Enrollment to cease im­medi­ately; top­line data antic­i­pated in H1 2021

Tel Aviv, Israel (Press Release) – Bio­LineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy, to­day an­nounced pos­i­tive re­sults from a planned interim analysis of the on­go­ing GENESIS Phase 3 trial of motix­a­fortide for stem cell mo­bi­li­za­tion (SCM) in mul­ti­ple myeloma patients.

At a meeting of the study's in­de­pen­dent Data Monitoring Com­mit­tee (DMC), a planned interim analysis of the study's pri­mary end­point was con­ducted in­de­pen­dent­ly by the DMC. Based on the statistically sig­nif­i­cant evi­dence favoring treat­ment with motix­a­fortide, the DMC issued a recom­men­da­tion to the Com­pany that patient …

Interim analysis in GENESIS to be com­pleted in next few months

Tel Aviv, Israel (Press Release) – Bio­LineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy, to­day an­nounced that a suf­fi­cient num­ber of patients (~65% of the original planned sample size) have been en­rolled in the on­go­ing GENESIS Phase 3 trial to allow for an interim ef­fi­cacy analysis to take place in the sec­ond half of 2020. This on­go­ing reg­is­tra­tional study is investigating motix­a­fortide (BL-8040) for the mo­bi­li­za­tion of hema­to­poietic stem cells (HSCs) for au­tol­o­gous trans­plan­ta­tion in patients with mul­ti­ple myeloma. If the pri­mary end­point is met at the …

Data from first lead-in patient cohort prompts Data Monitoring Com­mit­tee to rec­om­mend early con­tin­u­a­tion to ran­dom­ized placebo-controlled part 2 of trial

Tel Aviv, Israel (Press Release) – BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy and immunology, an­nounced to­day pos­i­tive re­sults from the lead-in period of the GENESIS trial, a double-blind, placebo-controlled Phase 3 trial com­par­ing BL-8040 in com­bi­na­tion with granulocyte colony-stimulating factor (G-CSF), to G-CSF alone, for the mobili­za­tion of hema­to­poietic stem cells (HSCs) used for au­tol­o­gous trans­plan­ta­tion in mul­ti­ple myeloma patients.

The open-label, single-arm, lead-in period of the study was de­signed to in­clude up to 30 patients, with Data Monitoring Com­mit­tee (DMC) re­view after com­ple­tion of …