A Randomized Controlled Double-Blind Phase 3 Study to Assess Characteristics of S 303 Treated RBC Components and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia

The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC transfusion support for acute anemia.

开始日期2013-04-01

申办/合作机构

Cerus Corp.

EUCTR2011-006253-29-DE / Unknown statusN/A

A Randomized Controlled Double-Blind Phase 3 Study to Assess Characteristics of S-303 Treated RBC Components and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia - Not applicable

开始日期2012-07-31

申办/合作机构

Cerus Corp.

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100 项与 Amustaline 相关的专利（医药）

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项与 Amustaline 相关的文献（医药）

2024-06-01·Transfusion

In vivo genotoxicity assessment of N‐(‐9 acridinyl)‐b‐alanine hydrochloride (S‐300) using a validated Pig‐a mutagenesis assay

Article

作者: Stankowski, Leon F. ; Ricaud, Guillaume ; Mufti, Nina ; Ling, Katherine ; North, Anne ; Corash, Laurence ; Benjamin, Richard J. ; Bentow, Stanley ; Daly, Jennifer A.

AbstractBackgroundN‐(‐9 acridinyl)‐b‐alanine hydrochloride (S‐300) is the main byproduct of red blood cell (RBC) amustaline/glutathione(GSH) pathogen reduction, currently undergoing phase III US clinical trials following successful European studies(1–3). Phosphatidylinositol glycan, class A (Pig‐a) X‐linked gene mutagenesis is a validated mammalian in vivo mutation assay for genotoxicity, assessed as clonal loss of glycosylphosphatidylinositol‐linked CD59 cell‐surface molecules on reticulocytes (RETs) and RBCs.MethodsMale Sprague–Dawley rats received continuous infusion of S‐300 up to the maximum feasible dose (240 mg/kg/day—limited by solubility and volume) for 28 days. Positive controls received a known mutagen by oral gavage on Days 1–3. Plasma levels of S‐300 were assessed by HPLC before, during and after infusion. CD59‐negative RBCs and RETs were enumerated in pre‐dose and Day 28 samples, using a flow cytometric method. Outcome was evaluated by predetermined criteria using concurrent and historical controls. Toxicity was assessed by laboratory measures and necropsy.ResultsS‐300 reached maximum, dose‐dependent levels (3–15 μmol/L) within 2–8 h that were sustained for 672 h and undetectable 2 h after infusion. Circulating RET levels indicated a lack of hematopoietic toxicity. Necropsy revealed minimal‐mild observations related to poor S‐300 solubility at high concentrations. Pig‐a assessment met the preset acceptability criteria and revealed no increase in mutant RBCs or RETs.ConclusionsMaximum feasible S‐300 exposure of rats by continuous infusion for 28 days was not genotoxic as assessed by an Organization for Economic Cooperation and Development‐compliant, mammalian, in vivo Pig‐a gene mutation assay that meets the requirements of International Conference on Harmonization (ICH) S2(R1) and FDA guidances on genotoxicity testing.

2022-07-01·Transfusion

Mitigating the risk of transfusion‐transmitted infections with vector‐borne agents solely by means of pathogen reduction

Article

作者: Groves, Jamel A. ; Brodsky, Jaye P. ; Tonnetti, Laura ; Krysztof, David E. ; Lanteri, Marion C. ; Notari, Edward ; Stramer, Susan L. ; Stone, Mars ; Foster, Gregory A. ; Simmons, Graham ; Spencer, Bryan ; Busch, Michael P. ; Townsend, Rebecca L. ; Bakkour, Sonia

