Press Release.
Algeta presents new Phase II clinical trial data at ECCO
Oslo, Norway, 25 September 2007 – Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, today presents new two-year survival data from its Phase II clinical trial with Alpharadin (radium-223) as a treatment for hormone refractory prostate cancer (HRPC).
The new clinical data from the Phase II trial involving 64 HRPC patients shows that more than twice as many patients receiving Alpharadin were alive (10 of 33) two years following start of treatment compared to those that receive placebo (4 of 31).
Previous data from the trial, presented earlier this year at ASCO and in the Lancet Oncology[1], has also shown that Alpharadin significantly reduces levels of prostate-specific antigen (PSA), a widely recognized biomarker for progression of prostate cancer, and other relevant biomarkers. The treatment regime of four injections of Alpharadin was well tolerated during the 12-week treatment period, and an extended treatment period may further delay disease progression.
Algeta’s CEO, Dr. Thomas Ramdahl said: “Alpharadin continues to demonstrate a very positive clinical effect in the treatment of prostate cancer and our preparations to begin pivotal Phase III trials with Alpharadin for the treatment of HRPC in 2008 remain on schedule.”
The clinical data will be presented today in a poster for the first time in Europe at the 14th European Cancer Conference (“ECCO 14”: 23–27 September 2007, Barcelona, Spain). A copy of the poster, entitled Placebo-Controlled, Randomized, Phase II study of Radium-223 in Metastatic Hormone Refractory Prostate Cancer (HRPC), is available at http://www.algeta.com/
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For further information, please contact
Dr. Thomas Ramdahl, CEO
+47 23 00 79 90 / +47 913 91 458 (mob)
post@algeta.com
Dr. Mark Swallow / Helena Galilee
Citigate Dewe Rogerson +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk
About Algeta:
Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology.
Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.
Algeta’s lead product candidate, Alpharadin, is expected to enter Phase III clinical trials in hormone refractory prostate cancer based on positive Phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.
Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.
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.
[1] Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study – Lancet Oncology 2007; 8: 587-594