Hybrigenics raises dosage in inecalcitol study

Hybrigenics, a French biopharmaceutical company with a focus on cancer treatments, says that its domestic regulatory agency, the AFSSAPS, has authorized it to increase inecalcitol dosage in a Phase II trial currently underway in hormone-refractory prostate cancer.

Inecalcitol is a chemical analog of vitamin D and is being administered in the trial via daily oral doses in combination with French drug major Sanofi-Aventis' Taxotere (docetaxel), the gold-standard intravenous chemotherapy for this indication. The trial started six months ago in six cancer centers in France; so far, a total of 18 patients have been enrolled. At 40mcg, 80mcg and 160mcg per day for several weeks, no increases in calcium levels have been observed in blood or urine, the dose-limiting side effect of the natural derivatives of vitamin D, the firm noted.

As a result, Hybrigenics submitted an application to amend the Investigational Medicinal Product Dossier to the AFSSAPS to allow it to continue to double the dosage. Now the agency has accepted this application, the company will test the doses of 300mcg per day between June and September - and 600mcg per day from October until the end of 2008. The objective of this Phase II study is to determine the maximum tolerated daily oral dose of inecalcitol over an 18-week period.