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Workshop Proceedings: Streamlined Development of Safety Assessment Programs Supporting Orphan/Rare Diseases--Are We There Yet?
A workshop entitled "Streamlined Development of Safety Assessment Programs Supporting Orphan/Rare Diseases—Are We There Yet?" was held at the 36th Annual Meeting of the American College of Toxicology in Summerlin, Nevada. The workshop was sponsored by Shire and Ultragenyx and was designed to present the nonclinical considerations for the development of various products for rare diseases. A panel of experts from industry and government highlighted the nonclinical considerations in developing toxicology programs supporting rare disease therapeutics, challenges in preclinical safety assessment, reviewed the current guid...
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Allamneni, K. P., Parker, S., ONeill, C. A., Wright, T. L., King, S., Andrews, L. Tags: ACT Annual Meeting Session Overview Articles Source Type: research

Symposium Summary: "Breathe In, Breathe Out, Its Easy: What You Need to Know About Developing Inhaled Drugs"
Developing inhaled drugs requires knowledge of lung anatomy, cell biology, respiratory physiology, particle physics, and some plumbing. Although dose makes the poison, in the context of an inhaled drug, the "dose" is not easily defined. This lack of clarity around dose poses issues and challenges in the design of inhalation toxicology programs. To better understand dose, the influence of ventilation is discussed as are the perturbations in pulmonary function observed with inhalation exposure that can affect dose. Methods for determining inhaled drug deposition to arrive at an estimate of lung dose are examined. Equally imp...
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Tepper, J. S., Kuehl, P. J., Cracknell, S., Nikula, K. J., Pei, L., Blanchard, J. D. Tags: ACT Annual Meeting Session Overview Articles Source Type: research

Editors Note
(Source: International Journal of Toxicology)
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Genter, M. B. Tags: Editorial Source Type: research

Book Review: Arsenic Toxicity--Prevention and Treatment
(Source: International Journal of Toxicology)
Source: International Journal of Toxicology - May 9, 2016 Category: Toxicology Authors: Kapp, R. W. Tags: Book Review Source Type: research

A Risk-Based Strategy for Evaluating Mitigation Options for Process-Formed Compounds in Food: Workshop Proceedings
Processing (eg, cooking, grinding, drying) has changed the composition of food throughout the course of human history; however, awareness of process-formed compounds, and the potential need to mitigate exposure to those compounds, is a relatively recent phenomenon. In May 2015, the North American Branch of the International Life Sciences Institute (ILSI North America) Technical Committee on Food and Chemical Safety held a workshop on the risk-based process for mitigation of process-formed compounds. This workshop aimed to gain alignment from academia, government, and industry on a risk-based process for proactively assessi...
Source: International Journal of Toxicology - May 9, 2016 Category: Toxicology Authors: Hanlon, P., Brorby, G. P., Krishan, M. Tags: ILSI Symposium Overview Source Type: research

Efficacy of Recommended Prehospital Human Equivalent Doses of Atropine and Pralidoxime Against the Toxic Effects of Carbamate Poisoning in the Hartley Guinea Pig
Conclusion: The results suggest that coadministration of atropine and 2-PAM Cl at the currently recommended human equivalent doses for use in the prehospital setting to treat organophosphorus nerve agent and pesticide poisoning would likely also be effective against aldicarb or methomyl poisoning. (Source: International Journal of Toxicology)
Source: International Journal of Toxicology - May 9, 2016 Category: Toxicology Authors: Brittain, M. K., McGarry, K. G., Moyer, R. A., Babin, M. C., Jett, D. A., Platoff, G. E., Yeung, D. T. Tags: Regular Articles Source Type: research

Repression of Biotin-Related Proteins by Benzo[a]Pyrene-Induced Epigenetic Modifications in Human Bronchial Epithelial Cells
Benzo[a]pyrene (B[a]P) exposure has been associated with the alteration in epigenetic marks that are involved in cancer development. Biotinidase (BTD) and holocarboxylase synthetase (HCS) are 2 major enzymes involved in maintaining the homeostasis of biotinylation, and the deregulation of this pathway has been associated with a number of cancers. However, the link between B[a]P exposure and the dysregulation of BTD/HCS in B[a]P-associated tumorigenesis is unknown. Here we showed that the expression of both BTD and HCS was significantly decreased upon B[a]P treatment in human bronchial epithelial (16HBE) cells. Benzo[a]pyre...
Source: International Journal of Toxicology - May 9, 2016 Category: Toxicology Authors: Xia, B., Yang, L.-Q., Huang, H.-Y., Pang, L., Yang, X.-F., Yi, Y.-J., Ren, X.-H., Li, J., Zhuang, Z.-X., Liu, J.-J. Tags: Regular Articles Source Type: research

Genetic Instability in Lymphocytes is Associated With Blood Plasma Antioxidant Levels in Health Care Workers Occupationally Exposed to Ionizing Radiation
This study shows that the susceptibility of peripheral blood lymphocytes to chromosomal damage is associated with plasma antioxidant levels. Furthermore, increased levels of blood plasma GSH, TAC, and SOD in occupationally exposed individuals could be an adaptive measure in response to oxidative stress to protect somatic cell genetic integrity. (Source: International Journal of Toxicology)
Source: International Journal of Toxicology - May 9, 2016 Category: Toxicology Authors: Kumar, D., Kumari, S., Salian, S. R., Uppangala, S., Kalthur, G., Challapalli, S., Chandraguthi, S. G., Kumar, P., Adiga, S. K. Tags: Regular Articles Source Type: research

