Alpharadin found to be safe and easy to use in patients with bone metastases resulting from CRPC
Alpharadin found to be safe and easy to use in patients with bone metastases resulting from castration-resistant prostate cancer (CRPC)
Oslo, Norway, 3 November 2010 – Algeta ASA (OSE: ALGETA), the focused oncology company, presented yesterday an analysis based on clinical experience with Alpharadin from its phase I and phase II programs. The analysis concluded that Alpharadin is safe and easy to use, requires no specialized equipment and is convenient for patients. These data were presented in a poster at the 52nd annual meeting of the American Society for Radiation Oncology (ASTRO) in San Diego, USA.
Alpharadin (radium-223 chloride) is a first-in-class alpha-pharmaceutical with a potent, targeted effect on bone metastases and a highly tolerable side-effect profile in patients with bone metastases resulting from castration-resistant prostate cancer (CRPC).
The properties of Alpharadin were characterized to establish the radiation protection parameters for its safe use in the phase I and phase II clinical trials involving 292 patients, and the ongoing 900-patient phase III ALSYMPCA study.
Key among the properties described was the ultra-short penetration of alpha particles and the fact that alpha radiation is readily blocked, which allows for ease of handling of Alpharadin and no requirement for complex shielding during shipping and administration. Patients are treated as outpatients and can return to normal life immediately afterwards.
From a clinical perspective, the major benefit of alpha-pharmaceuticals is that the ultra-short range corresponds to a highly localized cytotoxic action in target areas containing bone metastases (effective range: 2-10 cell diameters). This localized effect spares surrounding healthy tissue and bone marrow and results in the favorable side-effect profile observed in the phase II clinical program: hematologic adverse events with Alpharadin were typically mild (CTC grades 1, 2) and transient, and not one patient withdrew due to hematologic toxicity.
Finally, Alpharadin is manufactured as a ready-to-use vial and the 11.4 day half-life allows a long shelf life of 28 days, enabling sufficient time for its distribution (including long-distance shipment) and administration to patients.
Gillies O’Bryan-Tear, Algeta’s CMO, commented: “Alpha-pharmaceuticals represent a truly new class of cancer therapeutic that produces a potent, localized therapeutic effect combined with a highly favourable side-effect profile. Our studies with Alpharadin have demonstrated that alpha-pharmaceuticals are easy to use for clinicians and convenient for patients, all of which gives us great confidence in the potential of alpha-pharmaceuticals to establish themselves in future regimes for cancer patients in need of new treatment options.”
For further information, please contact:
Andrew Kay, CEO
Gillies O’Bryan-Tear, CMO
Øystein Soug, CFO
+47 2300 7990 / +47 4840 1360 (mob)
+47 23 00 7824 / +47 4804 1411 (mob)
+47 2300 7990 / +47 9065 6525 (mob)
International media enquiries:
Mark Swallow/David Dible Citigate Dewe Rogerson +44 207 638 9571 email@example.com
The Trout Group
+1 646 378 2928
Algeta is a focused oncology company developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.
Algeta’s lead product Alpharadin (based on radium-223) is a first-in-class, highly targeted alpha-pharmaceutical under clinical evaluation to improve survival in patients with bone metastases from advanced cancer. Its localized action helps preserve the surrounding healthy tissue thereby limiting side-effects.
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 in up to 90% of certain late-stage cancers, e.g. prostate, breast and lung.
Alpharadin is being developed under a development and commercialization agreement with Bayer Schering Pharma AG, a major pharmaceutical company, and is in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from castration-resistant prostate cancer (CRPC). Alpharadin is also under investigation in phase II clinical trials as a potential new treatment for bone metastases in endocrine-refractory breast cancer patients, and in a phase I/IIa trial in combination with docetaxel chemotherapy in for bone metastases CRPC patients.
Algeta also aims to develop a future pipeline of tumor-targeting alpha-pharmaceutical candidates based on the alpha particle emitter thorium-227, through selective in-licensing and/or acquiring innovative technologies and tumor-targeting molecules.
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.
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.
Mark Swallow, Ph.D. Citigate Dewe Rogerson
+44 (0)20 7282 2948 (direct) +44 (0)7903 737703 (mobile) +44 (0)20 7638 9571 (switchboard) +44 (0)20 7282 2811 (fax)
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Posted: November 2010