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The FDA granted orphan drug designation to CLBS12, an investigational nongene-edited cell therapy for the treatment of Buerger’s disease, according to the agent’s manufacturer.
Buerger’s disease, also known as thromboangiitis obliterans, is a condition related to critical limb ischemia and has no approved treatments in the United States.
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CLBS12 (Honedra, Caladrius Biosciences) is an autologous cell therapy derived from CD34+ cells. Patients who receive the therapy undergo apheresis that includes drug-induced mobilization of CD34+ cells from bone marrow. The cells are subsequently isolated, concentrated and administered as an IV infusion.
/PRNewswire/ RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced its plans to expand.
RedHill Biopharma Announces Planned Expansion of Opaganib Global Phase 2/3 COVID-19 Study to the U S prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
Credit: RedHill Biopharma
Opaganib targets a human cell component involved in viral replication and is therefore expected to be effective against emerging viral variants with mutations in the spike protein
Preliminary data from the non-powered U.S. Phase 2 study of opaganib demonstrated safety and positive efficacy data across key primary and secondary endpoints
TEL AVIV, Israel and RALEIGH, NC, January 29, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) ( RedHill or the Company ), a specialty biopharmaceutical company, today announced that the independent Data Safety Monitoring Board (DSMB) for the global Phase 2/3 study of opaganib in patients with severe COVID-19, unanimously recommended to continue the study following a pre-scheduled futility review of unblinded efficacy data from the first 135 patients treated in the study and safety data from the first 175 patients.
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TEL AVIV, Israel and RALEIGH, N.C., Jan. 29, 2021 /PRNewswire/ RedHill Biopharma Ltd. (Nasdaq: RDHL) ( RedHill or the Company ), a specialty biopharmaceutical company, today announced that the independent Data Safety Monitoring Board (DSMB) for the global Phase 2/3 study of opaganib
[1] in patients with severe COVID-19, unanimously recommended to continue the study following a pre-scheduled futility review of unblinded efficacy data from the first 135 patients treated in the study and safety data from the first 175 patients. Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity. The positive and unanimous DSMB recommendation is a significant milestone in the progress of our development program for COVID-19 disease. Taken together with the positive results from the Phase 2 study, this unanimous DSMB recommendation to continue the global P