Updates on Novel Erythropoiesis-Stimulating Agents: Clinical and Molecular Approach

Moradi, Zahra; Maali, Amirhosein; Shad, Javad Sadeghi; Farasat, Alireza; Kouchaki, Reza; Moghadami, Mona; Ahmadi, Mohammad Hossein; Azad, Mehdi

doi:10.1007/s12288-019-01170-1

Cited by 11 publications

(6 citation statements)

References 81 publications

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“…All the treatment-related AEs were mild in severity and did not require any medication. General weakness and headache were the most commonly reported treatment-related AEs, which are already recognized to be common mild side effects of rHuEPO formulations [24]. Clinical laboratory results, ECG readings, vital signs, and physical tests all showed no clinically significant changes for receiving two doses (test and comparator) of EPO.…”

Section: Resultsmentioning

confidence: 99%

Biosimilarity of GBPD002 compared with Eprex^®through clinical evaluation in human

Nag¹,

Mohiuddin²,

Mahtab

et al. 2023

Preprint

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Background: The biosimilarity for erythropoietin (EPO) functionality of GBPD002 (test candidate) and Eprex(R) (comparator) has been evaluated by comparing the pharmacokinetic (PK) and pharmacodynamic (PD) properties following subcutaneous injection. Methods: This was a randomized, double-blinded, two-sequence, crossover clinical trial. Subjects were randomly assigned and received a dose (4,000 IU) of either the test or comparator EPO, and received the alternative formulations after 4-weeks of washout period. Results: The PK parameters, viz., maximum observed concentration (Cmax) and area under the curve extrapolated to infinity (AUC0-inf), were calculated with the serum EPO concentrations from blood samples and were found comparable for both formulations. The geometric mean ratios (at 90% CI) of the Cmax and AUCinf were 0.89 and 1.16, respectively, which were within the regulatory range of 0.80-1.25. The time-matched serum EPO concentrations and PD markers (reticulocyte, hematocrit, hemoglobin, and red blood cell) denoted a counterclockwise hysteresis, suggesting a time delay between the observed concentration and the response. ANOVA-derived P-values (>0.05) for the effectors clearly revealed the similarity between effects on PD markers for the test and comparator drugs. Both formulations were found tolerated well, and anti-drug antibodies were not observed. Conclusions: Thus, the two formulations are projected to be used interchangeably in clinical settings.

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Section: Resultsmentioning

confidence: 99%

Biosimilarity of GBPD002 compared with Eprex^®through clinical evaluation in human

Nag¹,

Mohiuddin²,

Mahtab

et al. 2023

Preprint

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“…Recently, the use of herbal products to treat in ammatory diseases has increased as a new method, and the herbs medications have played a vital role in health care (18). The focus of drug discovery efforts has shifted from the lab bench to nature, and herbal medicines are still a rich source for the development of new drugs (19,20). However, major barriers to the development of herbal medicines in the development of new drugs are the lack of scienti c evidence of functional mechanisms, unknown toxicity, and drug interactions (21).…”

Section: Discussionmentioning

confidence: 99%

Apigenin Acts as Anti-inflammatory Compound through Reducing IL-1β, IL-6 and TNF-α in LPS-induced Inflammation; in-vivo Study

