Algeta announces first patient treated in phase II trial of Alpharadin to treat bone metastases in b

(Thomson Reuters ONE) - Clinical study underway in second tumor typeOslo, Norway, 2 February 2010 - Algeta ASA (OSE: ALGETA), the cancertherapeutics company, announces that it has treated the first patient in a phaseII clinical study with Alpharadin for bone metastases resulting fromendocrine-refractory breast cancer. This is the second tumor type underinvestigation with Alpharadin, the first being prostate cancer.Algeta's lead product Alpharadin (based on radium-223) is a first-in-class,highly targeted alpha-pharmaceutical under clinical evaluation to improvesurvival in patients with bone metastases from advanced cancer. Its localizedaction helps preserve the surrounding healthy tissue thereby limitingside-effects.The new trial (BC1-09) will recruit 20 women with breast cancer that has spreadprimarily to the bone and that no longer responds to endocrine therapy.  It willbe conducted at cancer centers in Oslo (Norway), Brussels (Belgium) andSheffield (UK). Patients will receive one intravenous injection of Alpharadin(radium-223 chloride), 50 kBq/kg b.w., every four weeks for four cycles.The objective of the study is to examine whether Alpharadin has a clinicallyrelevant effect on several biomarkers for bone turnover during the 16-weektreatment period.[1]  The trial will also monitor the safety of Alpharadintreatment in these patients. In an earlier Phase I study, safety data werecollected from women with bone metastases from breast cancer as part of thewider Alpharadin clinical program. The results showed that Alpharadin has abenign side-effect profile in these patients and were consistent with safetyfindings in men with prostate cancer.Prof. Robert Coleman, a cancer specialist at the Weston Park Hospital inSheffield and Principal Investigator for the trial, said "Bone metastases are afrequent and devastating development of breast cancer as it advances, leading toa dramatic deterioration in patient health. If Alpharadin can replicate theclinical benefits it has shown in men with prostate cancer then it may be animportant new therapy for women with limited treatment options."Andrew Kay, Algeta's President and CEO said: "We believe that Alpharadin's greatpotential lies in its mode of action that suggests it is likely to target anddestroy bone metastases in several different tumor types from which bonemetastases spread. We have seen highly encouraging results in our clinicalstudies with Alpharadin in men with prostate cancer that has spread to the bone,including improved survival benefit, pain relief and a benign side effectprofile. Success in this new trial in women with breast cancer will addressanother unmet medical need in this large patient group as well as extendingAlpharadin's commercial potential as a first-choice treatment for bonemetastases."Alpharadin is in a global phase III clinical trial (ALSYMPCA) to treat bonemetastases resulting from prostate cancer. Recruitment of patients into thistrial continues to progress very well and is expected to complete enrolment of750 patients on schedule in the second half of 2010.In September 2009, Algeta entered into a $800 million global agreement withBayer Schering Pharma AG for the development and commercialization ofAlpharadin. As part of the agreement, Algeta retains an option to co-promoteAlpharadin in the United States and to share profits from future sales.Bone Metastases and Breast CancerSources: Cancer Research UK, American Cancer Society, World Health OrganizationThe development of bone metastases represents a serious development for cancerpatients as they are associated with a dramatic decline in patient health andquality of life, ultimately leading to death. Bone metastases represent a majorunmet medical need, occurring in up to 90% of certain late-stage cancers, e.g.prostate, breast and lung.·         Breast cancer is by far the most common cancer in females, accountingfor around 31% of all female cancers·         Breast cancer accounted for more than half a million deaths worldwidein 2004·         Nearly 200,000 new cases of invasive breast cancer were diagnosed inthe US in 2009 and around 40,000 women were expected to die as a result ofbreast cancer·         Only lung cancer accounts for more cancer deaths among women.·         As many as 75% of breast cancer patients with metastatic disease willhave metastases in the bone (Harvey, H.A. and Cream, L.R. (2007) Clin. BreastCancer. Jul;7 Suppl 1:S7-S13) ###For further information, please contact Andrew Kay, CEO +47 2300 7990 / +47 4840 1360 (mob) Gillies O'Bryan-Tear, CMO +47 23 00 7824 / +47 4804 1411 (mob) ?stein Soug, CFO +47 2300 7990 / +47 9065 6525 (mob)   post(at)algeta.com International media enquiries: +44 207 638 9571 Mark Swallow/Helena Galilee/David mark.swallow(at)citigatedr.co.uk Dible Citigate Dewe Rogerson US investor enquiries: +1 646 378 2928 Jessica Lloyd jlloyd(at)troutgroup.com The Trout Group About AlgetaAlgeta ASA is a cancer therapeutics company built on world-leading, proprietarytechnology. Algeta is developing a new generation of targeted cancertherapeutics (alpha-pharmaceuticals) that harness the unique characteristics ofalpha 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 multiplemajor cancer types, owing to its bone-targeting nature, potent efficacy(therapeutic and palliative) and benign safety profile. Development ofAlpharadin is most advanced targeting bone metastases resulting fromhormone-refractory prostate cancer (HRPC), and it entered an international phaseIII clinical trial (ALSYMPCA) in mid-2008 based on compelling clinical resultsfrom a comprehensive phase II program. This trial is currently open forrecruitment.In September 2009, Algeta entered into a global agreement with Bayer HealthcareAG for the development and commercialization of Alpharadin. As part of theagreement, Algeta retains an option to co-promote Alpharadin in the UnitedStates and to share profits from future sales.Algeta is also developing other technologies for deliveringalpha-pharmaceuticals. These include methods to enhance the potency oftherapeutic antibodies and other tumor-targeting molecules by linking them tothe alpha particle emitter thorium-227. The Company is headquartered in Oslo,Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange inMarch 2007 (Ticker: ALGETA).Alpharadin and Algeta are trademarks of Algeta ASA.Forward-looking StatementThis news release contains forward-looking statements and forecasts based onuncertainty, since they relate to events and depend on circumstances that willoccur in the future and which, by their nature, will have an impact on resultsof operations and the financial condition of Algeta. There are a number offactors that could cause actual results and developments to differ materiallyfrom those expressed or implied by these forward-looking statements. Thesesfactors include, among other things, risks associated with technologicaldevelopment, the risk that research & development will not yield new productsthat achieve commercial success, the impact of competition, the ability to closeviable and profitable business deals, the risk of non-approval of patents notyet granted and difficulties of obtaining relevant governmental approvals fornew products.                                        ###--------------------------------------------------------------------------------[1] The following markers of bone turnover will be measured to follow the effectof Alpharadin during the 16-week treatment period: urine N-Telopeptide (uNTX),urine C-Telopeptide (uCTX-1), bone specific alkaline phosphatase (bALP),N-terminal propeptide of procollagen type 1 (P1NP), pyridinoline cross-linkedcarboxyterminal telopeptide (ICTP).This information is subject of the disclosure requirements acc. to §5-12 vphl(Norwegian Securities Trading Act)[HUG#1379309] Press release - Breast study: http://hugin.info/134655/R/1379309/339395.pdf

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