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Journal articles on the topic 'Cer-001'

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Published: 7 July 2024

Last updated: 7 July 2024

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1

Zheng, Kang He, Fleur M. van der Valk, Loek P. Smits, Mara Sandberg, Jean-Louis Dasseux, Rudi Baron, Ronald Barbaras, et al. "HDL mimetic CER-001 targets atherosclerotic plaques in patients." Atherosclerosis 251 (August 2016): 381–88. http://dx.doi.org/10.1016/j.atherosclerosis.2016.05.038.

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2

Ossoli, A., A. Strazzella, S. Simonelli, D. Rottoli, M. Abbate, C. M. Zoja, J. L. Dasseux, and L. Calabresi. "Remodeling And Catabolism Of Cer-001 In Absence Of Lcat Enzyme." Atherosclerosis 287 (August 2019): e107. http://dx.doi.org/10.1016/j.atherosclerosis.2019.06.312.

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3

Keyserling, Constance H., Ronald Barbaras, Renee Benghozi, and Jean-Louis Dasseux. "Development of CER-001: Preclinical Dose Selection Through to Phase I Clinical Findings." Clinical Drug Investigation 37, no. 5 (February 17, 2017): 483–91. http://dx.doi.org/10.1007/s40261-017-0506-3.

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4

Nicholls, Stephen J., Jordan Andrews, John J. P. Kastelein, Bela Merkely, Steven E. Nissen, Kausik K. Ray, Gregory G. Schwartz, et al. "Effect of Serial Infusions of CER-001, a Pre-β High-Density Lipoprotein Mimetic, on Coronary Atherosclerosis in Patients Following Acute Coronary Syndromes in the CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial." JAMA Cardiology 3, no. 9 (September 1, 2018): 815. http://dx.doi.org/10.1001/jamacardio.2018.2121.

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5

Li, Chen, Pan Pan Wu, and Kun Zhang. "Preparaitve Separation and Purification of Cordycepin from Cultured Cordyceps militaris Using Cation Exchange Resin." Advanced Materials Research 550-553 (July 2012): 1773–78. http://dx.doi.org/10.4028/www.scientific.net/amr.550-553.1773.

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A main active component cordycepin was extracted and purified from cultured Cordyceps militaris. The crude extract was microwave extracted and then purified using a cation exchange resin (CER) of LSD-001. The adsorption ability of the resin was investigated using equilibrium adsorption isotherm including Langmuir and Freundlich model, and the equilibrated relationship between cordycepin and LSD-001 could be well described by Langmuir equation. The influential factors of desorption experiments, such as NH3 concentration, pH value and ethanol content of desorption solution, along with desorption time and temperature were successively investigated. The optimal desorption conditions were confirmed as: 0.2 mol L-1 NH3 combined with 80% ethanol (v/v), desorbed for 2 h at 25 °C and pH 14. Compared with the content in crude C. militaris (2.5 mg g-1), cordycepin in the final purified products (144.6 mg•g-1) was increased 58-fold after one cycle of dynamic adsorption and desorption on resin LSD-001.

6

Flores-Peña, Yolanda, María Eugenia Pérez-Campa, Hermelinda Ávila-Alpirez, Juana Mercedes Gutiérrez-Valverde, and Gustavo Gutiérrez-Sánchez. "Depressive symptoms, maternal feeding styles, and preschool child’s body weight." Salud mental 44, no. 6 (December 2, 2021): 261–66. http://dx.doi.org/10.17711/sm.0185-3325.2021.034.

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Introduction. Depressive symptoms (DS) can impact maternal child feeding styles (MCFS), and child’s body weight. Objective. 1. Verify if DS are different depending if the child has, or not, overweight-obesity (OW-OB); 2. Identify the MCFS based on the fact that the child has, or not, OW-OB; 3. Verify it DS are different according to MCFS; 4. Identify DS’s predictors. Method. Correlational cross-sectional study. The participants were 259 dyads (mother- preschool child) residents in Mexico’ Northeast. Mothers answered the Center for Epidemiologic Studies Depression Scale, Revised, and the Caregiver Feeding Styles Questionnaire. Mann-Whitney U test, Chi-square test, Kruskall-Wallis H, and multiple linear regression analysis were performed. Results. Twelve point eight percent of the mothers (n = 33) had DS, 35.5% (n = 92) authoritarian MCFS. No significant difference was identified between DS and MCFS according to the child’s OW-OB or lack thereof (U = 5726.0, p #cer# .05 and X2 = .078, gl = 3, p #cer# .05). A significant positive correlation was found between DS and MCFS demandingness (rs = .208, p = .001). The authoritarian MCFS had the highest DS mean (H = 10.70, gl = 3, p #abr# .05). The demandingness predicts the DS (X2 = 826.445, gl = 1, p = .001). Discussion and conclusion. Authoritarian MCFS predominated, DS were higher in mothers with authoritarian MCFS; demandingness predicts DS. It is recommended to promote authoritarian MCFS which favors the development of healthy eating habits.

7

Faguer, Stanislas, Magali Colombat, Dominique Chauveau, Pauline Bernadet-Monrozies, Audrey Beq, Audrey Delas, Vincent Soler, et al. "Administration of the High-Density Lipoprotein Mimetic CER-001 for Inherited Lecithin–Cholesterol Acyltransferase Deficiency." Annals of Internal Medicine 174, no. 7 (July 2021): 1022–25. http://dx.doi.org/10.7326/l20-1300.

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8

Nicholls, Stephen J., Jordan Andrews, John Jp Kastelein, Bela Merkely, Steven E. Nissen, Kausik Ray, Gregory G. Schwartz, et al. "CARAT: will infusing a pre-beta high-density lipoprotein mimetic (CER-001) regress coronary atherosclerosis?" Atherosclerosis 263 (August 2017): e10. http://dx.doi.org/10.1016/j.atherosclerosis.2017.06.060.

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9

Ossoli, A., A. Strazzella, D. Rottoli, C. Zanchi, M. Locatelli, C. Zoja, S. Simonelli, et al. "CER-001 ameliorates lipid profile and kidney disease in a mouse model of familial LCAT deficiency." Atherosclerosis 331 (August 2021): e39. http://dx.doi.org/10.1016/j.atherosclerosis.2021.06.112.

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10

Faguer, S., M. Colombat, D. Chauveau, P. Bernadet, A. Delas, V. Soler, I. Labadens, A. Huart, and J. Schanstra. "Place du mimétique HDL CER-001 dans la glomérulopathie secondaire aux déficits en lécithine-cholestérol acyltransférase (LCAT)." Néphrologie & Thérapeutique 17, no. 5 (September 2021): 317–18. http://dx.doi.org/10.1016/j.nephro.2021.07.182.

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11

Pavanello, Chiara, Marta Turri, Arianna Strazzella, Patrizia Tulissi, Stefano Pizzolitto, Giovanna De Maglio, Riccardo Nappi, Laura Calabresi, and Giuliano Boscutti. "The HDL mimetic CER‐001 remodels plasma lipoproteins and reduces kidney lipid deposits in inherited lecithin:cholesterol acyltransferase deficiency." Journal of Internal Medicine 291, no. 3 (November 11, 2021): 364–70. http://dx.doi.org/10.1111/joim.13404.

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12

Zheng, Kang H., Yannick Kaiser, Casper C. van Olden, Raul D. Santos, Jean-Louis Dasseux, Jacques Genest, Daniel Gaudet, et al. "No benefit of HDL mimetic CER-001 on carotid atherosclerosis in patients with genetically determined very low HDL levels." Atherosclerosis 311 (October 2020): 13–19. http://dx.doi.org/10.1016/j.atherosclerosis.2020.08.004.

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13

Tardy, Claudine, Marine Goffinet, Nadia Boubekeur, Guy Cholez, Rose Ackermann, Gavin Sy, Constance Keyserling, et al. "HDL and CER-001 Inverse-Dose Dependent Inhibition of Atherosclerotic Plaque Formation in apoE-/- Mice: Evidence of ABCA1 Down-Regulation." PLOS ONE 10, no. 9 (September 3, 2015): e0137584. http://dx.doi.org/10.1371/journal.pone.0137584.

