Hybrigenics provided update on the phase II clinical study of inecalcitol in chronic myeloid leukemia (CML) administered in addition to imatinib. In CML: a 3 log decrease (1,000-fold) in BCR-ABL is called a major molecular response (MMR) and a 4.5 log decrease (31,623-fold) a deep molecular response (DMR). Between the MMR and DMR levels, the disease is considered to be under control with continuous daily administration. With levels sustained in DMR, the minimal residual CML disease is sufficiently low that treatment cessation can be considered and functional cure achieved in some patients. The ongoing, open-label Phase II study evaluates the efficacy of oral inecalcitol added to oral imatinib in CML patients who, after at least two years of treatment with imatinib alone, have achieved MMR but not DMR, with the objective to reach DMR within one year of treatment. 21 patients have been enrolled to date: 12 remain under treatment and 9 have completed one year of treatment. At this intermediate stage of study, 43% of the patients (6 out of 14) have shown further decrease in BCR-ABL from MMR at three months, and after one year of treatment, 33% (3 out of 9) have demonstrated reduction in BCR-ABL beyond DMR, i.e. undetectable biomarker traces. These results can be compared with two recently published independent reports which demonstrate a simple 7.5% yearly increase in the percentage of patients reaching DMR under imatinib alone. Based on these intermediate results and a very low study drop-out rate, the sample size of this pilot study has been reduced to 42 patients, with a target completion in H2 2018. Company’s Clinical Advisory Board has reviewed these preliminary observations and made suggestions to widen the scope of the potential clinical use of inecalcitol in CML.