更新于：2024-11-04
Frontage Laboratories, Inc.
更新于：2024-11-04
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A Multicenter, Open-label, Phase 2, Basket Study to Evaluate the Efficacy and Safety of SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
一项在接受VEGFR抑制剂后导致手足皮肤反应的癌症患者中评价OQL011安全性和有效性的II期研究
一项在心力衰竭和射血分数降低患者中评价 INL1（Trientine）效果的随机化、双盲、安慰剂对照研究
100 项与 Frontage Laboratories, Inc. 相关的临床结果
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2024-07-01Current Analytical Chemistry
A Novel Electrochemiluminescence (ECL) Immunoassay for the Quantitation
of Monoclonal Antibody (mAb) PYX-106 in Human Serum
作者: Wang, Jianxin ; Balogh, Gabriela A. ; Simon, Teri ; Squicciarini, Mariana ; Yin, Feng ; Pinkas, Jan ; Adhikari, Diana ; Yang, Wensheng ; Harriman, Shawn ; Liu, Xiaodong F. ; Dyszel, Mike ; Ke, Yan ; Bruce, Lisa ; Lei, Wenji
Background:::
PYX-106 is a novel monoclonal antibody (mAb), targeting the sialic acidbinding
immunoglobulin-like lectin 15 (Siglec-15) in the Tumor Microenvironment (TME). Precise
measurement of PYX-106 is essential for the thorough assessment of PYX-106 pharmacokinetics
in clinical investigations.
Methods:::
A novel Electrochemiluminescence (ECL) immunoassay for the quantitation of PYX-
106 in human serum was developed and validated. Biotinylated anti-PYX-106 antibody Bio-A1A1
was employed as the capture antibody, and ruthenylated anti-PYX-106 antibody Ru-A3G10 was
utilized as the detection antibody in the ECL immunoassay on Meso Scale Discovery (MSD) platform.
Results:::
This assay was fully validated in terms of selectivity, accuracy, precision, hook effect,
stability, etc., with a dynamic range from 50.0 to 2,500 ng/mL in human serum under the 2018
U.S. Food and Drug Administration (FDA) guidance and the 2022 U.S. FDA ICH M10 guidance.
Conclusion:::
PYX-106 bioanalytical assay validation was reported for the first time in a biological
matrix, and this assay has been successfully applied to support a clinical trial PYX-106-101.
2024-06-01TOXICOLOGY AND APPLIED PHARMACOLOGY
Effects of pethoxamid treatment on the disposition of thyroxine in rats
Article
作者: Bentley, Karin ; Nallani, Gopinath ; McClanahan, Robert ; Chandrasekaran, Appavu
Pethoxamid (PXA) is a chloroacetamide herbicide that works by inhibiting the germination of target weeds in crops. PXA is not a genotoxic agent, however, in a two-year chronic toxicity study, incidence of thyroid follicular cell hyperplasia was observed in male rats treated at a high dose. Many non-mutagenic chemicals, including agrochemicals are known to produce thyroid hyperplasia in rodents through a hepatic metabolizing enzyme induction mode of action (MoA). In this study, the effects of oral gavage PXA treatment at 300 mg/kg for 7 days on the disposition of intravenously (iv) administered radio-labeled thyroxine ([125I]-T4) was assessed in bile-duct cannulated (BDC) rats. Another group of animals were treated with phenobarbital (PB, 100 mg/kg), a known enzyme inducer, serving as a positive control. The results showed significant increase (p < 0.01) in the mean liver weights in the PB and PXA-treated groups relative to the control group. The serum total T4 radioactivity Cmax and AUC0-4 values for PB and PXA-treated groups were lower than for the control group, suggesting increased clearance from serum. The mean percentages of administered radioactivity excreted in bile were 7.96 ± 0.38%, 16.13 ± 5.46%, and 11.99 ± 2.80% for the control, PB and PXA groups, respectively, indicating increased clearance via the bile in the treated animals. These data indicate that PXA can perturb the thyroid hormone homeostasis in rats by increasing T4 elimination in bile, possibly through enzyme induction mechanism similar to PB. In contrast to humans, the lack of high affinity thyroid binding globulin (TBG) in rats perhaps results in enhanced metabolism of T4 by uridine diphosphate glucuronosyl transferase (UGT). Since this liver enzyme induction MoA for thyroid hyperplasia by PB is known to be rodent specific, PXA effects on thyroid can also be considered not relevant to humans. The data from this study also suggest that incorporating a BDC rat model to determine thyroid hormone disposition using [125I]-T4 is valuable in a thyroid mode of action analysis.
2024-04-01The Journal of nutrition
Comparison of a Daily Steviol Glycoside Beverage compared with a Sucrose Beverage for Four Weeks on Gut Microbiome in Healthy Adults
Article
作者: Lam, Caanan ; Chakrabarti, Anirikh ; Kwok, David ; Hutton, Thomas ; Scott, Corey ; Au-Yeung, Fei ; Strom, Noah ; Wolever, Thomas Ms
BACKGROUND:
Recent studies suggest that some nonnutritive sweeteners (NNS) have deleterious effects on the human gut microbiome (HGM). The effect of steviol glycosides on the HGM has not been well studied.
OBJECTIVE:
We aimed to evaluate the effects of stevia- compared with sucrose-sweetened beverages on the HGM and fecal short-chain fatty acid (SCFA) profiles.
METHODS:
Using a randomized, double-blinded, parallel-design study, n = 59 healthy adults [female/male, n = 36/23, aged 31±9 y, body mass index (BMI): 22.6±1.7 kg/m2] consumed 16 oz of a beverage containing either 25% of the acceptable daily intake (ADI) of stevia or 30 g of sucrose daily for 4 weeks followed by a 4-week washout. At weeks 0 (baseline), 4, and 8, the HGM was characterized via shotgun sequencing, fecal SCFA concentrations were measured using ultra-high performance liquid chromatography-tandem mass spectrometry and anthropometric measurements, fasting serum glucose, insulin and lipids, blood pressure, pulse, and 3-d diet records were obtained.
RESULTS:
There were no significant differences in the HGM or fecal SCFA between the stevia and sucrose groups at baseline (P > 0.05). At week 4 (after intervention), there were no significant differences in the HGM at the phylum, family, genus, or species level between the stevia and sucrose groups and no significant differences in fecal SCFA. At week 4, BMI had increased by 0.3 kg/m2 (P = 0.013) in sucrose compared with stevia, but all other anthropometric and cardiometabolic measures and food intake did not differ significantly (P > 0.05). At week 8 (after washout), there were no significant differences in the HGM, fecal SFCA, or any anthropometric or cardiometabolic measure between the stevia and sucrose groups (P > 0.05).
CONCLUSIONS:
Daily consumption of a beverage sweetened with 25% of the ADI of stevia for 4 weeks had no significant effects on the HGM, fecal SCFA, or fasting cardiometabolic measures, compared with daily consumption of a beverage sweetened with 30 g of sucrose.
TRIAL REGISTRATION:
clinicaltrials.gov as NCT05264636.
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