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14

Lawrence, Caroline, Erica E. Fortune, Heather Badt, Kara Doughtie, Madyson L. Popalis, and Melissa F. Miller. "Abstract P4-05-01: Cancer-Related Distress and Unmet Needs Among Triple Negative Breast Cancer Patients: Findings from the Cancer Experience Registry." Cancer Research 83, no. 5_Supplement (March 1, 2023): P4–05–01—P4–05–01. http://dx.doi.org/10.1158/1538-7445.sabcs22-p4-05-01.

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Abstract Background: Cancer patients and survivors experience distress related to physical, psychological, social and financial concerns. Individuals diagnosed with triple negative breast cancer (TNBC) may be at increased risk of distress due to the aggressive nature of the illness and high rates of recurrence. The aim of the present study was to describe how TNBC patients characterize cancer-related distress and concerns and identify factors associated with distress. Methods: Cancer Support Community’s Cancer Experience Registry® (CER) is an online research initiative examining the physical, emotional, practical, and financial impact of cancer. The CER measures cancer-related distress using CancerSupportSource™ (CSS), a 25-item validated distress screening tool in which participants rate their level of concern (0=Not at all; 4=Very seriously) across five key domains: (1) emotional well-being (EWB; 8 items, α=.91); (2) symptom burden and impact (SYM; 8 items, α=.90); (3) body image and healthy lifestyle (BHL; 4 items, α=.80); (4) healthcare team communication (HCC; 2 items, α=.74); (5) relationships and intimacy (REL; 2 items, α=.71). CSS subscale scores were calculated as the average item rating. For item analysis, the proportion indicating moderate to very serious concern was reported. From January 2015 to August 2021, a total of 195 US residents with a history of TNBC took part in the CER and completed CSS. Multiple linear regression analysis was used to estimate the relationships between CSS subscales and socio-demographic variables (age, low-income status, employment status) and clinical history (time since diagnosis, advanced or metastatic disease, and currently receiving treatment). Results: The sample was 82% Non-Hispanic White, 7% Non-Hispanic Black, 5% Hispanic, and 7% Non-Hispanic other/multiracial. 17% reported annual household income <$40K. 44% was employed full-time, 12% part-time, 18% retired, and 24% unemployed due to disability or other reason. Mean age was 53 (SD=10) years; 11% were < 40 years. 14% of participants were < 1 year of cancer diagnosis, 27% 1 to < 2 years, 34% 2 to < 5 years, and 25% ≥5 years. 41% were currently receiving treatment, and 27% were diagnosed with advanced or metastatic disease. The mean distress subscale score was highest for concerns about BHL (1.61), followed by EWB (1.29), SYM (1.27), REL (1.04), and HCC (0.83). With regard to concerns about BHL, over half were moderately to very seriously concerned with eating and nutrition (55%) and exercise (55%). Regarding EWB, the items of greatest distress were worrying about the future (53%) and worrying about family (39%). For SYM, over half (53%) were concerned about thinking clearly, and 49% were concerned about fatigue. Participants reported moderate to very serious concern about intimacy, sexual function, and/or fertility (36%) and relationships (22%). Regarding HCC, 24% reported concern related to treatment decisions, while 22% reported concern about communicating with their doctor. In multivariate analysis, time since diagnosis was inversely associated with concerns about EWB (B=-0.03, p=.030), such that distress was higher closer to diagnosis. TNBC patients with advanced or metastatic disease status had significantly higher distress related to SYM (B=0.40, p=.009) and HCC (B=0.61, p=.001). Younger age was associated with concerns about BHL (B=-0.02, p=.011) and REL (B=-0.02, p=.006). Finally, unemployment was associated with higher distress related to EWB (B=0.57, p=.001), SYM (B=0.63, p<.001), BHL (B=0.42, p=0.03), and REL (B=0.70, p<.001). Conclusions: In this sample, average levels indicated slight distress across multiple domains. Many TNBC patients reported concerns that were physical and future-oriented, highlighting critical areas of unmet need. Factors of less time since cancer diagnosis, advanced/metastatic disease, younger age, and unemployment were predictors of higher levels of distress. Citation Format: Caroline Lawrence, Erica E. Fortune, Heather Badt, Kara Doughtie, Madyson L. Popalis, Melissa F. Miller. Cancer-Related Distress and Unmet Needs Among Triple Negative Breast Cancer Patients: Findings from the Cancer Experience Registry [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-05-01.

15

Andrews, Jordan, Alex Janssan, Tracy Nguyen, Anthony D. Pisaniello, Daniel J. Scherer, John J. P. Kastelein, Bela Merkely, et al. "Effect of serial infusions of reconstituted high-density lipoprotein (CER-001) on coronary atherosclerosis: rationale and design of the CARAT study." Cardiovascular Diagnosis and Therapy 7, no. 1 (February 2017): 45–51. http://dx.doi.org/10.21037/cdt.2017.01.01.

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16

Kataoka, Yu, Jordan Andrews, MyNgan Duong, Tracy Nguyen, Nisha Schwarz, Jessica Fendler, Rishi Puri, et al. "Regression of coronary atherosclerosis with infusions of the high-density lipoprotein mimetic CER-001 in patients with more extensive plaque burden." Cardiovascular Diagnosis and Therapy 7, no. 3 (June 2017): 252–63. http://dx.doi.org/10.21037/cdt.2017.02.01.

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17

Hovingh, G. K., E. S. Stroes, D. Gaudet, C. Stefanutti, H. Soran, S. Kwok, J. de Graaf, et al. "Effects of CER-001 on carotid atherosclerosis by 3tmri in homozygous familial hypercholesterolemia (HoFH): The modifying orphan disease evaluation (mode) study." Atherosclerosis 235, no. 2 (August 2014): e13-e14. http://dx.doi.org/10.1016/j.atherosclerosis.2014.05.008.

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18

Tardif, J. C., C. M. Ballantyne, P. Barter, J. L. Dasseux, Z. A. Fayad, M. C. Guertin, J. J. P. Kastelein, et al. "Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial." European Heart Journal 35, no. 46 (April 29, 2014): 3277–86. http://dx.doi.org/10.1093/eurheartj/ehu171.

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19

Tardy, Claudine, Marine Goffinet, Nadia Boubekeur, Rose Ackermann, Gavin Sy, Alice Bluteau, Guy Cholez, et al. "CER-001, a HDL-mimetic, stimulates the reverse lipid transport and atherosclerosis regression in high cholesterol diet-fed LDL-receptor deficient mice." Atherosclerosis 232, no. 1 (January 2014): 110–18. http://dx.doi.org/10.1016/j.atherosclerosis.2013.10.018.

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20

Franzin, Rossana, Alessandra Stasi, Marco Fiorentino, Irene Scalera, Monica Campioni, Maria Teresa Cimmarusti, Giuseppe Castellano, et al. "CER-001, a Recombinant HDL, Modulates Ischemia/Reperfusion Injury (IRI) in Hypothermic (HMP) and Normothermic Perfusion (NMP) Solutions Through pAKT/eNOS Activation." Journal of the American Society of Nephrology 34, no. 11S (November 2023): 23. http://dx.doi.org/10.1681/asn.20233411s123c.

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21

Kootte, Ruud S., Loek P. Smits, Fleur M. van der Valk, Jean-Louis Dasseux, Constance H. Keyserling, Ronald Barbaras, John F. Paolini, et al. "Effect of open-label infusion of an apoA-I-containing particle (CER-001) on RCT and artery wall thickness in patients with FHA." Journal of Lipid Research 56, no. 3 (January 5, 2015): 703–12. http://dx.doi.org/10.1194/jlr.m055665.

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22

Kootte, R. S., L. P. Smits, F. M. van der Valk, J. L. Dasseux, C. Keyserling, R. Barbaras, J. Paolini, et al. "Recombinant human apolipoprotein-a-i prebeta-HDL (cer-001) promotes reverse cholesterol transport and reduces carotid wall thickness in patients with genetically-determined low HDL." Atherosclerosis 235, no. 2 (August 2014): e14. http://dx.doi.org/10.1016/j.atherosclerosis.2014.05.009.

