Clinical Trials

* On July 16, 2014, Hybrigenics, a bio-pharmaceutical company listed on the Alternext market of Euronext in Paris, with a focus on research and development of new treatments against proliferative diseases, announced the end of the clinical Phase II study of inecalcitol in chronic lymphocytic leukemia (CLL). Out of the 24 enrolled patients in the CLL study, twenty-one evaluable patients have been treated for at least 4 months and up to 23 months with 2 mg/day of oral inecalcitol alone. Eleven patients (52%) showed a decrease or a stabilization of their blood lymphocyte counts (BLC); one out of these eleven patients achieved a -95% decrease in BLC after 10 months of treatment and another one had around -45% BLC reduction after 4 and 5 months of treatment. The BLC of 10 other patients (48%) have increased at a regular exponential pace without any influence of the treatment. Seven patients dropped out of the study to receive immuno-chemotherapy: six in the group of patients with no obvious effect of the treatment and one at one year in the study after an initial phase of stabilization. Two patients experienced hypercalcemic adverse events (one grade 3 and one grade 4) attributable to inecalcitol after 15 and 17 months of treatment. 

* On February 4, 2014, Hybrigenics, a bio-pharmaceutical company listed on the Alternext market of Euronext in Paris, with a focus on research and development of new treatments against proliferative diseases, has announced the presentation of an update on the Phase II clinical trial of inecalcitol in chronic lymphocytic leukemia (CLL) at a public seminar jointly organized by FlandersBio and Janssen Pharmaceutica in Hasselt, Belgium. Enrolment has been completed with the 24th patient. Out of 17 patients treated by oral inecalcitol at 2 mg/day for already more than 6 months, the blood lymphocytes counts (BLC) of eleven patients stopped growing when treatment was initiated. BLC have remained stable for at least 6 months in 10 patients. One out of the eleven responders achieved a -90% decrease in BLC after 10 months of treatment. Six patients did not show a response on their BLC at any time point. Two other patients dropped out of the study to receive immuno-chemotherapy after 4 or 5 months of treatment. No patient has been withdrawn from the study because of side effects attributable to inecalcitol, such as hypercalcemia. The proportion between the 11 responders (58%) and the 8 non-responders (42%) to inecalcitol treatment is in line with the 60%/40% ratio of the last update.

* On June 3, 2013, Hybrigenics gave an update on the clinical study of inecalcitol in chronic lymphocytic leukemia (CLL). Inecalcitol is given orally at 2 milligrams per day during at least 6 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 or anemia and, thereby, the need for immuno-chemotherapy. A total of twenty-three CLL patients are currently under treatment with inecalcitol. So far, no patient had to stop treatment to undergo immuno-chemotherapy, nor experienced any side effects, such as hypercalcemia. Out of these twenty-three patients, five have completed at least 6 months of treatment. Two patients did not show any change in the increase rate of their blood lymphocytes count (BLC) but did not develop any additional symptom. The BLC of two other patients stopped to increase with treatment initiation and has remained stable ever since. There was a marked decrease in BLC in another patient of about -50% at 6 months and -80% one month later. “The present observations, although still limited to a small number of patients, are encouraging. They also indicate that 6 months appear to be the minimum duration before which any conclusion on individual response to treatment can be drawn.” said Prof. Olivier Hermine.

* On April 8, 2013, Hybrigenics has given an update on the clinical study of inecalcitol in chronic lymphocytic leukemia (CLL). The Phase II clinical study is 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. The study currently involves thirteen centres in France. 

Inecalcitol is given orally at 2 milligrams per day during at least 6 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 or anemia and, thereby, the need for immuno-chemotherapy.  As of today, a total of twenty CLL patients have been enrolled in the study. Nine of them have completed at least 3 months of treatment. So far, no patient had to stop treatment to undergo immuno-chemotherapy, nor experienced any side effects, such as hypercalcemia. 

* On September 11, 2012, Hybrigenics has announced the start of a Phase II clinical trial of oral inecalcitol in patients with chronic lymphocytic leukemia (CLL). Last March the French National Drug Safety Agency has granted authorization for this trial Depending on enrolment speed, this study should last until end of 2013 or beyond. Funding of this clinical trial has been secured by a €3.3 million PIPE in March this year. The first two patients have received their first treatments. 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.

* On March 13, 2012, Hybrigenics has announced that the French National Drug Safety Agency has granted authorization for a Phase II clinical trial of oral inecalcitol in patients with CLL under an Investigational Medicinal Product Dossier (IMPD) procedure. Filed in January this year, Hybrigenics’ IMPD application has been approved within the minimum 2-month regulatory timeframe. Oral inecalcitol is currently being tested at 4 mg per day for treatment of moderate-to-severe psoriasis in a placebo-controlled double-blind clinical trial. The results of this Phase II study are expected in June 2012. Oral inecalcitol has previously shown excellent tolerance and a strong presumption of efficacy in a phase IIa dose-finding clinical study in prostate cancer in combination with Taxotere®. Hybrigenics has also announced the successful closing of a € 1.85 million private placement to institutional investors to finance this new phase II study.

* On January 19, 2012, Hybrigenics has filed an application to conduct a clinical trial of inecalcitol in patients with with chronic lymphocytic leukemia (CLL). The answer of the French National Agency for the Safety of Medicines is expected before the end of March 2012. This is the third potential therapeutic indication for oral inecalcitol. Clinical trials are already underway to assess inecalcitol in the treatment of psoriasis and castrate-resistant prostate cancer.