Hybrigenics, a bio-pharmaceutical company with a focus on research and development of new treatments against proliferative diseases, announces the start of a Phase 2 clinical trial of oral inecalcitol in patients with chronic lymphocytic leukemia (CLL). World-wide, about 130,000 new patients are diagnosed each year with CLL, for which there is currently no definitive cure. CLL is designated as an orphan disease in the United States, Europe and Japan.

The study will enroll 50 CLL patients, initially across six centers in France, and be coordinated by Prof. Hermine, head of clinical haematology at Necker Hospital in Paris, with the endorsement and active participation of the French Cooperative Group on CLL. It is an open-label trial assessing the safety and potential efficacy of inecalcitol given to CLL patients not yet requiring immunochemotherapy but at high risk of disease progression. Depending on enrollment speed, this study should last until end of 2013 or beyond. Funding of this clinical trial has been secured by a EUR 3.3 million PIPE in March this year. The first two patients have received their first treatments.

Inecalcitol is given orally at two milligrams per day for at least six months or until progression occurs. The objectives are to decrease or stabilize the number of blood-circulating CLL cells and to delay the onset of other signs of progression, such as swelling of lymph nodes and thereby the need for immuno-chemotherapy.

"The clinical trial of oral inecalcitol in CLL has started as planned. We are very satisfied with the level of interest in this study generated among the French CLL specialists," said Dr. Jean-Francois Dufour-Lamartinie, head of clinical R&D. "Additional centers could therefore be opened in the next few months in order to speed up patient enrollment."

"This trial could stand out as important for CLL patients because treatment with inecalcitol would provide their first therapeutic alternative prior to chemotherapy," said Remi Delansorne, Hybrigenics' CEO. "This study would also bring about the first clinical proof of concept of inecalcitol as a single therapeutic agent."

Date: September 11, 2012
Source: Hybrigenics