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23

Hovingh, G. Kees, Loek P. Smits, Claudia Stefanutti, Handrean Soran, See Kwok, Jacqueline de Graaf, Daniel Gaudet, et al. "The effect of an apolipoprotein A-I–containing high-density lipoprotein–mimetic particle (CER-001) on carotid artery wall thickness in patients with homozygous familial hypercholesterolemia." American Heart Journal 169, no. 5 (May 2015): 736–42. http://dx.doi.org/10.1016/j.ahj.2015.01.008.

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24

Stroes, E., R. Benghozi, J. L. Dasseux, J. Genest, H. Ginsberg, C. Keyserling, E. Leitersdorf, P. Raggi, and A. von Eckardstein. "A phase III multicentre, double-blind, placebo-controlled study (TANGO) to evaluate CER-001 on carotid atherosclerosis (vessel wall area) in patients with familial primary hypoalphalipoproteinaemia." Atherosclerosis 252 (September 2016): e111-e112. http://dx.doi.org/10.1016/j.atherosclerosis.2016.07.609.

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25

Le, Loan, Daniel J. Schwartz, Risa Nakase-Richardson, Emily J. Almeida, William Anderson, Kevin Patel, Benjamin Sudolcan, and Sagarika Nallu. "0556 Simultaneous comparison of unedited and manually edited HSAT with level 1 PSG in persons with hospitalized TBI." SLEEP 46, Supplement_1 (May 1, 2023): A245. http://dx.doi.org/10.1093/sleep/zsad077.0556.

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Abstract Introduction Previous studies have shown automatic scoring of portable level 3 sleep study provides similar findings when compared to polysomnography (PSG), establishing home sleep apnea tests (HSAT) as an adequate screening tool for OSA. Accuracy of level 3 studies with Nox T3 portable sleep studies (Noxturna Inc., Atlanta GA) may improve with manual editing to include total sleep time (TST). No other studies have compared unedited versus manually edited HSAT with level 1 in-lab PSG performed simultaneously. This study evaluates if added manual editing optimizes the diagnostic accuracy of HSAT in classifying the severity of OSA, using both AASM and CMS criteria. Methods Secondary analysis of six-center (n=206) sleep apnea diagnostic comparative effectiveness trial. Participants underwent simultaneous administration of level 1 PSG (Philips Alice 6 LDx Diagnostic Sleep system) and Nox T3 portable sleep study with centralized scoring using AASM and CMS criteria. All HSAT were autoscored and then edited by the registered polysomnographic technician. Editing entailed establishing start and stop recording times based on accompanying actigraphy data (reduction in movement) in the portable device and elimination of recording artifact. Results Using AASM criteria, poor sensitivity OSA (AHI≥5) was observed using unedited vs PSG (p=.01) compared to manually edited HSAT vs. PSG (p=.06). No statistically significant difference was observed using AHI≥15 or via categorization across four levels of OSA (none, mild, moderate, or severe). In contrast, CMS criteria comparisons to PSG showed poor specificity of OSA (AHI≥5) for unedited (p=.003) compared to edited (p=.372) HSAT studies. As expected, total sleep time was overestimated using T3 actigraphy devices compared to the criterion standard across both edited and unedited studies (p=.001, .001 respectively). Conclusion Improvements in sensitivity and specificity of OSA were noted using edited versus unedited T3 HSAT when compared to Level 1 PSG using both AASM and CMS criteria. Results support need for manualized editing of HSAT in persons with hospitalized TBI. Support (if any) PCORI (CER-1511-33005), GDHS (W91YTZ-13-C-0015)

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Knapik, Katarzyna, Karolina Sieroń, Ewa Wojtyna, Grzegorz Onik, Ewa Romuk, Ewa Birkner, Agata Stanek, Aleksandra Kawczyk-Krupka, Ryszard Plinta, and Aleksander Sieroń. "Precompetitional Weight Reduction Modifies Prooxidative-Antioxidative Status in Judokas." Oxidative Medicine and Cellular Longevity 2019 (July 22, 2019): 1–9. http://dx.doi.org/10.1155/2019/2164698.

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Objective. The main aim of the study was an assessment of the influence of rapid weight loss on oxidative stress parameters in judokas differing in weight reduction value. Materials and Methods. The study included 30 judokas with an age range of 18-30 years (mean age: 22.4±3.40 years). Enzymatic and nonenzymatic antioxidative markers, lipid peroxidation markers, and total oxidative stress were assessed three times: one week before a competition (the first stage), after gaining the desired weight (the second stage), and one week after the competition (the third stage). Results. Between the first and the second stage, the concentration of lipid hydroperoxides (LPH) decreased significantly. The superoxide dismutase (SOD), copper- and zinc-containing superoxide dismutase (Cu,Zn-SOD), ceruloplasmin (CER), malondialdehyde (MDA), LPH, and total oxidative stress (TOS) concentrations were the lowest one week after the competition. Linear regression indicated that the emphases on increased weight reduction increased the activity of glutathione peroxidase (GPx), glutathione reductase (GR), glutathione S-transferase (GST), and protein sulfhydryl (PSH) between the first and the second stage of the study. Moderate weight reduction (2-5%) resulted in elevated levels of SOD, Mn-SOD, LPH, MDA, and TOS in comparison to low and high reductions. An opposite relation was observed in PSH. In judokas, the precompetitional weight reduction range was 0.44-6.10% (mean: 2.93%±1.76%) of the initial body weight. Concentrations of superoxide dismutase (SOD; p<.01), manganese-dependent superoxide dismutase (Mn-SOD; p<.001), and ceruloplasmin (CER; p<.05) decreased between the first and the third stage of the study as well between the second and third one. Before competitions, a decrease in lipid hydroperoxide (LPH; p<.01) concentration was observed. A reduction of malondialdehyde (MDA; p<.05), LPH (p<.01), and total oxidative stress (TOS; p<.05) levels between the first and the final stage occurred. The increase in weight reduction was linearly correlated with the rise of glutathione peroxidase (GPx; p<.05), glutathione reductase (GR; p<.05), glutathione S-transferase (GST; p<.05), and protein sulfhydryl (PSH; p<.05) concentrations between the first and the second stage of the study. Moderate weight reduction (2-5%) resulted in elevated levels of SOD (p<.05), Mn-SOD (p<.05), LPH (p<.05), MDA (p<.05), and TOS (p<.05) in comparison to low and high reductions. An opposite relation was observed in PSH (p<.005). Conclusions. The effect of weight reduction in judo athletes on prooxidative-antioxidative system diversity depends on the weight reduction value.

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Cordeiro Juliani, Fabiana, Viviane Zorzanelli Rocha, Ana Paula Marte Chacra, and Raul Dias dos Santos. "HIPOALFALIPOPROTEINEMIAS: DIAGNÓSTICO DIFERENCIAL, APRESENTAÇÃO CLÍNICA E DESAFIO TERAPÊUTICO." Revista da Sociedade de Cardiologia do Estado de São Paulo 31, no. 1 (April 1, 2021): 23–31. http://dx.doi.org/10.29381/0103-8559/2021310123-31.

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As lipoproteínas de alta densidade (HDL) compõem um grupo de partículas heterogêneas de diferentes subfrações. Na circulação, essas partículas captam o excesso de colesterol livre dos tecidos periféricos realizando o transporte do colesterol até o fígado, processo chave para a homeostase do colesterol no organismo. Inúmeras outras funções relacionadas com a prevenção e instalação do processo de aterogênese são atribuídas à HDL. Com base na “Hipótese da HDL-colesterol”, sustentada pela forte associação inversa entre os níveis do HDL-C e o risco de doença cardiovascular (DCV), a HDL recebeu destaque como um promis-sor alvo terapêutico. Contudo, estudos clínicos randomizados que testaram medicamentos capazes de aumentar a HDL-C falharam em demonstrar benefícios. A redução nos níveis do HDL-C (< 40 mg/dl) pode ocorrer de forma isolada ou em associação a outros distúrbios, como o aumento do LDL-C e/ou triglicérides, e representa uma desordem do metabolismo de lipoproteínas denominado HDL-C baixo ou hipoalfalipoproteinemia. Com frequência, os níveis baixos de HDL-C se devem a causas secundárias. Contudo, os níveis extremamente baixos do HDL-C (< 20 mg/dL), em particular quando não há hipertrigliceridemia, representam causas primárias de hipoalfalipoproteinemias, e podem decorrer de distúrbios monogênicos raros que resultam em profunda perturbação na biogênese e das vias metabólicas da HDL. É importante salientar, porém, que nem todos os defeitos que levam à deficiência grave de HDL associam-se a aumento no risco de DCV. Há perspectivas de que terapias baseadas na infusão de HDL reconstituída (HDLr) como o MDCO-216, o CSL-112 e o CER-001 possam contribuir para a redução de desfechos cardiovasculares nesses pacientes.

