Stock Bioline RX is up about 50% to a modest value of more than $ 40 million in trading on the NASDAQ, after reporting positive intermediate results from the third-stage clinical trial GENESIS – which is testing motixafortide for the circulation of circulating stem cells in patients with multiple myeloma.
The trial’s independent data monitoring committee (DMC) performed as planned an independent analysis of the intermediate results of the trial’s primary target, and based on significant statistical results in favor of motixafortide treatment at the trial’s primary target, recommended immediate cessation of patient recruitment, without completion of recruitment. The 177 patients originally planned. In accordance with the recommendation of the Data Monitoring Committee, the recruitment of patients for the trial has now been completed and stands at 122 patients.
Full results from the trial, including secondary and efficacy targets as well as safety data, will be published in the first half of 2021, after the last patient recruited for the trial completes 100 days after the transplant. Philip Serlin, CEO of Bioline RX, said that stem cell mobility is an important area for the treatment of multiple myeloma – given the fact that 50% -70% of patients are unable to carry enough stem cells. He noted that Bioline hopes the final results of the experiment will motixafortide in combination with G-CSF as the usual treatment for this disease.
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The GENESIS trial began in December 2017, and is a randomized, placebo-controlled trial conducted at several centers, to ensure the safety, tolerability, and efficacy of motixafortide and G-CSF compared to placebo and G-CSF, for the purpose of motopoietic stem cell (HSCs) mobilization.
Common myeloma affects the bone marrow, kidney bones, and immune system. The disease is caused by type B white blood cells that have differentiated into plasma cells. The disease is manifested by a proliferation of plasma cells in the bone marrow, which secrete a monoclonal antibody found in the blood and urine. Multiple myeloma is the second most common form of leukemia and 4.5% of 100,000 people are diagnosed with the disease each year. The incidence of the disease increases after the age of 50 and the number of men suffering from it exceeds the number of women.
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