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Algeta to Enroll US Patients Into Global Phase III ALSYMPCA Trial Following Successful End-of-Phase II Meeting With FDA


2/3/2009 8:29:22 AM

OSLO, Norway, February 3 /PRNewswire-FirstCall/ --

- ALSYMPCA Study Designed to Evaluate Alpharadin for the Treatment of Bone Metastases in Prostate Cancer Patients

Algeta ASA , the cancer therapeutics company, announces that it is to enroll US patients into its ALSYMPCA phase III trial evaluating Alpharadin as a new treatment for bone metastases in patients with hormone-refractory prostate cancer (HRPC). This decision follows a successful end-of-phase II meeting* with the US Food and Drug Administration (FDA), held on 30 January 2009.

Algeta began enrolling patients for its global phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study in June 2008 and aims to enroll approximately 750 HRPC patients with bone metastases. Recruitment of US patients into the study is now planned to commence this year.

Alpharadin (radium-223) is Algeta's lead clinical candidate and has demonstrated in phase II studies strong evidence that it can prolong patient survival times, improves quality of life and offers a placebo-like safety profile.

These exciting clinical results combined with Alpharadin's unique bone-targeting properties highlight the potential of this novel cancer therapeutic to be an important new treatment for bone metastases that frequently arise from a number of high incidence cancers as well as HRPC (e.g. breast, lung and kidney). Bone metastases are a serious consequence of certain advanced cancers causing intractable and debilitating pain as well as further reducing life expectancy.

Andrew Kay, Algeta's President and CEO, said: "Our recent and previous discussions with FDA have been productive and we believe they have contributed positively to the overall clinical development plan for Alpharadin. We are therefore extremely pleased to enroll US patients into our pivotal ALSYMPCA study following the successful end-of-phase II meeting with the FDA. We will be focusing on initiating the study at key clinical centers in the US over the coming months."

ALSYMPCA phase III clinical study

The ALSYMPCA study is a double-blind, randomized, controlled trial that enrolls symptomatic HRPC patients who will be randomized to receive Alpharadin plus best standard of care or placebo plus best standard of care.

The primary efficacy endpoint of the trial is overall survival. Patients are being 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.

For more information on the ALSYMPCA trial, please go to http://www.algeta.com and click on the ALSYPMCA link in the menu bar.

About Algeta

Algeta ASA is a 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 (based on radium-223), has blockbuster potential for treating bone metastases arising from multiple major cancer types, owing to its bone-targeting nature, potent efficacy (therapeutic and palliative) and benign, placebo-like safety profile. Development of Alpharadin is most advanced targeting bone metastases resulting from hormone-refractory prostate cancer (HRPC), and it entered an international phase III clinical trial (ALSYMPCA) in mid-2008 based on compelling clinical results from a comprehensive phase II program.

Algeta's strategy is to launch Alpharadin as a first or second line treatment for cancer patients with bone metastases either alone or in combination with current standard of care therapies, thereby maximizing its commercial potential.

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 .

Alpharadin and Algeta are trademarks of Algeta ASA.

About Bone Metastases

Bone is the most common organ to be affected by metastatic cancer (Ref. 1). 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 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. 2). 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 radionuclides and bisphosphonates.

References

1. Coleman, R.E. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006;12:6243s-6249s. Review

2. 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

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.

---------------------------------

* The purpose of an end-of-phase II meeting is to determine the safety of proceeding to Phase III, to evaluate and the adequacy of current studies and plans to assess safety and effectiveness, and to identify any additional information necessary to support a marketing application for the uses under investigation.

CONTACT: For further information, please contact: Andrew Kay, President &
CEO, +47-23-00-67-42 / +47-48-40-13-60 (mob) or 0ystein Soug, CFO,
+47-23-00-79-84 / +47-906-56-525 (mob), post@algeta.com. For international
enquiries: Dr. Mark Swallow / David Dible / Helena Galilee, Citigate Dewe
Rogerson, +44-207-638-9571 / +44-7903-737703, mark.swallow@citigatedr.co.uk


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