Benzinga | Aug 19, 2020 07:01AM EDT

BioLineRx Achieves Enrollment Target In Phase 3 GENESIS Trial For Planned Interim Analysis

TEL AVIV, Israel, Aug. 19, 2020 /PRNewswire/ --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 time of the interim analysis, the Company plans to immediately announce the cessation of further recruitment, without the need to enroll the full planned sample size. In this case, top-line results are expected in the first half of 2021, in order to maintain study blinding for all study endpoints, including those related to engraftment, for a period of 100 days subsequent to transplantation. If the primary endpoint is not reached in the interim analysis, the Company expects recruitment will continue until the originally planned sample size is met.