Evidence map›Paper›PMID 20166241›Full record

ArticleAnti-cancer drugs2010

Safety evaluation and pharmacokinetics of a novel human tumor necrosis factor-alpha exhibited a higher antitumor activity and a lower systemic toxicity.

Meng Li, Xin Qin, Xiaochang Xue, Cun Zhang, Zhen Yan, Wei Han, Chris Komarck, Thomas D Wang, Yingqi Zhang

Open access · greenAbstract read
In one paragraph

Article in Anti-cancer drugs, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 3 countries.

Meng LiBiotechnology Center, Department of Pharmacy, State Key Laboratory of Cancer Biology, Fourth Military Medical University, Xi'an, Shaanxi, People's Republic of China.
Xin Qin
Xiaochang Xue
Cun Zhang
Zhen Yan
Wei Han
Chris Komarck
Thomas D Wang
Yingqi Zhang
Air Force Medical University · CNBiotechnology Research Center · IRUniversity of Michigan–Ann Arbor · US

Funding

Task Specific Project 4U54CA136429 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI REHEMTULLA, ALNAWAZ · 2008 to 2012
$5.2M
NCI NIH HHS U54 CA136429
6 · The paper itself

Abstract

We had prepared earlier a prokaryotic-expressed tumor necrosis factor-alpha (TNF-[alpha]) mutant that exhibited a higher antitumor activity and a lower systemic toxicity compared with that of wild-type TNF-[alpha] in both syngeneic murine tumor models and human tumor xenografts models. For its clinical use as an antitumor agent, we evaluated repeated-dose toxicity, anaphylaxis, genetic toxicity, pharmacokinetic, and metabolism in different animals according to the criteria of the biological investigational new drug application. It was found to be safe at a dose of 4x10(6) IU/kg/day for 60 days after administration in rhesus monkeys, but the TNF-[alpha] antibody level and liver toxicity needed to be monitored. No systemic anaphylaxis or genetic toxicity was found and the pharmacokinetic characteristics of the recombinant mutated human TNF-[alpha] (rmhTNF-[alpha]) were suited for clinical use. More than 96.3% of rmhTNF-[alpha] could be reclaimed from the urine and feces in 24 h after administration, which indicated the main excretion route. The results proved that the characteristics of this rmhTNF-[alpha] satisfied clinical trial requirements. The related positive clinical trial results will be reported in future. This study of novel rmhTNF-[alpha] is of considerable importance, not only given the proven usefulness of TNF-[alpha] local application therapies under isolated limp perfusion and isolated hepatic perfusion conditions for selected indications, but also implicated for systemic application of TNF-[alpha].

Indexed as

AnimalsAntineoplastic AgentsFemaleGuinea PigsHumansMacaca mulattaMaleMiceRabbitsRatsRecombinant ProteinsTumor Necrosis Factor-alphaXenograft Model Antitumor AssaysAntineoplastic AgentsRecombinant ProteinsTumor Necrosis Factor-alpha

Identifiers

PMID20166241
PMCPMC4266396
OpenAlexW1980405585

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.