BioLineRx Ltd (NASDAQ:BLRX) a clinical-stage cancer specialist, today announced that results from a Phase2a trial suggest that its drug BL-8040 lifts survival rates in patients with relapsed or refractory acute myeloid leukemia.
The study reveals that when BL-8040 is taken in combination with the chemotherapy drug Cytarabine, the life of patients with relapsed acute myeloid leukemia is extended by several months.
The response rate in the study for all dosing levels was 29% and median overall survival was 9.1 months, compared with historical data which shows that patients taking cytarabine on its own tend to live for 6.1 months.
The bigger the dose, the better the outcome, as patients who received 1.5mg of BL-8040 reported a response rate of 39% and a survival rate of 10.7 months.
The new findings also indicate that a correlation exists between patient’s response levels and a surge in the number of acute myeloid leukemia blasts in the blood following treatment with BL-8040. This occurrence identifies a potential biomarker for selecting patients likely to respond to BL-8040.
It also means that BL-8040 is driving acute myeloid leukemia cells out of the bone marrow and into the blood where "they are killed with chemotherapy," points out Maxim Group's research analyst Jason McCarthy.
BL-8040 is a short peptide for the treatment of acute myeloid leukemia as well as solid tumors.
Impressed by the trial results, Mark Breidenbach, a research analyst with Oppenheimer, argues that BL-8040’s use is likely to be expanded to include some forms of stem cell transplants. Further readouts on the data for BL-8040, which was presented at the 23rd Annual Congress of the European Hematology Association in Stockholm, is expected in the second half of the year.
“We believe the European Hematology Association update underscores the versatility and safety of [BL-8040],” wrote Breidenbach, who maintains an Outperform rating and a US$3 price target on BioLineRx’s stock.
“We believe the [conference] updates underscore BL-8040’s synergy with chemotherapy in AML patients and point to a future expansion into the allogeneic [stem cell] transplant market, assuming the drug is approved for use in autologous transplants.”
Maxim Group's McCarthy is just as bullish.
"The BL-8084 platform continues to make progress across multiple indications and data from several studies is expected over the remainder of 2018 which, if positive, should represent catalysts for the stock," he wrote in a note to investors. He is keeping a Buy rating and a US$2 price target on the stock.
BioLineRx shares were down 4.2% to US$0.96 in afternoon trade.
-- Adds comments from a Maxim Group analyst; updates share price --