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Doughtie, Kara, Erica E. Fortune, Heather Badt, Caroline Lawrence, Madyson L. Popalis, and Melissa F. Miller. "Abstract P6-05-29: Experience of Financial Toxicity and Distress Among Individuals Diagnosed with Triple Negative Breast Cancer: Findings from the Cancer Experience Registry." Cancer Research 83, no. 5_Supplement (March 1, 2023): P6–05–29—P6–05–29. http://dx.doi.org/10.1158/1538-7445.sabcs22-p6-05-29.

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Abstract Background: Financial toxicity associated with cancer and its treatment can negatively impact treatment adherence and quality of life. Individuals with triple negative breast cancer (TNBC) may be at increased risk for financial toxicity due to the aggressive nature of the disease and high rate of recurrence. The objective of this study was to characterize financial experiences of TNBC survivors, their descriptions of communication with providers concerning treatment costs, and correlations between financial toxicity and psychosocial distress. Methods: From July 2017 to August 2021, 94 individuals with TNBC took part in Cancer Support Community’s Cancer Experience Registry® (CER). Participants completed items related to financial distress, including COmprehensive Score for Financial Toxicity (COST), an 11-item (0=Not at all, 4=Very much) measure of financial well-being (range 0-44; lower scores indicate worse financial well-being), dichotomous (yes or no) items assessing patient-provider communication, and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29 v2.0). Bivariate relations were assessed using Pearson’s correlation. Results: Participants were 81% non-Hispanic White, 6% Black, and 6% Hispanic. Mean age was 52 years (SD=11.3); 14 (15%) reported household income <$40K. Median time since diagnosis was 2 years; 15% (n=14) reported metastatic breast cancer and 36% were currently receiving treatment. Concerning out-of-pocket cancer-related costs, 56% of our sample reported spending >$250 per month; 32% >$500; 13% >$1000. To reduce costs, 23% sometimes, often, or always postponed seeking psychological support, 19% delayed follow-up on recommendations, 6% postponed doctor’s appointments, and 5% skipped medication. The mean COST score was 23.0 (SD=12.3), indicating mild financial distress overall. Less than half of the sample (46%) indicated no financial toxicity (scores >25), 29% mild financial toxicity (scores 14-25), 22% moderate (score 1-13), and 3% severe (score of 0). The frequency of individual COST items showed 61% reported (somewhat, quite a bit, or very much) worry about future financial problems due to treatment costs; 14% were unable to meet monthly expenses; 49% reported concern about keeping their job or income; 47% reported frustration that they could not work or contribute as usual. COST scores were inversely correlated to PROMIS anxiety (r=-.45, p<.001), depression (r=-.44, p<.001), and sleep disturbance subscales (r=-.48, p<.001), such that lower financial well-being related to more symptomology. COST scores were positively associated with the social function subscale (r=.46, p<.001), so that better financial well-being related to higher social functioning. Regarding patient-provider communication, 70% reported their health care team did not discuss costs, 62% did not discuss impact of TNBC and treatment on work, and 59% did not discuss financial concerns. One-third (34%) wished they received more financial advice and assistance. Conclusion: In this sample of TNBC patients, average levels of financial toxicity were in the mild range. However, many reported moderate to severe toxicity (25%). Greater financial toxicity related to increased symptoms of anxiety, depression, sleep disturbance, and worse social functioning. Despite this, results indicate there is little patient-provider discussion about financial burden, with more than half of our sample reporting their health care team did not discuss costs, impact on work, or financial distress. One-third of participants indicated desire for more financial advice and assistance highlighting an opportunity to better serve TNBC patients, who may be at an increased risk of financial toxicity. Citation Format: Kara Doughtie, Erica E. Fortune, Heather Badt, Caroline Lawrence, Madyson L. Popalis, Melissa F. Miller. Experience of Financial Toxicity and Distress Among Individuals Diagnosed with Triple Negative Breast Cancer: Findings from the Cancer Experience Registry [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-29.

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Kuandykova, Elvira, Bakhitzhan Kuandykov, Sabit Daubassov, Manshuk Beysenbaeva, Duman Kussainov, and Bayan Ashyralieva. "Legal basis of international agricultural organizations." RIVISTA DI STUDI SULLA SOSTENIBILITA' 13, no. 1 (November 2023): 217–31. http://dx.doi.org/10.3280/riss2023-001-s1014.

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Contractual relations between various agricultural producers and other legal entities act as one of the priority areas in research carried out in the field of agro-industrial legislation. The study of specific areas of their activities, the goals they set for them- selves, the array of documentation developed by them, the effectiveness of their work, the presence or absence of interaction with other international structures. There is a detailed analysis of those trends that have generated the need for interstate cooperation and interaction in the field of countering the problems that have arisen in the agricultural sector of the world economy, as well as a set of methods by which these problems are solved. The information that will be presented in this article is applicable as reference, additional information at the state and interstate level of cer- tain activities that are aimed at forming a policy for interaction with both state and non-governmental actors of the world community in the agricultural, agricultural sector.

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Strobel, Sabine, and Thomas Schleid. "Quaternäre Strontium-Kupfer(I)-Lanthanoid(III)-Selenide mit Cer und Praseodym: SrCuCeSe3 und SrCuPrSe3, ein ungleiches Geschwisterpaar / Quaternary Strontium Copper(I) Lanthanoid(III) Selenides with Cerium and Praseodymium: SrCuCeSe3 and SrCuPrSe3, Unequal Brother and Sister." Zeitschrift für Naturforschung B 59, no. 9 (September 1, 2004): 985–91. http://dx.doi.org/10.1515/znb-2004-0907.

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Quaternary strontium copper(I) lanthanoid(III) selenides are formed by the oxidation of elemental strontium, copper and the corresponding lanthanoid with selenium. Orange to red needle-shaped single crystals of SrCuPrSe3 and SrCuCeSe3 have been synthesized by heating mixtures of Sr, Cu, Pr / Ce and Se with CsI as a flux in evacuated silica tubes to 800°C for 7 d. Both compounds crystallize orthorhombically in space group Pnma with four formula units per unit cell, but with unlike lattice constants (a = 1097.32(6), b = 416.51(2), c = 1349.64(8) pm for SrCuPrSe3 and a = 846.13(5), b = 421.69(2), c = 1663.42(9) pm for SrCuCeSe3) and therefore different structure types. The Pr3+ cations in SrCuPrSe3 are surrounded octahedrally by six Se2− anions forming chains of edge-sharing [PrSe6]9− octahedra that are joined by common vertices. Together with [CuSe4]7− tetrahedra they form [CuPrSe3]2− layers piled up parallel (001). Between those layers the Sr2+ cations are coordinated by seven Se2− anions in the shape of capped trigonal prisms linking the structure in the third dimension. On the other hand in SrCuCeSe3 the Ce3+ cations as well as the Sr2+ cations adopt a coordination number of seven. Since the bonding distances between cerium and selenium match with those of strontium and selenium the two crystallographically independent sites of these cations are occupied statistically by Ce3+ and Sr2+ with equal ratios. Nevertheless, there is a close structural relationship between SrCuPrSe3 and SrCuCeSe3. Similar to SrCuPrSe3 where Cu+ and Pr3+ cations together with Se2− anions form [CuPrSe3]2− layers parallel (001), the Cu+ cations and [(Ce1/Sr1)Se7]11.5− polyhedra in SrCuCeSe3 build strongly puckered layers which are connected by (Ce2)3+/(Sr2)2+ cations. The copper selenium part in both compounds correlates as well, with [CuSe4]7− tetrahedra linked by common vertices to form [CuSe3]5− chains running along [010].

