Oslo, Norway, 9 December 2011 - Algeta ASA (OSE: ALGETA) announces that positive results from the phase IIa BC1-09 clinical study evaluating Alpharadin (radium-223 chloride) in endocrine-refractory breast cancer patients with bone metastases were presented in a poster today at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium (San Antonio, TX, USA).
These results confirm the positive preliminary results announced by Algeta and Bayer Pharma AG in June 2011.
Analysis of the trial data found that Alpharadin treatment met the co-primary endpoints by significantly reducing the levels of bone alkaline phosphatase (bALP), and urine N-telopeptide (uNTX) during the 16-week treatment period in breast cancer patients with bone metastases receiving bisphosphonates. These parameters are used as key markers of bone involvement in breast cancer.
Median uNTX levels were reduced by 20% (from 36 to 29 nmolBCE/mmol creatinine; p=0.0164) and by 33% (from 36 to 24 nmolBCE/mmol creatinine; p=0.0201), at weeks 8 and 16, respectively; 17/23 and 13/16 patients had a decrease in uNTX at weeks 8 and 16, respectively.
Median bALP levels were reduced by 45% (from 22.1 to 12.1 ng/mL; p=0.001) at week 8 and by 51% (from 22.1 to 10.9 ng/mL; p=0.0045) at week 16; bALP levels were reduced in 20/22 patients at week 8 and in 14/16 patients at week 16.
Alpharadin was also found to be safe and well-tolerated in the study, confirming the well-tolerated side effect profile seen in other studies. Three patients reported serious adverse events, although none of these events was deemed to be related to the study drug.
Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "These results are encouraging for patients with bone metastases in breast cancer, who do not always respond well to current treatments. They follow the exciting positive phase III results we have seen in prostate cancer patients with bone metastases, suggesting that Alpharadin may have potential in treating bone metastases across multiple cancer indications. We look forward to further trials to confirm this."
Prof. Robert Coleman, a cancer specialist at the Weston Park Hospital in Sheffield and Principal Investigator for the trial, said: "Bone metastases cause significant distress for patients and may respond poorly to current modalities of treatment. We are encouraged that Alpharadin has shown efficacy against key markers of bone disease in these breast cancer patients. If Alpharadin can show positive results in larger trials in breast cancer, then it may become an important new therapy for women with limited treatment options."
The poster (number P4-16-04, abstract 41.035, Coleman, et al.) was entitled "An open-label, phase IIa, non-randomized study of radium-223 in breast cancer patients with bone dominant disease no longer considered suitable for endocrine therapy." The poster will be available at www.algeta.com
BC1-09 trial design
The study included metastatic breast cancer patients with bone-dominant disease who had progressed (based on imaging or other clinically relevant information) on endocrine therapy and were no longer considered suitable for endocrine therapy. In this open-label, multicenter, single-arm, phase IIa study, 23 patients were scheduled to receive four intravenous injections of radium-223 chloride 50 kBq/kg every four weeks. Bone markers were assessed at baseline, prior to every treatment, and thereafter at each follow-up visit. The co-primary efficacy endpoints were changes from baseline in urine levels of N-telopeptide (uNTX) and bone alkaline phosphatase (bALP) at 16 weeks. Functional imaging with FDG-PET was performed in 20 patients at baseline and weeks 8 and 16. Symptomatic response was assessed using validated questionnaires (data not available yet).
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For further information, please contact
| Algeta ASA: | |
| Mike Booth Communications & Corporate Affairs | +47 2202 4510 ir@algeta.com (mailto:ir@algeta.com) |
| International media enquiries: Mark Swallow Citigate Dewe Rogerson | +44 207 638 9571 mark.swallow@citigatedr.co.uk (mailto:mark.swallow@citigatedr.co.uk) |
| US investor enquiries: Jessica Lloyd The Trout Group | +1 646 378 2928 jlloyd@troutgroup.com (mailto:jlloyd@troutgroup.com) |
About Algeta
Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.
Algeta's lead product Alpharadin (radium-223 chloride) is a first-in-class, highly targeted alpha-pharmaceutical under clinical evaluation to improve survival in patients with advanced forms of cancer and bone metastases. Its localized action helps preserve the surrounding healthy tissue thereby limiting side-effects.
Alpharadin is being developed under a development and commercialization agreement with Bayer Pharma AG. In June 2011, a global phase III clinical trial (ALSYMPCA) of Alpharadin to treat castration-resistant prostate cancer (CRPC) patients with symptomatic bone metastases was stopped early after meeting its primary endpoint of significantly improving overall survival. The US Food and Drug Administration (FDA) granted Alpharadin Fast Track designation for this indication. Alpharadin is also in clinical development as a potential new treatment for breast cancer patients with bone metastases, and is in a phase I/IIa trial in combination with docetaxel chemotherapy in CRPC patients with bone metastases.
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 frequently in certain late-stage cancers, e.g. prostate (in up to 90% patients), breast (up to 80%) and lung (up to 40%).
Algeta is also exploring the potential of Targeted Thorium Conjugates (TTCs), which are based on conjugating the alpha-emitter thorium-227 to targeting molecules, as a basis of a future pipeline of tumor-targeting alpha-pharmaceutical candidates.
The Company is headquartered in Oslo, Norway, and is listed on the Oslo Stock Exchange (Ticker: ALGETA).
Alpharadin and Algeta are trademarks of Algeta ASA.
Forward-looking Statements
This news release contains certain forward-looking statements 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. Such forward-looking statements reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance to the correctness of such statements. 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. These factors include, among other things, risks or uncertainties associated with the success of future clinical trials, collaborations with other companies in the development of targeting molecules and alpha particle payloads, risks associated with technological development, the ability to successfully commercialize Alpharadin and our other products, the risk that research & development will not yield new products that achieve commercial success, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for Alpharadin and our other products and difficulties of obtaining relevant governmental approvals for new products, and the other risks and uncertainties described in our annual report.
Press release (http://hugin.info/134655/R/1570294/488253.pdf)
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Source: Algeta ASA via Thomson Reuters ONE
