that the first clinical center in theUS, the Tulane Cancer Center, New Orleans, has started randomizingpatients in the phase III clinical study of Alpharadin in men withcastration-resistant (also known as hormone-refractory) prostatecancer (CRPC) that has metastasized to the skeletonThe ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study is adouble-blind, randomized, controlled trial that enrols patients withCRPC and symptomatic bone metastases who will be randomized toreceive Alpharadin (radium-223 chloride) plus best standard of careor placebo plus best standard of care. Approximately 750 patients areexpected 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 completeby 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 Departmentsof Medicine and Urology at Tulane University School of Medicine atthe Tulane Cancer Center in New Orleans. The Tulane Cancer Center isone of the top cancer-focused medical centers in the US.Dr. Sartor is an internationally recognized medical oncologist withan interest in prostate cancer from both a basic research andclinical perspective. He is chair-elect of the US Department ofDefense Prostate Cancer Integration Panel and is co-editor-in-chiefof the peer-reviewed journal Clinical Genitourinary Cancer. He isalso the current medical oncology chair of the Genitourinary CancerCommittee of the Radiation Oncology Treatment Group, a leading USmulticenter research organization testing novel radiotherapyapproaches against cancer.Dr Sartor commented: "Alpharadin works by targeting and destroyingcancer cells in the bone while sparing healthy bone marrow tissue. Ifsuccessful in clinical trials, this compound could make a significantdifference for the large number of men whose cancer has spread to thebones. Patients most often die as a consequence of the metastases -not the primary cancer - so preventing cancer from spreading andcontrolling cancer that has spread is a major clinical challenge."Physicians interested in referring a qualified patient may go towww.algeta.com for further information about this study.Andrew Kay, Algeta's President and CEO said: "We are pleased to beginthe ALSYMPCA phase III study in the US and especially excited to beworking with Dr. Sartor, an internationally recognized prostatecancer expert at the Tulane Cancer Center, one of the world's leadingcancer hospitals. The enrolment of patients into US clinical centersis an important step in the overall clinical development ofAlpharadin and we expect further US clinical centers to come onlinein the coming months."In September, Algeta signed a USD 800 million agreement with BayerSchering Pharma AG for the development and global commercializationof Alpharadin.###For further information, please contactAndrew Kay, CEOGillies O'Bryan-Tear, CMOÿystein Soug, CFO+47 2300 7990 / +47 4840 1360 (mob)+47 23 00 7824 / +47 4804 1411 (mob)+47 2300 7990 / +47 9065 6525 (mob)post(at)algeta.comInternational media enquiries:Mark Swallow/Helena Galilee/David DibleCitigate Dewe Rogerson+44 207 638 9571mark.swallow(at)citigatedr.co.ukUS investor enquiries:Jessica LloydThe Trout Group+1 646 378 2928jlloyd(at)troutgroup.comAbout AlgetaAlgeta ASA is a cancer therapeutics company built on world-leading,proprietary technology. Algeta is developing a new generation oftargeted cancer therapeutics (alpha-pharmaceuticals) that harness theunique characteristics of alpha particle emitters and are potent,well-tolerated and convenient to use.Algeta's lead alpha-pharmaceutical candidate, Alpharadin (based onradium-223), has blockbuster potential for treating bone metastasesarising from multiple major cancer types, owing to its bone-targetingnature, potent efficacy (therapeutic and palliative) and benignsafety profile. Development of Alpharadin is most advanced targetingbone 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 acomprehensive phase II program. This trial is currently open forrecruitment.In September 2009, Algeta entered into a global agreement with BayerHealthcare AG for the development and commercialization ofAlpharadin. As part of the agreement, Algeta retains an option toco-promote Alpharadin in the United States and to share profits fromfuture sales.Algeta is also developing other technologies for deliveringalpha-pharmaceuticals. These include methods to enhance the potencyof therapeutic antibodies and other tumor-targeting molecules bylinking them to the alpha particle emitter thorium-227. The Companyis headquartered in Oslo, Norway, and was founded in 1997. Algetalisted on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).Alpharadin and Algeta are trademarks of Algeta ASA.Forward-looking StatementThis news release contains forward-looking statements and forecastsbased on uncertainty, since they relate to events and depend oncircumstances that will occur in the future and which, by theirnature, will have an impact on results of operations and thefinancial condition of Algeta. There are a number of factors thatcould cause actual results and developments to differ materially fromthose expressed or implied by these forward-looking statements.Theses factors include, among other things, risks associated withtechnological development, the risk that research & development willnot yield new products that achieve commercial success, the impact ofcompetition, the ability to close viable and profitable businessdeals, the risk of non-approval of patents not yet granted anddifficulties of obtaining relevant governmental approvals for newproducts.###http://hugin.info/134655/R/1360601/332066.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 11.12.2009 - 08:41 Uhr
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News-ID 9506
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