AbstractBackgroundThis study evaluated whether pathogen reduction technology (PRT) in plasma and platelets using amotosalen/ultraviolet A light (A/UVA) or in red blood cells using amustaline/glutathione (S‐303/GSH) may be used as the sole mitigation strategy preventing transfusion‐transmitted West Nile (WNV), dengue (DENV), Zika (ZIKV), and chikungunya (CHIKV) viral, and Babesia microti, Trypanosoma cruzi, and Plasmodium parasitic infections.MethodsAntibody (Ab) status and pathogen loads (copies/mL) were obtained for donations from US blood donors testing nucleic acid (NAT)‐positive for WNV, DENV, ZIKV, CHIKV, and B. microti. Infectivity titers derived from pathogen loads were compared to published PRT log10 reduction factors (LRF); LRFs were also reviewed for Plasmodium and T. cruzi. The potential positive impact on donor retention following removal of deferrals from required questioning and testing for WNV, Babesia, Plasmodium, and T. cruzi was estimated for American Red Cross (ARC) donors.ResultsA/UVA and S‐303/GSH reduced infectivity to levels in accordance with those recognized by FDA as suitable to replace testing for all agents evaluated. If PRT replaced deferrals resulting from health history questions and/or NAT for WNV, Babesia, Plasmodium, and T. cruzi, 27,758 ARC donors could be retained allowing approximately 50,000 additional donations/year based on 1.79 donations/donor for calendar year 2019 (extrapolated to an estimated 125,000 additional donations nationally).ConclusionPathogen loads in donations from US blood donors demonstrated that robust PRT may provide an opportunity to replace deferrals associated with donor questioning and NAT for vector‐borne agents allowing for significant donor retention and likely increased blood availability.

2022-05-01·Transfusion3区 · 医学

Robust inactivation of Plasmodium falciparum in red blood cell concentrates using amustaline and glutathione pathogen reduction

3区 · 医学

Article

作者: Girard, Yvette A. ; Bouissou, Amélie ; Bounaadja, Lotfi ; Isola, Hervé ; Grellier, Philippe ; Bringmann, Peter ; Lanteri, Marion C. ; Singh, Gurvani B. ; Payrat, Jean‐Marc ; Sow, Cissé ; Haas, Delphine

AbstractBackgroundPlasmodium falciparum is the parasite responsible for most malaria cases globally. The risk of transfusion‐transmitted malaria (TTM) is mitigated by donor deferrals and blood screening strategies, which adversely impact blood availability. Previous studies showed robust inactivation of P. falciparum using nucleic acid‐targeting pathogen reduction technologies (PRT) for the treatment of plasma and platelet components or whole blood (WB). The efficacy of the amustaline–glutathione (GSH) PRT to inactivate P. falciparum is here evaluated in red blood cells (RBC), as well the impact of PRT on parasite loads, stages, and strains.Study Design and MethodsRBC units resuspended in AS‐1 or AS‐5 additive solutions were spiked with ring stage‐infected RBC and treated with the amustaline–GSH PRT. Parasite loads and viability were measured in samples at the time of contamination, and after treatment, using serial 10‐fold dilutions of the samples in RBC cultures maintained for up to 4 weeks.ResultsP. falciparum viability assays allow for the detection of very low levels of parasite. Initial parasite titer was >5.2 log10/ml in AS‐1/5 RBC. No infectious parasites were detected in amustaline–GSH‐treated samples after 4 weeks of culture. Amustaline–GSH inactivated high parasite loads regardless of parasite stages and strains. Amustaline readily penetrates the parasite, irreversibly blocks development, and leads to parasite death and expulsion from RBC.DiscussionAmustaline–GSH PRT demonstrated robust efficacy to inactivate malaria parasites in RBC concentrates. This study completes the portfolio of studies demonstrating the efficacy of nucleic acid‐targeting PRTs to mitigate TTM risks as previously reported for platelet concentrates, plasma, and WB.