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Goffinet, Marine, Claudine Tardy, Alice Bluteau, Nadia Boubekeur, Rudi Baron, Constance Keyserling, Ronald Barbaras, Narendra Lalwani, and Jean-Louis Dasseux. "Abstract 18667: Anti-atherosclerotic Effect of CER-001, an Engineered HDL-mimetic, in the High-fat Diet-fed LDLr Knockout Mice." Circulation 126, suppl_21 (November 20, 2012). http://dx.doi.org/10.1161/circ.126.suppl_21.a18667.

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CER-001 is an engineered HDL-mimetic, comprised of recombinant human ApoA I and phospholipid, exhibiting properties of nascent pre-ß HDL. Intravenous infusion of CER-001 promotes reverse lipid transport by causing rapid mobilization of cholesterol in animals, including in man. Previous studies have shown that CER-001 induced cholesterol efflux from macrophages similar to HDL3 in vitro, enhanced LCAT activity, and exhibited anti-inflammatory response similar to natural HDL. The aim of this study was to evaluate the effect of CER-001 on atherosclerotic plaques in high-fat diet-fed LDL-receptor -/- mice. Mice on high-fat diet for 10 weeks were given CER-001, 10 mg/Kg, intravenously. Aortic plaques were evaluated by immunohistochemistry following 5 or 10 doses given every second day. CER-001 caused 22.5% (p=0.02) and 32% (p= 0.009) reductions in plaque size, and 14% (p=0.08) and 23% (p=0.03) reductions in lipid content following a treatment regimen of 5 and 10 doses, respectively. Also, there was an 80% reduction in macrophage content in the plaque following 5 doses, as shown by F4/80 staining (p=0.0001), suggesting decreased inflammation. These data suggest that CER-001, an HDL-mimetic, could be a suitable therapeutic for the treatment of atherosclerosis and associated vascular complications, including in familial hypercholesterolemia patients.

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Stasi, Alessandra, Marco Fiorentino, Rossana Franzin, Francesco Staffieri, Sabrina Carparelli, Rosa Losapio, Alberto Crovace, et al. "Beneficial effects of recombinant CER-001 high-density lipoprotein infusion in sepsis: results from a bench to bedside translational research project." BMC Medicine 21, no. 1 (November 2, 2023). http://dx.doi.org/10.1186/s12916-023-03057-5.

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Abstract Background Sepsis is characterized by a dysregulated immune response and metabolic alterations, including decreased high-density lipoprotein cholesterol (HDL-C) levels. HDL exhibits beneficial properties, such as lipopolysaccharides (LPS) scavenging, exerting anti-inflammatory effects and providing endothelial protection. We investigated the effects of CER-001, an engineered HDL-mimetic, in a swine model of LPS-induced acute kidney injury (AKI) and a Phase 2a clinical trial, aiming to better understand its molecular basis in systemic inflammation and renal function. Methods We carried out a translational approach to study the effects of HDL administration on sepsis. Sterile systemic inflammation was induced in pigs by LPS infusion. Animals were randomized into LPS (n = 6), CER20 (single dose of CER-001 20 mg/kg; n = 6), and CER20 × 2 (two doses of CER-001 20 mg/kg; n = 6) groups. Survival rate, endothelial dysfunction biomarkers, pro-inflammatory mediators, LPS, and apolipoprotein A-I (ApoA-I) levels were assessed. Renal and liver histology and biochemistry were analyzed. Subsequently, we performed an open-label, randomized, dose-ranging (Phase 2a) study included 20 patients with sepsis due to intra-abdominal infection or urosepsis, randomized into Group A (conventional treatment, n = 5), Group B (CER-001 5 mg/kg BID, n = 5), Group C (CER-001 10 mg/kg BID, n = 5), and Group D (CER-001 20 mg/kg BID, n = 5). Primary outcomes were safety and efficacy in preventing AKI onset and severity; secondary outcomes include changes in inflammatory and endothelial dysfunction markers. Results CER-001 increased median survival, reduced inflammatory mediators, complement activation, and endothelial dysfunction in endotoxemic pigs. It enhanced LPS elimination through the bile and preserved liver and renal parenchyma. In the clinical study, CER-001 was well-tolerated with no serious adverse events related to study treatment. Rapid ApoA-I normalization was associated with enhanced LPS removal and immunomodulation with improvement of clinical outcomes, independently of the type and gravity of the sepsis. CER-001-treated patients had reduced risk for the onset and progression to severe AKI (stage 2 or 3) and, in a subset of critically ill patients, a reduced need for organ support and shorter ICU length of stay. Conclusions CER-001 shows promise as a therapeutic strategy for sepsis management, improving outcomes and mitigating inflammation and organ damage. Trial registration The study was approved by the Agenzia Italiana del Farmaco (AIFA) and by the Local Ethic Committee (N° EUDRACT 2020–004202-60, Protocol CER-001- SEP_AKI_01) and was added to the EU Clinical Trials Register on January 13, 2021.

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Barbaras, Ronald. "Non-clinical development of CER-001." Frontiers in Pharmacology 6 (October 6, 2015). http://dx.doi.org/10.3389/fphar.2015.00220.

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Stasi, Alessandra, Rossana Franzin, Marco Fiorentino, Francesco Staffieri, Rosa Losapio, Maria Teresa Cimmarusti, Alberto Crovace, et al. "#4015 RECOMBINANT HIGH-DENSITY LIPOPROTEIN MODULATES INFLAMMATORY RESPONSE AND RENAL DYSFUNCTION IN A SWINE MODEL OF SEPSIS-INDUCED ACUTE KIDNEY INJURY." Nephrology Dialysis Transplantation 38, Supplement_1 (June 2023). http://dx.doi.org/10.1093/ndt/gfad063a_4015.

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Abstract Background and Aims Sepsis is a severe and dysregulated inflammatory disease that often precedes the development of acute kidney injury (AKI) with consequent worsening outcome. Although clinical data demonstrate that high-density lipoprotein (HDL) levels drop in septic patients with a poor prognosis, little is known about the molecular basis of HDL's role in systemic inflammation and renal function. Here we investigate the possible effects of a novel engineered HDL-mimetic (CER-001) in a swine model of lipopolysaccharide (LPS)-induced AKI. Method Sepsis was induced by intravenous infusion of a saline solution containing 300 μg/kg of LPS in a porcine model. The animals were randomized into three groups: LPS (endotoxemic pigs, n = 6), CER20 (endotoxemic pigs treated with a single dose of CER-001 20mg/kg; n = 6), and CER20 × 2 (endotoxemic pigs treated with two doses of CER001 20mg/kg; n = 6). Animals were sacrificed after 24h from the start of experimental procedure. Renal histologic and biochemical changes were analyzed. Endothelial dysfunction biomarkers, circulating pro-inflammatory mediators, LPS and Apolipoprotein A-I (Apo A-I) levels were quantified with ELISA assay. Systemic complement activation was evaluated by Wieslab kit. Results Untreated animals were highly susceptible to LPS challenge and usually succumbed before completing the study protocol (LPS group 16.7%). CER-001 treatment increased the survival rate of endotoxemic pigs, compared to the LPS group (CER20, 50%; CER20 × 2, 66.7%). Furthermore, as shown in Figure 1A, LPS injection led to a time-dependent increase of IL-6 in endotoxemic animals respect to basal condition (T0). CER-001 treatment was able to reverse LPS effects. In particular, the second infusion of CER-001 three hours after the first dose (T3) strongly reduced IL-6 serum levels back to basal level (LPS p <0.05). Similarly, we found high levels of TNF-α and MCP-1 in endotoxemic pigs that were significantly decreased in both CER-001 treatment arms (T24, CER20 × 2 vs LPS group, IL-6, p = 0.0086; TNF-α, p<0.0001; MCP-1, p = 0.0009). In addition, CER-001 treatment ameliorated systemic endothelial dysfunction by reducing VCAM and ICAM serum levels. A significant activation of classical and alternative complement pathway (vs T0 p <0.05) was observed at 1h, 3h and 24h after LPS infusion. CER001 treatment significantly prevented systemic complement activation in both treated groups (vs LPS p <0.05). We also investigated whether CER001 infusions significantly prevented renal tissue damage. Endotoxemic pigs presented oliguric AKI with increased tubulo-interstitial infiltrate, extensive collagen deposition, and glomerular thrombi; CER-001 treatment preserved renal parenchyma, recovered urine output, decreased creatine levels, and reduced the biomarkers of tubular damage, Cystatin C and KIM-1, both in serum and urine samples. Considering that HDL has a very high affinity for LPS, we evaluated the circulating LPS concentration in treated animals. We observed that LPS levels were greatly reduced in treated animals and the effects are more evident after the second infusion of CER-001(Figure 1B). Therefore, we also examined LPS levels in bile samples and we observed a dose-dependent increasing amount of endotoxin in the CER001 treated septic pigs. Conclusion This preclinical data indicates that CER001 treatment prevents systemic inflammation thereby limiting renal damage. The mechanism of action is two-fold consisting of both the scavenging of endotoxin and a direct anti-inflammatory effect of CER-001.