Jamshidi

Sofiabadi

Eslami

et al. 2021

Preprint

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Background: Consumption of herbal flavonoids instead of chemical drugs has increased in recent years due to fewer side effects and affordability. In this study, the effect of apigenin was investigated on inflammation induced by lipopolysaccharide in male rat's serum by measuring the pro-inflammatory cytokines, i.e., IL-1β, IL-6, and TNF-α.Methods: 90 male Wistar rats weighing 200 ±2 grams were used and divided into control, sham (solvent), and positive control (dexamethasone 15 mg/kg. ip), and 3 experimental groups which received 5, 15 or 30 mg/kg of apigenin, intraperitoneally. In 30 minutes after interventions, lipopolysaccharide (LPS) [30 μg/kg. ip] was injected. Then, at 4, 12- and 24-hour intervals, rats were anesthetized, and blood samples were prepared intracardially. Samples were centrifuged, and serums were separated and stored at -80 ° C. Measurement of IL-1β, IL-6, and TNF-α were conducted by the enzyme-linked immunosorbent assay (ELISA) method. Data were analyzed using the SPSS software version 19.Results: Pre-injection of apigenin at 5 mg/kg dosage were reduced TNF-α and IL-1β levels at 24-hours after LPS injection, compared to control (for both P <0.05). Pre-injection of 15 mg/kg of apigenin was reduced IL-6 level at 24-hours after LPS injection (P <0.05). Pre-injection of 30 mg/kg of apigenin were reduced TNF-α level at 4- (P <0.05), 12- (P <0.01) and 24- (P <0.01) hours, IL-1β level at 24-hours (P <0.01), and IL-6 level at 4- (P <0.05) and 24- (P <0.01) hours after LPS injection.Conclusions: Apigenin reduces proinflammatory cytokines in serum in acute inflammation induction. This impact is close to the dexamethasone effect as an anti-inflammatory steroid drug.

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“…Erythropoietin (EPO) is a 30.4 kDa glycoprotein hormone expressed in the lungs, spleen, brain tissues, and liver, but the principal place of synthesis is represented by peritubular fibroblasts of the renal cortex [ 49 ].…”

Section: Managing Anemia In Cardiorenal Patientsmentioning

confidence: 99%

Managing Anemia: Point of Convergence for Heart Failure and Chronic Kidney Disease?

Buliga-Finis

Ouatu

Gosav

et al. 2023

Life

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The pathologic triangle formed by chronic heart failure (HF), chronic kidney disease (CKD), and anemia carries high morbidity and mortality rates and decreases quality of life. Anemia represents a common condition in patients with advanced HF and CKD, with a total prevalence in cardiorenal syndrome (CRS) ranging from 5% to 55%. Searching for a pragmatic approach for these patients with guided and disease-specific recommendations beyond just targeted hemoglobin therapeutic behavior represents the core of research for ongoing clinical trials. It is well known that the prevalence of anemia increases with the advancement of CKD and HF. The physiopathological mechanisms of anemia, such as the reduction of endogenous erythropoietin and the decrease in oxygen transport, are leading to tissue hypoxia, peripheral vasodilation, stimulating neurohormonal activity, and maintenance of the progressive renal and cardiac dysfunction. Given the challenges with the treatment options for patients with cardiorenal anemia syndrome (CRSA), new therapeutic agents such as hypoxia-inducible factor–prolyl hydroxylase domain inhibitors (HIF-PH) or hepcidin antagonists are emerging in the light of recent research. This review summarizes the potential therapeutic tools for anemia therapy in the cardiorenal population.

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Updates on Novel Erythropoiesis-Stimulating Agents: Clinical and Molecular Approach

Cited by 11 publications

References 81 publications

Biosimilarity of GBPD002 compared with Eprex^®through clinical evaluation in human

Biosimilarity of GBPD002 compared with Eprex^®through clinical evaluation in human

Apigenin Acts as Anti-inflammatory Compound through Reducing IL-1β, IL-6 and TNF-α in LPS-induced Inflammation; in-vivo Study

Managing Anemia: Point of Convergence for Heart Failure and Chronic Kidney Disease?

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Updates on Novel Erythropoiesis-Stimulating Agents: Clinical and Molecular Approach

Cited by 11 publications

References 81 publications

Biosimilarity of GBPD002 compared with Eprex®through clinical evaluation in human

Biosimilarity of GBPD002 compared with Eprex®through clinical evaluation in human

Apigenin Acts as Anti-inflammatory Compound through Reducing IL-1β, IL-6 and TNF-α in LPS-induced Inflammation; in-vivo Study

Managing Anemia: Point of Convergence for Heart Failure and Chronic Kidney Disease?

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Product

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Biosimilarity of GBPD002 compared with Eprex^®through clinical evaluation in human

Biosimilarity of GBPD002 compared with Eprex^®through clinical evaluation in human