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Leukine is FDA Authorised to Deal with Acute Radiation Syndrome (ARS) and Beneficial in EMEA/CPMP Steering to Deal with Systemic Sulfur Mustard (HD) Fuel Publicity
“In response to the continuing battle in Ukraine, Tanner is supporting preparedness and response in Europe by growing the native stock of Leukine that may be quickly deployed in response to an emergency,” stated Banks Bourne, CEO and Founding father of Tanner Pharma. “The distinctive efficacy of Leukine, which has been proven to enhance survival when given inside 96 hours after radiation publicity and with out complete blood transfusions, makes it a extremely efficient countermeasure with necessary logistical benefits within the occasion of a nuclear detonation. Positioning extra provide in Europe ensures that extra Leukine is obtainable shortly, if wanted.”
Leukine is an immune system modulator that’s FDA authorized to deal with the hematopoietic results of acute radiation syndrome and has been held to be used by the U.S. Authorities as a medical countermeasure since 2013. Leukine can be really helpful to deal with H-ARS within the Worldwide Atomic Power Affiliation (IAEA) 2020 Medical Administration of Radiation Accidents(1) and was used to efficiently deal with some victims of the Chernobyl Nuclear Energy Plant in 1986.(2) Past ARS, Leukine is really helpful in EMEA/CPMP Steering Doc on the Use of Medicinal Merchandise for the Therapy of Sufferers Uncovered to Terrorist Assaults with Chemical Brokers as a remedy for publicity to sulfur mustard (HD) fuel.(3) It’s presently beneath growth, however not presently FDA-approved to be used towards sulfur mustard publicity.
Excessive doses of radiation profoundly injury the physique’s immune system. Broken cells embrace monocytes, macrophages, platelets, neutrophils, dendritic cells and crimson blood cells, in different phrases, pancytopenia. Leukine stimulates every of those cell varieties and is proven to speed up restoration from pancytopenia. Its broad affect permits elevated survival from ARS with out the necessity for blood transfusions. It is a vital benefit given the expectation that after a radiological or nuclear occasion, blood merchandise might be restricted or unavailable. It is usually the one ARS countermeasure that has been proven to be efficient when administered greater than 24 hours after publicity. The truth is, the research have proven efficacy when administered as much as 96 hours after publicity. (4,5) Within the aftermath of radiological or nuclear occasion, a 48-96 hour remedy window is totally vital. (6,7) The logistical challenges of creating provides and well being care professionals accessible for response and remedy counsel will probably be 2 days earlier than medication might be administered at any scale. Leukine can be steady at room temperature for 12 months, eliminating the necessity for a refrigerated provide chain in a disaster.
Beneath is a abstract of the usage of Leukine for Acute Radiation Syndrome (ARS) and Sulfur Mustard (HD) Fuel Publicity supplied by Associate Therapeutics:
ABOUT LEUKINE IN ACUTE RADIATION SYNDROME (ARS)
Leukine is FDA authorized to extend survival in sufferers uncovered to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome or H-ARS). Information from a number of GLP NHP research funded by the U.S. Biomedical Superior Analysis and Improvement Authority (BARDA) exhibit that Leukine will increase survival by stimulating thrombopoiesis and considerably growing platelet rely along with accelerating the restoration of leukocytes and reticulocytes, thereby addressing all three main elements of hematopoietic injury from radiation publicity, collectively pancytopenia. NHP research present that Leukine improves survival and accelerates restoration from myelosuppression (together with thrombocytopenia) when given as much as 96 hours publish radiation publicity. (4,5,8) Leukine just isn’t EMA authorized for H-ARS.
Leukine is a yeast-derived recombinant type of Granulocyte-Macrophage Colony Stimulating Issue (GM-CSF), a pleiotropic small protein that promotes the technology of megakaryocytic and erythroid progenitors and induces progenitor cells to divide and differentiate throughout the granulocyte and macrophage pathways. Leukine induces manufacturing, maturation and differentiation of the myeloid lineages of hematopoietic precursor cells, together with granulocyte, macrophage, platelet, dendritic cell and crimson cell lineages. It additionally prompts mature granulocytes and monocytes, growing their phagocytic and lytic properties. Leukine’s affect on platelets, monocytes, macrophages, and dendritic cells, along with its identified results on neutrophils, has been proven throughout a number of illness states and helps its use in H-ARS.
ABOUT LEUKINE IN SULFUR MUSTARD (HD) GAS EXPOSURE
Leukine just isn’t FDA or EMA authorized to deal with HD fuel publicity. Leukine is really helpful in EMEA/CPMP Steering Doc on the Use of Medicinal Merchandise for the Therapy of Sufferers Uncovered to Terrorist Assaults with Chemical Brokers as a remedy for publicity to HD fuel.
HD publicity suppresses bone marrow perform, resulting in myelosuppression and pancytopenia. Leukopenia was reported in sufferers requiring hospitalization after publicity throughout WWI, WWII and the Iran-Iraq Battle, and mortality was reported in all instances the place leukocyte counts dropped beneath 200/µl6. Whereas mortality is reported in lower than 2.5% of all uncovered to HD, hematological injury is the first driver of hospitalization and extreme hematological injury is the first explanation for mortality. (10)
Leukine accelerates restoration of bone marrow perform and restoration from pancytopenia and reduces deaths from infections in individuals with bone marrow failure beneath numerous circumstances together with following intensive chemotherapy and after acute high-dose complete physique radiation within the context of hematopoietic cell transplants.(4,5,8) Each medical expertise in individuals receiving Leukine after chemotherapy and therapeutic radiation and information from GLP NHP ARS research supporting Leukine’s approval and use in these indications, exhibit that Leukine accelerates restoration from bone marrow suppression and pancytopenia and reduces the speed of an infection and septicemia, and is probably going to offer the identical profit after HD publicity. (4-5,September 11)
ABOUT TANNER PHARMA GROUP
(1) Medical administration of radiation accidents, Vienna, Worldwide Atomic Power Company, 2020; Security Studies Collection no. 101.
(2) Dainiak N, Medical administration of acute radiation syndrome and related infections in a high-casualty incident, Journal of Radiation Analysis, Vol. 59, No. S2, 2018, p. ii54-ii64. Doi:10.1093/jrr/rry004
(3) EMEA/CPMP Steering Doc on the Use of Medicinal Merchandise for the Therapy of Sufferers Uncovered to Terrorist Assaults with Chemical Brokers; The European Company for the Analysis of Medicinal Merchandise Pre-authorisation Analysis of Medicines for Human Use, London, 25 April 2003; EMEA/CPMP/1255/03
(6) Yeddanapudi N, et. al., (2018): Informing CONOPS and medical countermeasure deployment methods after an improvised nuclear system detonation: the significance of delayed remedy efficacy; Int. J. Radiat. Biol.
(9) Leukine Bundle Insert
(10) Willems, JL, Medical administration of mustard fuel casualties, Ann Med Milit Belg 1989; 3: S1-61.
(11) Sezigan S, et. al., Myelosuppression and acute hematological problems of sulfur mustard publicity in victims of chemical terrorism, Toxicology Letters 318 (2020) 92-98.
Contacts
Christine Quern
CBQ Communications
617.650.8497
Supply: Tanner Pharma Group
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