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Kalayci, Arzu, C. Michael Gibson, Paul M. Ridker, Samuel D. Wright, Bronwyn A. Kingwell, Serge Korjian, Gerald Chi, et al. "ApoA-I Infusion Therapies Following Acute Coronary Syndrome: Past, Present, and Future." Current Atherosclerosis Reports, May 7, 2022. http://dx.doi.org/10.1007/s11883-022-01025-7.

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Abstract Purpose of Review The elevated adverse cardiovascular event rate among patients with low high-density lipoprotein cholesterol (HDL-C) formed the basis for the hypothesis that elevating HDL-C would reduce those events. Attempts to raise endogenous HDL-C levels, however, have consistently failed to show improvements in cardiovascular outcomes. However, steady-state HDL-C concentration does not reflect the function of this complex family of particles. Indeed, HDL functions correlate only weakly with serum HDL-C concentration. Thus, the field has pivoted from simply raising the quantity of HDL-C to a focus on improving the putative anti-atherosclerotic functions of HDL particles. Such functions include the ability of HDL to promote the efflux of cholesterol from cholesterol-laden macrophages. Apolipoprotein A-I (apoA-I), the signature apoprotein of HDL, may facilitate the removal of cholesterol from atherosclerotic plaque, reduce the lesional lipid content and might thus stabilize vulnerable plaques, thereby reducing the risk of cardiac events. Infusion of preparations of apoA-I may improve cholesterol efflux capacity (CEC). This review summarizes the development of apoA-I therapies, compares their structural and functional properties and discusses the findings of previous studies including their limitations, and how CSL112, currently being tested in a phase III trial, may overcome these challenges. Recent Findings Three major ApoA-I-based approaches (MDCO-216, CER-001, and CSL111/CSL112) have aimed to enhance reverse cholesterol transport. These three therapies differ considerably in both lipid and protein composition. MDCO-216 contains recombinant ApoA-I Milano, CER-001 contains recombinant wild-type human ApoA-I, and CSL111/CSL112 contains native ApoA-I isolated from human plasma. Two of the three agents studied to date (apoA-1 Milano and CER-001) have undergone evaluation by intravascular ultrasound imaging, a technique that gauges lesion volume well but does not assess other important variables that may relate to clinical outcomes. ApoA-1 Milano and CER-001 reduce lecithin-cholesterol acyltransferase (LCAT) activity, potentially impairing the function of HDL in reverse cholesterol transport. Furthermore, apoA-I Milano can compete with and alter the function of the recipient’s endogenous apoA-I. In contrast to these agents, CSL112, a particle formulated using human plasma apoA-I and phosphatidylcholine, increases LCAT activity and does not lead to the malfunction of endogenous apoA-I. CSL112 robustly increases cholesterol efflux, promotes reverse cholesterol transport, and now is being tested in a phase III clinical trial. Summary Phase II-b studies of MDCO-216 and CER-001 failed to produce a significant reduction in coronary plaque volume as assessed by IVUS. However, the investigation to determine whether the direct infusion of a reconstituted apoA-I reduces post-myocardial infarction coronary events is being tested using CSL112, which is dosed at a higher level than MDCO-216 and CER-001 and has more favorable pharmacodynamics.

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Franzin, Rossana, Alessandra Stasi, Marco Fiorentino, Fabio Sallustio, Ronald Barbaras, Connie Peyrottes, Cyrille Tupin, Giuseppe Castellano, Paola Pontrelli, and Loreto Gesualdo. "MO287: A Recombinant BIO-HDL (CER-001) Can Prevent SARS-COV2-Induced Renal Dysfunction by Restoring SR-BI Signalling." Nephrology Dialysis Transplantation 37, Supplement_3 (May 2022). http://dx.doi.org/10.1093/ndt/gfac067.086.

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Abstract BACKGROUND AND AIMS Replication of the enveloped SARS-COV2 virus can alter lipidomic composition and metabolism of infected cells [1]. These alterations commonly result in a decline in HDL, total cholesterol and LDL, and an increase in triglyceride levels in COVID-19 patients. Furthermore, the ‘cytokine storm’ subsequent to release of inflammatory cytokines can severely impair lipid homeostasis. Importantly, decreased HDL-cholesterol correlates with severity of COVID-19 infection and represents a significant prognostic factor in predicting poor clinical outcomes [2]. Similarly, it has been observed that COVID-19 patients’ recovery is accompanied by a rise in serum HDL levels. Pharmacological intervention that aims to restore ApoA-1 or functional HDL particles may have beneficial roles for clinical outcome of COVID-19 patients and has recently been approved for compassionate use [3]. SARS-CoV 2 spike proteins S1 and S2 can bind free cholesterol and HDL-bound cholesterol, facilitating virus entry by binding the ACE2 co-receptor Scavenger Receptor-BI (SR-BI) [4]. When activated at the trans-membrane level, SR-BI signalling culminates in Ser1173-eNOS phosphorylation with both anti-inflammatory and anti-apoptotic effect. We hypothesized that SARS-COV2 binding promoted SR-BI internalization, so that it could not exert its essential protective function. Therefore, the aim of this study is to evaluate the effects of CER-001, a mimetic HDL, in antagonizing this process. METHOD Endothelial and tubular (RPTEC) cells were exposed to S1, S2 and S1 + S2 (50–250 nM) with or without CER-001 (CER-001 50–500 ug/mL) and cholesterol (10–50 uM). Apoptosis tests (MTT and AnnV/PI) were performed. Internalization of SR-BI, ACE2 with S1 and activation of eNOS was evaluated by FACS analysis. SR-BI and ACE2 expression were evaluated on kidney biopsies from COVID-19 patients. RESULTS At concentrations used, the exposition of S1, S2 and S1 + S2 in the presence of CER-001 and cholesterol did not induce apoptosis of endothelial cells and RPTEC. Endothelial and tubular cells stimulated by S1, in presence of cholesterol, showed an increased intracellular level of SR-BI and ACE-2, with significantly reduced eNOS phosphorylation compared to baseline (P < 0.05). The treatment with CER-001 reversed trans-membrane SR-BI levels and eNOS phosphorylation to baseline values. The detection of S1 spike protein by endothelial cells immunohistochemistry revealed an increased level in S1-exposed cells with cholesterol and reduced S1 intracellular positive staining in CER-001-exposed cells (P < 0.05). Interestingly, S1-exposed cells without cholesterol appeared not to be capable of mediating S1 spike protein internalization. Consistent with in vitro results, analysis of renal biopsies from COVID-19 patients with proteinuria showed increased SR-BI and ACE-2 cytoplasmic signals and reduced expression at the apical domain of injured tubules. CONCLUSION Our data confirmed the key role of lipid profile in SARS-COV2 infection, evaluating the molecular signalling involved in HDL metabolism and inflammatory processes, and could offer new therapeutic strategies for COVID-19 patients.

