Authorisation to Dose Prostate Cancer Patients Twice Daily with Oral Inecalcitol

Bio-pharmaceutical company Hybrigenics, announced that the French drug agency, AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé), approved an amendment to the current clinical tolerance Phase IIa study in hormone-refractory prostate cancer patients. The amendment allows the 4mg oral dose of inecalcitol to be tested once- and twice-a-day. Excellent tolerance has been observed at the dose of 2mg per day for 18 weeks in 6 additional patients since August 2009 with no sign of hypercalcemia, the usual dose-limiting toxicity of vitamin D analogues.

As a result, the dose can now be increased to 4mg per day. In addition, based on the favourable pharmacokinetics of inecalcitol, which does not accumulate in the body, the twice-daily regimen (every 12 hours) will be tested for a more frequent exposure of the tumor to the cytostatic activity of inecalcitol. "A twice-daily regimen is very innovative for a vitamin D agonist such as inecalcitol," said Dr Jean-François Dufour-Lamartinie, Hybrigenics’ Head of Clinical R&D. "It will increase the probability that it will prove efficacious in cancer indications where tumour drug exposure is key to therapeutic success."