The pharmaceutical company Dwarf Basket, held (5%) by
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(3%) and traded on NASDAQ (NYSE: GMDA) rose more than 60% yesterday after trading closed, after reporting success in a Phase 3 clinical trial of omidubicel treatment for malignant hematologic diseases requiring bone marrow transplantation. Based on results The dwarf experiment estimates that in the second half of the year it will apply for FDA approval.
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Dwarf reported that the treatment was able to prolong the time between the date of omidubicel transplantation and the uptake of neutrophil blood cells, with the median time to uptake being 12 days in the experimental group, which included 62 patients, compared to 22 days in the control group (63 people in which Standard of umbilical cord blood stem cells).
This is the main goal of dwarfism in the trial, and the company reported that the secondary goals were also achieved:: The proportion of patients in whom platelet absorption was achieved within 42 days of transplantation was 55% in the experimental group versus 35% in the control group, the proportion of patients with moderate bacterial / fungal infections Severe in the 100 days after transplantation was 37% in the experimental group versus 57% in the control group. In addition, the number of days in which patients were not hospitalized in the one-hundred-day period after transplantation averaged 5.60 days in the experimental group, compared with an average of 0.48 days in the control group.
Dwarf further reported that in terms of rates of host-versus-host disease (GvHD) cases there was no significant statistical difference between the groups, and in both the rate was low. The mortality rate unrelated to disease recurrence was 11% in the omidubicel group of patients compared with 24% in the control group.
Dwarf Basket develops products for curing cancer and rare diseases of the bone marrow. Omidubicel treatment is the subject of the current report, based on umbilical cord blood stem cells enriched with technology developed by the company. The treatment is now also being tested in a clinical trial in patients with severe aplastic anemia. Dwarf also is developing a product called 201-GDA that is in a Phase 1 clinical trial in patients with Hodgkin-non lymphoma and multiple myeloma.
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