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Kataoka, Yu, Jordan Andrews, MyNgan Duong, Tracy Nguyen, Nisha Schwarz, Jessica Fendler, Rishi Puri, et al. "Abstract 12156: Greater Regression of Coronary Atherosclerosis With the Pre-Beta High-Density Lipoprotein Mimetic CER-001 in Patients With More Extensive Plaque Burden." Circulation 132, suppl_3 (November 10, 2015). http://dx.doi.org/10.1161/circ.132.suppl_3.12156.

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Introduction: Infusing high-density lipoprotein (HDL) has been shown to promote plaque regression in patients with acute coronary syndrome (ACS). The factors associated with a greater propensity to regression have not been elucidated. We hypothesized greater plaque regression with HDL infusion would be observed in patients with greater baseline plaque burden. Methods: The CHI-SQUARE study compared the effect of infusing the pre-beta HDL mimetic CER-001 (3 to 12 mg/kg) versus placebo weekly for 5 weeks in patients with a recent ACS on plaque burden using serial intravascular ultrasound. Receiver operating characteristics curve analysis determined that a baseline percent atheroma volume (PAV) ≥30% optimally associated with greater regression. Clinical and imaging characteristics were compared in patients with baseline PAV <30% (n=74) or ≥30% (n=271). Results: There were no differences between the groups apart from greater use of statin in patients with baseline PAV ≥30% (100 v. 90%, p=0.01). Patients with a greater baseline PAV were more likely to demonstrate echolucency (20 v. 9%, p=0.02) and ultrasound attenuation (21 v. 7%, p=0.01), consistent with lipidic and inflammatory material. On serial evaluation, PAV decreased with CER-001 infusion in patients with baseline PAV ≥30% by -0.27% (p=0.01 v. baseline), but not in those with baseline PAV <30% (+0.43%, p=0.15 v. baseline, p=0.01 between plaque burden groups). The greatest PAV regression was observed with infusing CER-001 3 mg/kg in patients with baseline PAV ≥30% by 0.96% (p=0.04 v. baseline, p=0.02 v. placebo) (Table), but not in those patients with baseline PAV <30% (+0.08%, p=0.55 v. baseline, p=0.004 for comparison between plaque burden groups). Conclusions: Greater plaque regression with CER-001 3 mg/kg was observed in ACS patients with greater atheroma burden and more vulnerable features. The findings identify ACS patients with high-risk plaque features most likely to benefit from HDL mimetic therapy.

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Faguer, Stanislas, Arnaud Del Bello, Chloé Danet, Yves Renaudineau, Jacques Izopet, and Nassim Kamar. "Apolipoprotein-A-I for severe COVID-19-induced hyperinflammatory states: A prospective case study." Frontiers in Pharmacology 13 (September 26, 2022). http://dx.doi.org/10.3389/fphar.2022.936659.

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Viral infections can promote cytokine storm and multiorgan failure in individuals with an underlying immunosuppression or specific genetic background. Hyperinflammatory states, including critical forms of COVID-19, are characterized by a remodeling of the lipid profile including a dramatic decrease of the serum levels of apolipoprotein-A-I (ApoA-I), a protein known for its capacity to reduce systemic and lung inflammation, modulate innate and adaptive immunity, and prevent endothelial dysfunction and blood coagulation. In this study, four immunocompromised patients with severe COVID-19 cytokine storm that progressed despite standard-of-care therapy [Omicron (n = 3) and Delta (n = 1) variants] received 2– 4 infusions (10 mg/kg) of CER-001, an ApoA-I-containing HDL mimetic. Injections were well-tolerated with no serious adverse events. Three patients treated while not on mechanical ventilation had early clinical and biological improvement (oxygen withdrawal and correction of hematological and inflammatory parameters, including serum levels of interleukin-8) and were discharged from the hospital 3–4 days after CER-001 infusions. In the fourth patient who received CER-001 after orotracheal intubation for acute respiratory distress syndrome, infusions were followed by transient respiratory improvement before secondary worsening related to ventilation-associated pneumonia. This pilot uncontrolled exploratory compassionate study provides initial safety and proof-of-concept data from patients with a COVID-19 cytokine storm receiving ApoA-I. Further randomized controlled trial evaluation is now required to ascertain whether ApoA-I has any beneficial effects on patients with a COVID-19 cytokine storm.

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Woodall, J. M. "Contactless Electromodulation Characterization of Compound Semiconductor Surfaces and Device Structures." MRS Proceedings 324 (1993). http://dx.doi.org/10.1557/proc-324-141.

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AbstractThis paper will review the use of contactless electromodulation methods, such as photoreflectance (PR) and contactless electroreflectance (CER), to characterize the electronic properties of compound semiconductor surfaces exposed to different growth and post-growth conditions. Also the characterization of properties critical to device performance can be evaluated. For example, using PR and CER it has been found that there is a lower density of surface hole traps than electron traps in certain as-grown MBE (001) GaAs samples and that this condition persists even after air exposure. This behaviour is in contrast to other samples, including both bulk and MBE grown (001) surfaces in which the Fermi level is pinned mid-gap for both n- and p-type structures. We also have observed that Ar+ bombardment under UHV conditions results in Fermi level pinning close to the conduction band edge and that thermal annealing restores mid-gap pinning. Finally, using PR we are able to characterize the electric fields and associated doping levels in the emitter and collector regions of heterojunction bipolar transistor structures (fabricated from III-V materials), thus demonstrating the ability to perform inprocess evaluation of important device parameters.

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Ossoli, Alice, Arianna Strazzella, Daniela Rottoli, Cristina Zanchi, Monica Locatelli, Carlamaria Zoja, Sara Simonelli, et al. "CER-001 ameliorates lipid profile and kidney disease in a mouse model of Familial LCAT Deficiency." Metabolism, December 2020, 154464. http://dx.doi.org/10.1016/j.metabol.2020.154464.

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Romero, Natividad Calvo, Jesús Domínguez Delgado-Palacios, Marta Calvo Arevalo, Isabel Pérez-Flores, Beatriz Rodríguez Cubillo, María Ángeles Moreno de la Higuera Díaz, María Muñiz Rincón, Arianne Aiffil Meneses, Rómulo Katsu Loayza López, and Ana Sanchez Fructuoso. "#5146 KINETIC ESTIMATION OF GFR AND URINARY CREATININE EXCRETION RATE AS PREDICTORS OF DELAYED GRAFT FUNCTION IN RENAL TRANSPLANTS FROM DECEASED DONORS." Nephrology Dialysis Transplantation 38, Supplement_1 (June 2023). http://dx.doi.org/10.1093/ndt/gfad063c_5146.

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Abstract Background and Aims Delayed graft function (DGF) is a common complication after renal transplant. Definitions of DGF are based on analysis of estimated glomerular filtration rate (eGFR) underlying the plasma creatinine fluctuations after renal transplant. We tried to validate an early parameter of DGF in a renal transplant population based on the kinetic estimation of glomerular filtration rate, since this formula adds a quantitative dimension to the assessment of kidney function, and consequently predicting DGF could get a better post-transplant management. Method This is a longitudinal study of 886 renal transplant recipients from our center during the first post-transplant month. As we are searching for functional biochemical markers in renal transplant from decesased donors, we excluded patients with primary gtaft disfunction.The final simple was composed of 574 adult kidney transplant recipients, 348 renal transplant from donors after circulatory death (DCD) and 226 from donors after brain death (DBD). The following are analyzed 5creatinine concentrations, serum Lactate dehydrogenase (LDH) and urinary creatinine excretion rate (CER). Results In DCD there was a significant correlation between DGF duration and all KeGFR and CER determinations during the first post-transplant week. The parameters that achieved the best correlation to predict DGF were KeGFR (r = 0.515; p<0.001) and CER on the fourth day (r = 0.584; p<0.001) (Figure 1). In the DBD, a weak correlation was observed between DGF duration and KeGFR determinations in the first days, being KeGFR at the fourth day the one that presented the highest correlation (r = 0.59 p<0.001). We observed that serum LDH on the first day in the DBD group is associated with worse renal graft function at first, third month and one year after transplantation (p<.045, p<.05 and p<.067 respectively). Conclusion The determination of KeGFR and CER could predict the duration of DGF, especially in DCD recipients. DCD recipients with DGF have significantly better graft survival at one year than DBD recipients with DGF. (p<.001).

