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Algeta ASA (OSL:ALGETA) Oslo, Norway, 12 August 2008 - Algeta ASA (OSE: ALGETA), the cancer therapeutics company, has started the first US clinical trial for its lead product Alpharadin in men with hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton.
The new US trial (BC1-08) will be a phase I open label, ascending dose study of Alpharadin (radium-223 chloride) in up to 18 HRPC patients and will be conducted at the Memorial Sloan-Kettering Cancer Center (MSKCC) in New York. The trial will evaluate the pharmacokinetics and biodistribution of Alpharadin in relation to dose and will further expand the information obtained in a similar phase I study (BC1-05), which completed earlier this year. Each patient will be administered a single intravenous injection of Alpharadin and the activity will be measured in the whole body and regions of interest, including the skeleton and the sites of bone metastases. The first group of patients will receive a dose of 50 kBq/kg, the next 100 kBq/kg, and the final group will receive 200 kBq/kg body weight (0.0014, 0.0027 and 0.0054 mCi/kg).
The principal investigator of the US trial at MSKCC, Michael Morris M.D., said: "We are looking forward to introducing this promising new therapy option to US patients".
The earlier BC1-05 study confirmed that Alpharadin is rapidly taken up in the bone, the primary site of its therapeutic action, and any that is not taken up by the bone is rapidly excreted from the body, mainly via faeces. There was no specific uptake in normal organs such as the kidneys or the liver resulting in very low absorbed doses to these organs. The patients received two intravenous injections of Alpharadin at a therapeutic dose of 100 kBq/kg body weight six weeks apart and the results were similar after both injections. The results confirm the safety and benign side-effect profile of Alpharadin.
Dr. Thomas Ramdahl, President and CEO of Algeta, said: "We are delighted to begin this important US trial with Alpharadin and to be working with the MSKCC, one of the world's leading cancer centers. The start of this US clinical trial is an important step in our overall clinical development of Alpharadin and we hope it will lead the way towards more widespread evaluation of Alpharadin in US cancer centers after further discussions with FDA later this year."
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For further information, please contact
Dr. Thomas Ramdahl, CEO +47 23 00 79 90 / +47 913 91 458 (mob) Øystein Soug, CFO +47 23 00 79 90/ +47 906 56 525 (mob) post@algeta.com
Dr. Mark Swallow / David Dible +44 (0)207 638 9571 Citigate Dewe Rogerson mark.swallow@citigatedr.co.uk
About Alpharadin and the ALSYMPCA study
Alpharadin (radium-223 chloride) is a unique targeted therapeutic in phase III clinical trials for the treatment for hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton. Phase II clinical data show that Alpharadin increased the survival of men with HRPC by 40%, and was extremely well-tolerated with a benign side-effect profile. Alpharadin treatment affected blood levels of several biomarkers indicative of a positive therapeutic effect, such as reduction of PSA (prostate-specific antigen) levels, and induced significant changes in a panel of makers of bone metabolism. Alpharadin is convenient to use and is administered by intravenous injection on an outpatient basis.
The ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study is a phase III double-blind, controlled trial enrolling men with HRPC that has metastasized to the skeleton, who will be randomized to receive Alpharadin plus best standard of care or placebo plus best standard of care. Approximately 750 patients are expected to be enrolled at more than 125 medical centers in Europe, Asia, South America and Canada.
The primary efficacy endpoint of the ALSYMPCA trial is overall survival. Patients will be randomized 2-to-1 in favor of Alpharadin, which will be given as six injections of 50 kBq/kg body weight, four weeks apart. Secondary endpoints include time to occurrence of specified disease-related events, and time to progression of certain key biomarkers indicative of disease status, including blood levels of serum PSA and total alkaline phosphatase (ALP). In addition, the trial will monitor and evaluate both the acute and long-term safety profiles of Alpharadin treatment as well as its impact on quality of life.
Physicians interested in referring a qualified patient may go to www.algeta.com for further information about the study.
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, has commenced a phase III clinical trial (ALSYMPCA) in men with hormone-refractory prostate cancer with confirmed skeletal metastases. 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.
