New clinical analyses from Alpharadin clinical programs to be presented at 2010 Genitourinary Cancers Symposium

Posted on: Fri, 05 Mar 2010 06:01:17 EST


Symbols: ALGZF
Mar 05, 2010 (Hugin via COMTEX) --

Findings support Alpharadin is specifically targeted to bone metastases and has a highly favorable safety profile

Oslo, Norway, 5 March 2010 - Algeta ASA (OSE: ALGETA), the focused oncology company, announces that analyses of clinical data from new and previous studies in its phase I and phase II clinical programs with Alpharadin will be presented at the 2010 Genitourinary Cancers Symposium* in San Francisco, CA, USA (5-7 March 2010).

Alpharadin (radium-223 chloride), being developed by Algeta and Bayer Schering Pharma AG, is a first-in-class alpha-pharmaceutical that has a potent and highly targeted antitumor effect on bone metastases combined with a highly favorable side-effect profile. In Phase II trials, Alpharadin showed a statistically significant improvement in overall survival compared to placebo. Alpharadin is currently in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from hormone-refractory (castration-resistant) prostate cancer (HRPC). Bone metastases are the main cause of disability and death in patients with HRPC and approximately 90% of men with this disease have radiological evidence of bone metastasis.

Presentations describing two new studies and an analysis of overall safety data from the Alpharadin phase I and II clinical program will be made at the meeting by leading cancer specialists involved in the program.

Details of the posters are as follows (and copies will available from www.algeta.com):

Abstract No. 106 - A combined safety analysis of data from all 292 men with bone metastases resulting from HRPC who received Alpharadin in the phase I and phase II trials. This analysis confirmed that Alpharadin was eliminated rapidly from blood with uptake in the bone metastases and rapid excretion into the small intestine with no hepatobiliary excretion, and very little or no uptake in kidneys, liver and other internal organs.In the placebo-controlled phase II BC1-02 study (31 receiving placebo and 33 receiving Alpharadin) there were more adverse events in the placebo group than in the Alpharadin group (174 vs 155), and more serious adverse events in the placebo group (19 vs 12). No signs of renal or hepatic toxicity were seen.

The poster will be presented by Prof. Sten Nilsson (Karolinska Hospital, Stockholm, Sweden). Date /Time: 5 March 2009, from 16.45 to 18.00 hrs (PST) Session: General Poster Session B: Prostate Cancer Location: Golden Gate Hall

Abstract No. 216A - Analysis of biodistribution and dosimetry data from phase I trial (BC1-05) following administration of Alpharadin in men with bone metastases resulting from HRPC. The analysis showed that Alpharadin was rapidly and specifically taken up by bone and that the remainder was rapidly excreted predominantly through the gastrointestinal tract. The localization of Alpharadin to bone metastases combined with its emission of very short-range alpha radiation may account for the highly favorable safety profile observed in phase I and II studies.

The poster will be presented by Dr. Chris Parker (Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK) Date /Time: 6 March 2009, from 12.30 to 14.00 hrs (PST) Session: General Poster Session C: Prostate cancer Location: Golden Gate Hall

Abstract No. 211 - Analysis of data from phase I pharmacokinetic and biodistribution study (BC1-08) with escalating doses of Alpharadin in men with bone metastases resulting from HRPC. The study found that Alpharadin rapidly cleared the blood and accumulated in bone metastases within 10 minutes of injection. Alpharadin was also seen in the small bowel within the same timeframe, with subsequent excretion in the feces.

The poster will be presented by Dr. Michael Morris (Memorial Sloan-Kettering Cancer Center, New York, USA) Date /Time: 6 March 2009, from 12.30 to 14.00 hrs (PST) Session: General Poster Session C: Prostate Cancer Location: Golden Gate Hall

*The 2010 Genitourinary Cancers Symposium is being co-sponsored by three leading medical specialty societies, including the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO).

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For further information, please contact

For Algeta:

Andrew Kay, CEO +47 2300 7990 / +474840 1360 (mob) Gillies O'Bryan-Tear, CMO +47 23 00 7824 / +47 4804 1411 (mob) Oystein Soug, CFO +47 2300 7990 / +479065 6525 (mob) post@algeta.com

International media enquiries: +44 207 638 9571 Mark Swallow/Helena Galilee/David mark.swallow@citigatedr.co.uk Dible <mailto:mark.swallow@citigatedr.co.uk> Citigate Dewe Rogerson

US investor enquiries: +1 646 378 2928 Jessica Lloyd jlloyd@troutgroup.com The Trout Group <mailto:jlloyd@troutgroup.com>

For Bayer Schering Pharma:

David Freundel +1 (973) 305-5310 david.freundel@bayer.com <mailto:david.freundel@bayer.com>

About Algeta

Algeta is a focused oncology company developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.

Algeta's lead product Alpharadin (based on radium-223) is a first-in-class, highly targeted alpha-pharmaceutical under clinical evaluation to improve survival in patients with bone metastasesfrom advanced cancer. Its localized action helps preserve the surrounding healthy tissue thereby limiting side-effects.

The development of bone metastases represents a serious development for cancer patients as they are associated with a dramatic decline in patient health and quality of life, ultimately leading to death. Bone metastases represent a major unmet medical need, occurring in up to 90% of certain late-stage cancers, e.g. prostate, breast and lung.

Alpharadin is partnered with Bayer Schering Pharma AG, a major pharmaceutical company, and is in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from hormone-refractory (castration-resistant) prostate cancer. Alpharadin is also under investigation in phase II clinical trials as a potential new treatment for bone metastases in endocrine-refractory breast cancer patients.

Algeta also aims to develop a future pipeline of tumor-targeting alpha-pharmaceutical candidates based on the alpha particle emitter thorium-227, through selective in-licensing and/or acquiring innovative technologies and tumor-targeting molecules.

The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).

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.

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This information is subject of the disclosure requirements acc. to 5-12 vphl (Norwegian Securities Trading Act)

[HUG#1391282]

Press release: http://hugin.info/134655/R/1391282/349179.pdf

SOURCE: Algeta ASA

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