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Algeta ASA Oslo, Norway, 18 June 2008 - Algeta ASA (OSE: ALGETA), the cancer therapeutics company, has started patient recruitment in a pivotal phase III clinical study of its targeted therapeutic Alpharadin in advanced, hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton. This development follows the publication of phase II results showing that Alpharadin treatment provides a significant survival benefit in metastatic HRPC patients compared to placebo.
The ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study is a double-blind, randomised, controlled trial that enrols symptomatic HRPC patients 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 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 prostate-specific antigen (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.
The Co-ordinating Investigator for the ALSYMPCA study is Dr. Christopher Parker, a leading clinical oncologist and specialist in prostate cancer based at the Institute of Cancer Research and the Royal Marsden Hospital in Sutton, UK.
Dr Parker commented: "Today the treatment of men with bone metastases is largely aimed at pain relief. There is an urgent need for an effective, bone-targeted treatment that prolongs survival, and I am delighted to be able to participate in the clinical development program of Alpharadin."
Physicians interested in referring a qualified patient may go to www.algeta.com for further information about the study.
"We are very pleased to get this important phase III trial underway," said Dr. Thomas Ramdahl, President and CEO of Algeta. "The compelling results, including a positive survival benefit, we have seen in patients treated with Alpharadin in our phase II trial together with a benign side effect profile give us confidence that Alpharadin has the potential to become an important treatment option for patients with advanced prostate and other cancers that metastasise to the skeleton. This new phase in the clinical development of Alpharadin marks another significant milestone for Algeta and represents an important step in the evolution of the company."
About Alpharadin Alpharadin is a unique targeted treatment for skeletal metastases in cancer patients formulated from a salt of radium-223. Phase II clinical data show that Alpharadin can significantly increase life expectancy in men with HRPC, and also are suggestive of a role in certain other high-incidence cancers.
The clinical data from the phase II trial involving 64 HRPC patients showed that more than twice as many patients receiving Alpharadin were alive (10 out of 33) two years following the start of treatment than were those that received placebo (4 out of 31). Alpharadin is conveniently administered as a monthly, intravenous bolus injection in an out-patient setting. Patients in the phase II trial received regular injections over four months and the treatment was well tolerated with a benign side-effect profile. These encouraging data were presented during 2007 at leading international congresses, such as ASCO and ECCO, and were published in Lancet Oncology (Ref. 1).
About Prostate Cancer and Bone Metastases According to Cancer Research UK, more than 670,000 men are diagnosed with prostate cancer each year with around 300,000 new cases being diagnosed each year in Europe. The highest rates are in the USA and Sweden whilst the lowest rates are in China and India.
There is no effective therapeutic for treating established bone metastases and there is an urgent need for novel treatments which prolong life.
Bone is the most common organ to be affected by metastatic cancer (Ref. 2). Approximately 1.5 million cancer patients suffer from bone metastases worldwide and there are some 300,000 new cases each year. Importantly, metastases may stay confined to the skeleton with subsequent morbidity and eventual death almost entirely due to skeletal complications and their treatment.
Some 80% of metastatic bone metastases are due to prostate and breast carcinomas. For these high incidence cancers, 65-75% patients with advanced disease will have bone metastases (Ref. 3). They may suffer multiple skeletal complications over several years because the clinical course of metastatic bone disease is relatively long. The effects are often debilitating (intractable bone pain, fractures, hypercalcaemia, and spinal cord compression) and profoundly impair a patient's quality of life.
Bone metastases also occur frequently in patients with lung, kidney and thyroid cancers - respectively in 30-40%, 20-25% and 60% of patients with advanced disease.
Current treatments for skeletal metastases are largely palliative. They include opioid analgesics, external beam radiotherapy, beta-emitting radio-nuclides, and bisphosphonate bone resorption inhibitors. The bisphosphonates also have a role in adjuvant treatment to reduce the incidence of bone lesions.
References 1. Nilsson, S. et al. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncology 2007; 8(7): 587-594 2. Coleman, R.E. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006;12:6243s-6249s. Review 3. Rubens, R.D, and Coleman, R.E. Bone Metastases. In: Abaloff, M.D., Armitage, J.O., Lichter, A.S. and Niederhuber, J.E. Clinical Oncology 1995: 643-665
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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 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 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.
