BioLineRX Ltd [NASDAQ:BLRX] was a big gainer last Friday and looks set to extend those gains today. The stock is currently up by over 15% pre-market and gaining. It’s upside momentum comes after the company announced that it had got positive results from its phase 3 interim trial of BL-8040 in stem cell mobilization for people suffering from multiple myeloma.
During the company’s meeting of the Independent Data Monitoring Committee (DMC) on the interim results analysis of the primary endpoint showed that there was statistical evidence to the effect that those treated with Motixafortide, was positive and that the enrollment of new patients could stop without looping in 177 additional patients as it has been planned earlier.
Essentially, the enrollment for the treatment’s study is now deemed complete with 122 patients now taking part it this study. The company also revealed that results from the complete study that takes into consideration the secondary and exploratory endpoints will be released once the last patient hits 100 days of follow-up and will happen in H1 of 2021.
Commenting on this development, the CEO Philip Serlin stated that the results of the analysis were a key milestone in the company’s SCM program. He added that it was the company’s best path towards the Motixafortide registration.
He further stated that the mobilization of stem cells were a representation of some major unmet medical needs for people suffering from multiple myeloma in 50% to 70% who are poor mobilizers. He further stated that the company hoped to support the goal of shifting treatment in autologous stem-cell mobilization, making Motixafortide when used together with G-CSF.
The study has been on going on for some time and the current results are a reflection of more than 3 years of studies. Dubbed the genesis study, it started in 2017 and is a randomized multiple center study testing the safety, efficacy as well as the tolerability of Motixafortide and G-CSF when analyzed in comparison to a study on a placebo.
The main objective of the study has been to show that a single dose of Motixafortide when used with G-CSF is a better treatment compared to G-CSF alone. The study’s secondary endpoint has been to check the time taken to engraftment of platelets and neutrophils, as well as the durability of the engraftment among other endpoints.
BioLineRX Ltd is a biopharma company that develops oncological treatments. It is based in Modi’in, Israel.