Alpharadin found to be safe and easy to use in patients with bone metastases resulting from castration-resistant prostate cancer
Algeta ASA presented 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 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.
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