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Hybrigenics Unveils Final Results of inecalcitol Phase IIa Clinical Study in Hormone-Refractory Prostate Cancer


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Hybrigenics announces the positive outcomes of clinical tolerance Phase IIa study of daily oral inecalcitol in combination with gold standard Taxotere® chemotherapy in hormone-refractory prostate cancer patients. The maximal tolerated dose of inecalcitol is 4 milligrams (mg) per day and the response rate to combination treatment reached 85 per cent based on Prostate-Specific Antigen (PSA) decline within 3 months.

Given its excellent safety profile and strong presumption of efficacy, inecalcitol can proceed to clinical efficacy Phase IIb study in the same therapeutic indication. Other diseases such as hormone-dependent prostate cancer, severe psoriasis or hyperparathyroidism resulting from chronic kidney disease, are also being considered as additional indications of daily oral inecalcitol.

The levels of parathyroid hormone (parathormone), a hormone involved in the physiological regulation of calcium levels, were markedly depressed by inecalcitol at the dose of 4 mg per day. There is a condition called “hyperparathyroidism” in which parathormone levels are increased as a result of chronic kidney disease. Other vitamin D analogues such as paricalcitol and doxercalciferol are already widely prescribed in this indication to normalize parathormone levels. This new observation at the maximal tolerated dose of inecalcitol opens another therapeutic field worth exploring.

Overall, the excellent safety profile of inecalcitol by the oral route now allows its use in diseases where tolerance criteria are more stringent than for hormone-refractory prostate cancer: hormone-dependent prostate cancer, hyperparathyroidism, and also severe psoriasis.
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