scholarly journals Random-effects meta-analysis for systematic reviews of phase I clinical trials: Rare events and missing data

2016 ◽  
Vol 8 (2) ◽  
pp. 124-135 ◽  
Author(s):  
Mi-Ok Kim ◽  
Xia Wang ◽  
Chunyan Liu ◽  
Kathleen Dorris ◽  
Maryam Fouladi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Missing Data ◽  
Phase I ◽  
Random Effects ◽  
Systematic Reviews ◽  
Rare Events ◽  
Meta Analysis ◽  
Phase I Clinical Trials

Impact of precision medicine in refractory malignancies: A meta-analysis of 13,203 patients in phase I clinical trials.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 11520-11520 ◽  
Author(s):  
Maria Clemence Schwaederle ◽  
Melissa M. Zhao ◽  
J. Jack Lee ◽  
Vladimir Lazar ◽  
Brian Leyland-Jones ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Precision Medicine ◽  
Meta Analysis ◽  
Phase I Clinical Trials

scholarly journals Self-Replicating RNA Viruses for RNA Therapeutics

Molecules ◽  
2018 ◽  
Vol 23 (12) ◽  
pp. 3310 ◽  
Author(s):  
Kenneth Lundstrom
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Tumor Cells ◽  
Neutralizing Antibodies ◽  
Ebola Virus ◽  
Vaccine Development ◽  
Rna Viruses ◽  
Antibody Responses ◽  
Phase Iii ◽  
Phase I Clinical Trials

Self-replicating single-stranded RNA viruses such as alphaviruses, flaviviruses, measles viruses, and rhabdoviruses provide efficient delivery and high-level expression of therapeutic genes due to their high capacity of RNA replication. This has contributed to novel approaches for therapeutic applications including vaccine development and gene therapy-based immunotherapy. Numerous studies in animal tumor models have demonstrated that self-replicating RNA viral vectors can generate antibody responses against infectious agents and tumor cells. Moreover, protection against challenges with pathogenic Ebola virus was obtained in primates immunized with alphaviruses and flaviviruses. Similarly, vaccinated animals have been demonstrated to withstand challenges with lethal doses of tumor cells. Furthermore, clinical trials have been conducted for several indications with self-amplifying RNA viruses. In this context, alphaviruses have been subjected to phase I clinical trials for a cytomegalovirus vaccine generating neutralizing antibodies in healthy volunteers, and for antigen delivery to dendritic cells providing clinically relevant antibody responses in cancer patients, respectively. Likewise, rhabdovirus particles have been subjected to phase I/II clinical trials showing good safety and immunogenicity against Ebola virus. Rhabdoviruses have generated promising results in phase III trials against Ebola virus. The purpose of this review is to summarize the achievements of using self-replicating RNA viruses for RNA therapy based on preclinical animal studies and clinical trials in humans.

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