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news.Hybrigenics' daily oral Inecalcitol in combination with gold standard Taxotere chemotherapy demonstrated positive results in hormone-refractory prostate cancer patients in a Phase IIa study.
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In the study it was observed that the maximal tolerated dose of Inecalcitol is 4mg per day and the response rate to combination treatment reached 85% based on Prostate-Specific Antigen (PSA) decline within 3 months.
Hybrigenics said that based on the safety profile and 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.
Out of 52 patients treated up to 4mg per day, 47 were evaluable by PSA monitoring and 40 patients showed more than 30% decrease in PSA levels within three months.
Overall, the 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.