JAK2/STAT3 Pathway Mediates Protection of Metallothionein Against Doxorubicin-Induced Cytotoxicity in Mouse Cardiomyocytes
Doxorubicin (Dox) is one of the most important anticancer agents; however, its clinical application is limited by its severe cardiotoxicity. In our previous study, we found that the gene expression levels of the Janus-activated kinase/signal transducer and activator of transcription 3 (JAK2/STAT3) pathway were different between MT–/– cardiomyocytes and MT+/+ cardiomyocytes when they were treated with Dox. Thus, this study was intended to investigate the role of JAK2/STAT3 pathway in metallothionein (MT) protection of Dox-induced cardiotoxicity. Tyrphostin AG490 (α-cyano-(3,4-dihydroxy)-N-benzylcinnamide) ...
Source: International Journal of Toxicology - May 9, 2016 Category: Toxicology Authors: Rong, J., Li, L., Jing, L., Fang, H., Peng, S. Tags: Regular Articles Source Type: research

Nonclinical Safety Assessment of SYN-004: An Oral {beta}-lactamase for the Protection of the Gut Microbiome From Disruption by Biliary-Excreted, Intravenously Administered Antibiotics
SYN-004 is a first in class, recombinant β-lactamase that degrades β-lactam antibiotics and has been formulated to be administered orally to patients receiving intravenous β-lactam antibiotics including cephalosporins. SYN-004 is intended to degrade unmetabolized antibiotics excreted into the intestines and thus has the potential to protect the gut microbiome from disruption by these antibiotics. Protection of the gut microbiome is expected to protect against opportunistic enteric infections such as Clostridium difficile infection as well as antibiotic-associated diarrhea. In order to demonstrate that oral S...
Source: International Journal of Toxicology - May 9, 2016 Category: Toxicology Authors: Kokai-Kun, J. F., Bristol, J. A., Setser, J., Schlosser, M. Tags: Regular Articles Source Type: research

Nonclinical Safety Profile of Etelcalcetide, a Novel Peptide Calcimimetic for the Treatment of Secondary Hyperparathyroidism
Etelcalcetide is a novel d-amino acid peptide that functions as an allosteric activator of the calcium-sensing receptor and is being developed as an intravenous calcimimetic for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. To support clinical development and marketing authorization, a comprehensive nonclinical safety package was generated. Primary adverse effects included hypocalcemia, tremoring, and convulsions. Other adverse effects were considered sequelae of stress associated with hypocalcemia. Cardiovascular safety evaluations in the dog revealed an anticipate...
Source: International Journal of Toxicology - May 9, 2016 Category: Toxicology Authors: Fielden, M. R., Dean, C., Black, K., Sawant, S. G., Subramanian, R., Tomlinson, J. E., Walter, S., Zimmermann, C., Griggs, M. W., McKeon, M. E., Lewis, E. M., Beevers, C., Pyrah, I. Tags: Regular Articles Source Type: research

2-Deoxy-D-Glucose (2-DG)-Induced Cardiac Toxicity in Rat: NT-proBNP and BNP as Potential Early Cardiac Safety Biomarkers
In conclusion, NT-proBNP and BNP are potential early biomarkers for 2-DG-induced cardiac toxicity that can be useful to monitor 2-DG therapy in clinical trials. (Source: International Journal of Toxicology)
Source: International Journal of Toxicology - May 9, 2016 Category: Toxicology Authors: Terse, P. S., Joshi, P. S., Bordelon, N. R., Brys, A. M., Patton, K. M., Arndt, T. P., Sutula, T. P. Tags: Regular Articles Source Type: research

Prenatal Exposure to Soy Isoflavones Altered the Immunological Parameters in Female Rats
Information on the effects of phytoestrogens on animals has increased recently; however, there were only few studies on prenatal exposure on cellular immune response. Pregnant rats were assigned to 3 groups (12 rats per group), the first was fed control diet, the second was fed low-dose (6.5 g/100 g of diet) soy isoflavones, while the third was fed high-dose (26 g/100 g of diet) soy isoflavones. The female offspring cell-mediated immune response was determined using phytohemagglutinin (PHA) injection, and intumesce index was calculated on postnatal day 50. After 24 hours of PHA injection, blood samples were collected for t...
Source: International Journal of Toxicology - May 9, 2016 Category: Toxicology Authors: Ebaid, H. M., Elgawish, R. A. R., Abdelrazek, H. M. A., Gaffer, G., Tag, H. M. Tags: Regular Articles Source Type: research

Perspective on a Modified Developmental and Reproductive Toxicity Testing Strategy for Cancer Immunotherapy
The intent of cancer immunotherapy (CIT) is to generate and enhance T-cell responses against tumors. The tumor microenvironment establishes several inhibitory pathways that lead to suppression of the local immune response, which is permissive for tumor growth. The efficacy of different CITs, alone and in combination, stems from reinvigorating the tumor immune response via several mechanisms, including costimulatory agonists, checkpoint inhibitors, and vaccines. However, immune responses to other antigens (self and foreign) may also be enhanced, resulting in potentially undesired effects. In outbred mammalian pregnancies, t...
Source: International Journal of Toxicology - May 9, 2016 Category: Toxicology Authors: Prell, R. A., Halpern, W. G., Rao, G. K. Tags: Regular Articles Source Type: research

Thanks to Reviewers
(Source: International Journal of Toxicology)
Source: International Journal of Toxicology - March 17, 2016 Category: Toxicology Tags: Information for Authors Source Type: research