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Hybrigenics Starts Phase II Clinical Trial of Inecalcitol in CLL

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Hybrigenics (ALHYG) has announced the start of a phase II 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 enrol 50 CLL patients, initially across six centres 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 immuno-chemotherapy but at high risk of disease progression.

Depending on enrolment 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.

Dr. Dufour-Lamartinie continued, "Additional centers could therefore be opened in the next few months in order to speed up patient enrolment."

"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."