项与 Amustaline 相关的新闻（医药）

2024-10-18

·BioSpace

Cerus Corporation Announces Workshop and Abstracts at the 2024 AABB Annual Meeting

Presentations Highlight the Unique Benefits of Real-world Utilization of INTERCEPT-treated Blood Products, Including INTERCEPT Fibrinogen Complex, and Recent Findings from the Phase 3 ReCePI Clinical Trial CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) today announced a selection of abstracts to be presented at the 2024 Association for the Advancement of Blood & Biotherapies (AABB) Annual Meeting, taking place in Houston, Texas from October 19 through October 22. This year’s AABB Annual Meeting attracts individuals and institutions from around the globe involved in the fields of transfusion medicine and biotherapies. The following is a select list of Cerus-related presentations and abstracts. All presentation times are listed in Central Daylight Time (CDT). Oral Presentations Sunday, October 20, 2024 – 9:30 a.m.– Acute Kidney Injury to Evaluate Amustaline/Glutathione Pathogen Reduced Red Cells in Cardiac Surgery: Outcomes of the ReCePI Phase III Clinical Trial (Speaker: E. Snyder) Monday, October 21 – 9:45 a.m. – Utilizing Sankey Diagrams to Quantify Laboratory Efficiency of INTERCEPT Fibrinogen Complex vs Traditional Cryoprecipitate (Speaker: D. Chen) Monday, October 21, 2024 – 2:00 p.m. – Phase IV Trial of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOPCLOT) in Cardiac Surgery (Speaker: M. Cushing) Monday, October 21, 2024 – 2:00 p.m. – HLA Alloimmunization in ReCePI, a Phase III Study of Amustaline/Glutathione Pathogen Reduced RBCs (Speaker: P. Norris) Monday, October 21, 2024 – 2:00 p.m. – Treatment-Emergent Antibodies to Amustaline/Glutathione Pathogen-Reduced Red Blood Cells in the ReCePI Phase III Clinical Trial (Speaker: R. Benjamin) Poster Presentations Held Sunday, October 20 and Monday, October 21, 2024 Evaluation of Pathogen Reduction Efficacy in Platelet Concentrates Until End of Shelf-Life with Two Different Automated Bacterial Detection Systems Development of a Next Generation Illuminator for Photochemical Inactivation of a Broad Spectrum of Pathogens in Platelet Concentrates Accelerating Treatment Delivery and Reducing Waste with Implementation of Pathogen Reduced Cryoprecipitated Fibrinogen Complex Wastage and Cost Analysis for INTERCEPT Fibrinogen Complex An Analysis of Anesthesiologist and Transfusion Service Staff Preferences Between Pathogen Reduced Cryoprecipitated Fibrinogen Complex and Conventional Cryoprecipitated AHF Analysis of Wastage, Savings, and Maternal and Pediatric Outcomes for Pooled Pathogen Reduced Cryoprecipitate versus Conventional Cryoprecipitate Pathogen Reduced Cryoprecipitate Implementation and Assessment of Its Impact in a Large Academic Medical Center Implementation of INTERCEPT Fibrinogen Complex (IFC) for Postpartum Hemorrhage Evaluation of INTERCEPT RBC Pathogen Reduction in Combination with Irradiation Industry Workshop Monday, October 21, 2024 – 7:00 a.m.– Industry Workshop Presented by Cerus: Pathogen Reduced Blood Components – Current Experiences and Future Developments with the INTERCEPT® Blood System (Speakers: J. Squires, C. Ingold, E. Snyder) The full program of Cerus-related abstracts can be found at the following link: Cerus representatives will be in the exhibition area at booth #431. ABOUT CERUS Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both C.E mark and FDA approval for these two blood components. In the U.S, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is in late-stage clinical development. For more information about Cerus, visit and follow us on LinkedIn. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation. Contacts Jessica Hanover Cerus Corporation 925-288-6137

临床3期

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适应症	最高研发状态	国家/地区	公司	日期
急性出血后贫血	临床3期	德国	Cerus Corp.	2013-04-01
病毒感染	临床3期	-	Baxter International, Inc.	-
病毒感染	药物发现	-	Cerus Corp.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01716923 (Pubmed \| Transfusion)	临床3期	-	774	Amustaline-treated RBCs	齋網醖築網衊鑰憲鑰餘(繭餘襯壓顧齋窪艱網糧) = 獵衊簾簾蓋願顧顧簾蓋齋憲糧願鬱醖窪積憲範 (範簾遞艱醖憲鹹簾鑰膚, -2.61 ~ -1.92)	-	2018-04-01