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Qing, Shuiwang, Lei Gu, Tingting Du, Xiaolan Yin, Ke-jia Zhang, and Huo-jun Zhang. "A Predictive Model to Evaluate Pathologic Complete Response in Rectal Adenocarcinoma." Technology in Cancer Research & Treatment 22 (January 2023). http://dx.doi.org/10.1177/15330338231202893.

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Introduction: Neoadjuvant chemo-radiotherapy (nCRT) before surgery was a standard treatment strategy for locally advanced rectal cancer (LARC). The aim of this study was to assess the relationship between the predictive factors and pathological complete response (pCR) in rectal cancer patients, especially in ultra-low ones. Method: A total of 402 patients were involved in this retrospective study. The logistic regression analyses were used to compare the different subgroups in univariate analysis. Multivariate analysis was performed to determine the independent predictive factors of pCR by using a logistic regression model. Results: A total of 402 patients received preoperative CRT. In all patients, multivariate analysis revealed that circumferential tumor extent rate (CER) (≤ 2/3cycle vs >2/3 cycle, P < .001, OR = 4.834, 95% CI: 2.309-10.121), carcinoembryonic antigen (CEA) level (both ≤ 5 vs pre > 5 and post ≤ 5 vs both > 5, P = .033, OR = 1.537, 95% CI: 1.035-2.281), and interval time between the end of CRT and surgery ( P = .031, OR = 2.412, 95% CI: 1.086-5.358) were predictive factors for pCR. The area under the curve (AUC) of the predictive model was 0.709 (95% CI: 0.649-0.769), which was significantly higher than the CER (0.646, 95% CI: 0.584-0.709), interval time (0.563, 95% CI: 0.495-0.631) and CEA level (0.586, 95% CI: 0.518-0.655). In ultra-low rectal patients, multivariate logistic regression analysis revealed that CER (≤ 2/3 cycle vs > 2/3 cycle, P = .003, OR = 7.203, 95% CI: 1.934-26.823) and mismatch repair (MMR) status (pMMR vs dMMR, P = .016, OR = 0.173, 95% CI: 0.041-0.720) were predictive factors for pCR. The AUC of the predictive model was 0.653 (95% CI: 0.474-0.832). Conclusion: New predictive models were varied by the histologic types and MMR statuses to evaluate the trend of tumor response to nCRT in all RC cases and ultra-low RC patients, which may be used to individualize stratify for selected LARC patients.

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Goto, Ken, Tomo Ueno, and Yoshinao Kumagai. "Heterostructure formation of group-III sesquioxides via cation-exchange reactions with metal chloride gases." AIP Advances 13, no. 8 (August 1, 2023). http://dx.doi.org/10.1063/5.0143736.

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Thermodynamic analyses and experimental demonstrations were performed to investigate whether cation-exchange reactions (CERs) with metal chloride gases are a feasible technique for forming heterostructures of group-III sesquioxides. The thermodynamic analyses revealed the possibility of formation of aluminum oxide (Al2O3) layers on gallium oxide (Ga2O3) or indium oxide (In2O3) substrates via CERs with aluminum chloride gases, as well as formation of Ga2O3 layers on In2O3 substrates via CERs with gallium chloride gases, in a practical temperature range. However, CERs with gallium chloride gases or indium chloride gases did not occur on Al2O3 substrates, suggesting that heterostructures were not formed. On the basis of the results of the thermodynamic analyses, a CER was performed by the reaction of n-type β-Ga2O3(2̄01) substrates with aluminum trichloride gas, resulting in the formation of Al2O3 layers. Under optimal conditions, a dense (001)-oriented κ-Al2O3 layer with a thickness of 30 nm was formed and served as an excellent gate oxide in metal–oxide–semiconductor devices. The relative dielectric constant of κ-Al2O3 was obtained via capacitance–voltage measurements, and a high value of ∼22 was obtained in the several tens of kHz band. CERs using metal chloride gases open a new method for forming heterostructures of group-III sesquioxides.

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Srivastava, Rai Ajit K., Angelo B. Cefalu, Davide Noto, Donata Panno, Antonella Giammanco Giammanco, and Maurizio R. Averna. "Abstract 9805: Lack of Correlation Between HDL Level and Fecal Cholesterol in Multiple Mouse Models Suggests Importance of HDL Functionality in Atherosclerosis Attenuation." Circulation 132, suppl_3 (November 10, 2015). http://dx.doi.org/10.1161/circ.132.suppl_3.9805.

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To circumvent the residual cardiovascular disease burden in patients receiving statin therapy, HDL-raising was suggested as a plausible approach. However, lack of benefits of CETP inhibitors, Torcetrapib and Dalcetrapib, despite substantial increase in HDL, and lack of efficacy of CER-001, an apoA-I mimetic, proved disappointing. Paradoxically, apoA-I Milano subjects with low HDL have reduced CVD risk. These findings shifted the focus from HDL level to HDL function. Promoting reverse cholesterol transport (RCT) is one of the main functions of HDL, which is measured in an in vivo assay as macrophage-derived fecal 3H-cholesterol. Non-radioisotopic method to quantitate fecal cholesterol (chol) as an RCT index was found to correlate with macrophage radioisotopic method in mice. Using this method, we carried out a number of studies in several mouse models, including C57Bl, apoA-I-Tg, LDLr KO, and ob/ob, using tool compounds, LXR and PPAR-α agonists, known to enhance RCT. Animals were treated with LXR and PPAR-α agonists alone or in combination, and lipid profile, HDL level, serum chol efflux, fecal chol, and, in appropriate animal models, aortic lipid contents were measured. In C57Bl mice, LXR agonist, T1317, raised HDL by 30%, while feno decreased HDL by 30%, but fecal chol showed a 2-fold increase in both cases. Interestingly, combination (comb) treatment with LXR and PPAR-α agonists did not change HDL, but fecal chol increased by 4.5-fold. HDL in apoA-I-Tg mice increased by 40%, 80%, and 80% in LXR, PPAR-α, and comb treated groups; respective fecal chol increases were 1.8, 1.8, and 5-fold, suggesting a lack of correlation between HDL level and fecal chol. LXR, PPAR-α, and comb-treated ob/ob mice showed 40%, 35%, and 40% rise in HDL, but 3-, 3-, and 20-fold increases in fecal chol, respectively. No correlations in HDL level and fecal chol contents were noticed in LDLr KO mice as well. Atherosclerosis attenuation by LXR and PPAR-α agonists in LDLr KO and ob.ob/LDLr DKO mice was associated with increased fecal chol, but not HDL level. These data suggest: a) a lack of correlation between HDL level and fecal chol; b) synergistic effect of LXR and PPAR-α agonists on RCT; c) reduced lesion area associated with increased fecal chol; and d) RCT influenced by additional mechanisms.

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Doebele, Robert C., Laura Perez, Huong Trinh, Michael Martinec, Reynaldo Martina, Todd Riehl, Matthew G. Krebs, Neal J. Meropol, William B. Wong, and Gracy Crane. "Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC." Journal of Comparative Effectiveness Research, August 24, 2021. http://dx.doi.org/10.2217/cer-2021-0131.

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Aim: Generating direct comparative evidence in prospective randomized trials is difficult for rare diseases. Real-world cohorts may supplement control populations. Methods: Entrectinib-treated adults with advanced ROS1 fusion-positive NSCLC (n = 94) from Phase I/II trials (ALKA-372-001 [EudraCT2012-00148-88], STARTRK-1 [NCT02097810], and STARTRK-2 [NCT02568267]) were compared with a real-world crizotinib-treated cohort (n = 65). Primary end point, time-to-treatment discontinuation (TTD); secondary end points, PFS and OS. Results: Median (95% CI) weighted TTD: 12.9 (9.9–17.4) months for entrectinib; 8.8 (6.2–9.9) months for crizotinib (weighted hazard ratio, 0.72 [0.51–1.02]). Median OS with entrectinib was not reached, weighted median OS with crizotinib was 18.5 (15.1–19.9) months. Conclusion: Entrectinib administered in clinical trials may be associated with longer TTD than a real-world crizotinib population.