The trial is being carried out in 30 hormone refractory prostate cancer patients with bone metastases in clinical centers in the US and several European countries. This study aims to show that the Orazol weekly tablet has a similar therapeutic effect to the currently marketed IV infusion, as measured by the biomarkers of osteolysis.
Orazol is Merrion’s lead product indicated for the treatment of bone metastases secondary to several types of cancer. Orazol is a weekly tablet form of zoledronic acid, which currently has only been available as an IV infusion (Zometa, Novartis).
John Lynch, CEO of Merrion, said: “The completion of enrollment in this Orazol Phase IIb study is another significant milestone for Merrion. Once the dosing is complete, we will analyze and announce the data. Then we will look to license Orazol to a suitable partner who will complete the product development, file registration and market this product, which we believe has significant potential.”