A randomized, double-blind, placebo-controlled investigation of BCc1 nanomedicine effect on survival and quality of life in metastatic and non-metastatic gastric cancer patients

Background: Currently, the main goal of cancer research is to increase longevity of patients suffering malignant cancers. The promising results of BCc1 in vitro and vivo experiments made us look into the effect of BCc1 nanomedicine on patients with cancer in a clinical trial. Methods: The present investigation was a randomized, double-blind, placebo-controlled, parallel, and multicenter study in which 123 patients (30-to-85-year-old men and women) with metastatic and non-metastatic gastric cancer, in two separate groups of BCc1 nanomedicine or placebo, were selected using a permuted block randomization method. For metastatic and non-metastatic patients, a daily dose of 3000 and 1500 mg was prescribed, respectively. Overall survival (OS) as the primary endpoint and quality of life (measured using QLQ-STO22) and adverse effects as the secondary endpoints were studied. Results: In metastatic patients, the median OS was significantly higher in BCc1 nanomedicine (174 days 95% confidence interval (CI) 82.37-265.62) than in placebo (62 days 95% CI 0-153.42); hazard ratio (HR): 0.5 95% CI 0.25-0.98; p = 0.046. In non-metastatic patients, the median OS was significantly higher in BCc1 nanomedicine (529 days 95% CI 393.245-664.75) than in placebo (345 days 95% CI 134.85-555.14); HR: 0.324 95% CI 0.97-1.07; p = 0.066. The QLQ-STO22 assessment showed a mean difference improvement of 3.25 and 2.29 (p value > 0.05) in BCc1 nanomedicine and a mean difference deterioration of - 4.42 and - 3 (p-value < 0.05) in placebo with metastatic and non-metastatic patients, respectively. No adverse effects were observed. Conclusion: The findings of this trial has provided evidence for the potential capacity of BCc1 nanomedicine for treatment of cancer. Trial registration IRCTID, IRCT2017101935423N1. Registered on 19 October 2017, http://www.irct.ir/ IRCT2017101935423N1 © 2019 The Author(s)

Growth performance, nutrient digestibility, bone mineralization, gut morphology, and antioxidant status in meat-type turkeys receiving diets supplemented with advanced chelate compounds-based minerals

SUMMARY: The aim of this study was to examine the efficiency of dietary supplementation with advanced chelate compounds-based trace minerals (CTM) in growing turkeys. A total of 336 one-day-old turkeys were assigned to 3 dietary treatments, consisting of 8 replicates of 14 birds each. Experimental treatments included: ITM (basal diet; commercially recommended levels of inorganic TM), CTM50 (CTM replaced at 50% of ITM), and CTM100 (CTM replaced at 100% of ITM). After 112 d, body weight, average daily gain, and feed conversion ratio in turkeys fed with the ITM were also similar to those of the turkeys in the CTM50 group, but poorer (P < 0.05) than those for the CTM100 group. When compared to the ITM diet, the CTM100 diet increased ileal digestibility coefficients of crude fat, energy, ash, and phosphorus; tibia length; tibia ash, phosphorus, zinc, manganese, and copper contents; jejunal villus height, villus height/crypt depth ratio, and villus surface area; and serum total antioxidant capacity, superoxide dismutase, and catalase values (P < 0.05). The CTM50 diet also increased ileal digestibility coefficients of crude ash and phosphorus, as well as tibia ash and phosphorus contents (P < 0.05) compared to the ITM diet. These findings indicate that, while CTM supplementation at 50% of the commercially recommended levels could support growth performance, a complete replacement of ITM with equivalent levels of CTM could beneficially influence growth performance, bone mineralization, gut morphology, and antioxidant status in growing turkeys

TLc-A, the leading nanochelating-based nanochelator, reduces iron overload in vitro and in vivo

Iron chelation therapy is an effective approach to the treatment of iron overload conditions, in which iron builds up to toxic levels in the body and may cause organ damage. Treatments using deferoxamine, deferasirox and deferiprone have been introduced and despite their disadvantages, they remain the first-line therapeutics in iron chelation therapy. Our study aimed to compare the effectiveness of the iron chelation agent TLc-A, a nano chelator synthetized based on the novel nanochelating technology, with deferoxamine. We found that TLc-A reduced iron overload in Caco2 cell line more efficiently than deferoxamine. In rats with iron overload, very low concentrations of TLc-A lowered serum iron level after only three injections of the nanochelator, while deferoxamine was unable to reduce iron level after the same number of injections. Compared with deferoxamine, TLc-A significantly increased urinary iron excretion and reduced hepatic iron content. The toxicity study showed that the intraperitoneal median lethal dose for TLc-A was at least two times higher than that for deferoxamine. In conclusion, our in vitro and in vivo studies indicate that the novel nano chelator compound, TLc-A, offers superior performance in iron reduction than the commercially available and widely used deferoxamine. © 2016, The Japanese Society of Hematology