Hybrigenics Receives Authorization to Accelerate Inecalcitol Dose Escalation in Phase II Trial
News Jun 26, 2008
Hybrigenics has announced that France's regulatory agency AFSSAPS has authorized the company to increase inecalcitol dosage in Hybrigenics' Phase II clinical trial currently underway for patients suffering from hormone-refractory prostate cancer.
Inecalcitol is a chemical analogue of vitamin D and is being administered in the trial via daily oral doses in combination with Taxotere® (Sanofi-Aventis), 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 40, 80 and 160 micrograms 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.
As a result, Hybrigenics submitted an application to amend the Investigational Medicinal Product Dossier (IMPD) to AFSSAPS to allow it to continue to double the dosage.
Now AFFSAPS has accepted this application, Hybrigenics will test the doses of 300 micrograms per day between June and September - and 600 micrograms 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.