Israeli clinical-stage biopharmaceutical company BiolineRX Ltd. (Nasdaq: BLRX); TASE:BLRX) has announced positive results from an ongoing Genesis Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma (blood cancer) patients.
Following interim analysis by the Data Monitoring Committee (DMC), and based on the statistically significant evidence favoring treatment with motixafortide, the DMC issued a recommendation to BiolineRX that patient enrollment may be immediately halted, without the need to recruit all 177 patients originally planned for the study.
In the wake of the DMC's recommendation, study enrollment is now complete at 122 patients. Full results for the study, which began in December 2017, including secondary and exploratory efficacy endpoints, as well as extended safety data, will be announced in the first half of 2021 after the last patient enrolled reaches 100 days of follow-up post-transplantation.
BiolineRX CEO Philip Serlin said, "The compelling results of this planned interim analysis are a very significant milestone for our Company, as our SCM program is the Company's most efficient path to registration for motixafortide. Stem cell mobilization represents a significant unmet medical need in multiple myeloma, as between 50% and 70% of patients are poor mobilizers. We eagerly await the final results of the study, expected in the first half of next year, which we hope will support our goal of changing the treatment paradigm in autologous stem-cell mobilization, thus positioning motixafortide in combination with G-CSF as the new standard of care in this indication."
BiolineRX was founded in 2003 as a drug development incubator. The company saw its share price rise 34% on Nasdaq on Friday to $1.98, giving a market cap of $30.62 million. The company share price is up 52% on the TASE today.
Published by Globes, Israel business news - en.globes.co.il - on November 1, 2020
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