OSLO, December 11 Algeta ASA (OSE: ALGETA), thecancer therapeutics company, announces that the first clinical center in theUS, the Tulane Cancer Center, New Orleans, has started randomizing patientsin the phase III clinical study of Alpharadin in men withcastration-resistant (also known as hormone-refractory) prostate cancer(CRPC) that has metastasized to the skeleton.
The ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study is adouble-blind, randomized, controlled trial that enrols patients with CRPC andsymptomatic bone metastases who will be randomized to receive Alpharadin(radium-223 chloride) plus best standard of care or placebo plus beststandard of care. Approximately 750 patients are expected to be enrolled atmore than 125 medical centers worldwide. Algeta expects to enroll patientsacross up to 15 sites in the US. Global recruitment remains on schedule andis expected to be complete by the second half of 2010.
The Principal Investigator of the ALSYMPCA study in the US is Dr. OliverSartor, Piltz Professor of Cancer Research in the Departments of Medicine andUrology at Tulane University School of Medicine at the Tulane Cancer Centerin New Orleans. The Tulane Cancer Center is one of the top cancer-focusedmedical centers in the US.
Dr. Sartor is an internationally recognized medical oncologist with aninterest in prostate cancer from both a basic research and clinicalperspective. He is chair-elect of the US Department of Defense ProstateCancer Integration Panel and is co-editor-in-chief of the peer-reviewedjournal Clinical Genitourinary Cancer. He is also the current medicaloncology chair of the Genitourinary Cancer Committee of the RadiationOncology Treatment Group, a leading US multicenter research organizationtesting novel radiotherapy approaches against cancer.
Dr Sartor commented: "Alpharadin works by targeting and destroying cancercells in the bone while sparing healthy bone marrow tissue. If successful inclinical trials, this compound could make a significant difference for thelarge number of men whose cancer has spread to the bones. Patients most oftendie as a consequence of the metastases - not the primary cancer - sopreventing cancer from spreading and controlling cancer that has spread is amajor clinical challenge."
Physicians interested in referring a qualified patient may go tohttp://www.algeta.com for further information about this study.
Andrew Kay, Algeta's President and CEO said: "We are pleased to begin theALSYMPCA phase III study in the US and especially excited to be working withDr. Sartor, an internationally recognized prostate cancer expert at theTulane Cancer Center, one of the world's leading cancer hospitals. Theenrolment of patients into US clinical centers is an important step in theoverall clinical development of Alpharadin and we expect further US clinicalcenters to come online in the coming months."
In September, Algeta signed a USD 800 million agreement with BayerSchering Pharma AG for the development and global commercialization ofAlpharadin.
Algeta ASA is a cancer therapeutics company built on world-leading,proprietary technology. Algeta is developing a new generation of targetedcancer therapeutics (alpha-pharmaceuticals) that harness the uniquecharacteristics of alpha particle emitters and are potent, well-tolerated andconvenient to use.
Algeta's lead alpha-pharmaceutical candidate, Alpharadin (based onradium-223), has blockbuster potential for treating bone metastases arisingfrom multiple major cancer types, owing to its bone-targeting nature, potentefficacy (therapeutic and palliative) and benign safety profile. Developmentof Alpharadin is most advanced targeting bone metastases resulting fromhormone-refractory prostate cancer (HRPC), and it entered an internationalphase III clinical trial (ALSYMPCA) in mid-2008 based on compelling clinicalresults from a comprehensive phase II program. This trial is currently openfor recruitment.
In September 2009, Algeta entered into a global agreement with BayerHealthcare AG for the development and commercialization of Alpharadin. Aspart of the agreement, Algeta retains an option to co-promote Alpharadin inthe United States 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.
This news release contains forward-looking statements and forecasts basedon uncertainty, since they relate to events and depend on circumstances thatwill occur in the future and which, by their nature, will have an impact onresults of operations and the financial condition of Algeta. There are anumber of factors that could cause actual results and developments to differmaterially from those expressed or implied by these forward-lookingstatements. Theses factors include, among other things, risks associated withtechnological development, the risk that research & development will notyield new products that achieve commercial success, the impact ofcompetition, the ability to close viable and profitable business deals, therisk of non-approval of patents not yet granted and difficulties of obtainingrelevant 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) [email protected]
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