Preclinical development of the antimicrobial peptide M33 and onset of regulatory procedures for clinical trials

2015 ◽  
Author(s):  
A Pini
Keyword(s):  
Clinical Trials ◽  
Antimicrobial Peptide ◽  
Preclinical Development

scholarly journals Bringing Advanced Therapies for Parkinson’s Disease to the Clinic: The Scientist’s Perspective

2021 ◽  
pp. 1-6
Author(s):  
Mark Tomishima ◽  
Agnete Kirkeby
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Phase I Clinical Trials ◽  
Preclinical Models ◽  
Preclinical Development ◽  
Dopaminergic Medication ◽  
Gene Therapies ◽  
Advanced Therapies ◽  
New Phase

After many years of preclinical development, cell and gene therapies have advanced from research tools in the lab to clinical-grade products for patients, and today they constitute more than a quarter of all new Phase I clinical trials for Parkinson’s disease. Whereas efficacy has been convincingly proven for many of these products in preclinical models, the field is now entering a new phase where the functionality and safety of these products will need to stand the test in clinical trials. If successful, these new products can have the potential to provide patients with a one-time administered treatment which may alleviate them from daily symptomatic dopaminergic medication.

scholarly journals The clinical advances of proteolysis targeting chimeras in oncology

2021 ◽  
Author(s):  
Hao Xie ◽  
Junjia Liu ◽  
Diego M. Alem Glison ◽  
Jason B. Fleming
Keyword(s):  
Clinical Trials ◽  
Small Molecules ◽  
Phase 1 ◽  
Hematologic Malignancies ◽  
Clinical Findings ◽  
Preclinical Development ◽  
Protein Targets ◽  
Initial Discovery ◽  
Clinical Advances ◽  
Initial Clinical Evaluation

Proteolysis targeting chimeras (PROTACs) are a class of small molecules designed to target proteins for degradation. Their novel and unique modes of action provide PROTACs with the potential for their application in the management of both solid and hematologic malignancies. Since its initial discovery, the technology of targeted protein degradation, especially in the form of PROTACs, has had significant advances. A number of PROTACs have entered a late stage of preclinical development. Several of them are either in phase 1/2 clinical trials or approaching approval for initial clinical evaluation. This article discusses the preclinical and clinical findings of PROTACs of clinically relevant protein targets in cancer.

Recent Advances in Clinical Trials of HCV Vaccines

2014 ◽  
Vol 3 (1) ◽  
pp. 10 ◽  
Author(s):  
Yongneng Luo ◽  
Limin Jiang ◽  
Zi'an Mao
Keyword(s):  
Clinical Trials ◽  
Viral Vectors ◽  
Vaccine Development ◽  
Viral Vector ◽  
Core Protein ◽  
Therapeutic Vaccine ◽  
Hcv Infection ◽  
Effective Vaccine ◽  
Protein Subunit ◽  
Preclinical Development

<p>  Hepatitis C virus infects nearly 3% of the global population, and spreads to 3-4 million new people annually. HCV infection is a leading cause of liver cirrhosis, hepatocellular carcinoma, and end-stage liver diseases and causes liver-related death in more than 300,000 people each year. Unfortunately, there is currently no vaccine for HCV prevention (prophylactic vaccine) or treatment (therapeutic vaccine). Circulating HCV is genetically diverse, and therefore a broadly effective vaccine must target conserved T- and B-cell epitopes of the virus and induce strong cross-reactive CD4+/CD8+ T-cell and neutralizing antibody responses in preventing or clearing HCV infection. So far, a few of vaccine development approaches are successful and some of the HCV vaccine candidates have reached human clinical trials, including those modalities mainly based on recombinant proteins (envelope proteins and core protein subunit), synthetic peptides, DNA (plasmid) and viral vectors (virosome). Encouraging results were obtained for those HCV vaccine formulations consisting of prime-boost regimen involving a live recombinant viral vector vaccine alone or in combination with DNA or subunit vaccine. Among several other vaccine strategies under preclinical development, the most promising one is virus like particle based vaccine that will be moving into human studies soon.</p>

scholarly journals Factors Important to the Prioritization and Development of Successful Topical Microbicides for HIV-1

2012 ◽  
Vol 2012 ◽  
pp. 1-12 ◽  
Author(s):  
Karen W. Buckheit ◽  
Robert W. Buckheit
Keyword(s):  
Clinical Trials ◽  
Ex Vivo ◽  
Sexual Transmission ◽  
Virus Transmission ◽  
Preclinical Development ◽  
Sexual Transmission Of Hiv ◽  
The Right ◽  
Hiv 1

Significant advancements in topical microbicide development have occurred since the prevention strategy was first described as a means to inhibit the sexual transmission of HIV-1. The lack of clinical efficacy of the first generation microbicide products has focused development attention on specific antiretroviral agents, and these agents have proven partially successful in human clinical trials. With greater understanding of vaginal and rectal virus infection, replication, and dissemination, better microbicide products and delivery strategies should result in products with enhanced potency. However, a variety of development gaps exist which relate to product dosing, formulation and delivery, and pharmacokinetics and pharmacodynamics which must be better understood in order to prioritize microbicide products for clinical development. In vitro, ex vivo, and in vivo models must be optimized with regard to these development gaps in order to put the right product at the right place, at the right time, and at the right concentration for effective inhibition of virus transmission. As the microbicide field continues to evolve, we must harness the knowledge gained from unsuccessful and successful clinical trials and development programs to continuously enhance our preclinical development algorithms.

scholarly journals Mesothelin-Targeted Agents in Clinical Trials and in Preclinical Development: Table 1.

2012 ◽  
Vol 11 (3) ◽  
pp. 517-525 ◽  
Author(s):  
Ronan J. Kelly ◽  
Elad Sharon ◽  
Ira Pastan ◽  
Raffit Hassan
Keyword(s):  
Clinical Trials ◽  
Targeted Agents ◽  
Preclinical Development

scholarly journals Update on Preclinical Development and Clinical Translation of Cholecystokinin-2 Receptor Targeting Radiopharmaceuticals

Cancers ◽  
2021 ◽  
Vol 13 (22) ◽  
pp. 5776
Author(s):  
Elisabeth von Guggenberg ◽  
Petra Kolenc ◽  
Christof Rottenburger ◽  
Renata Mikołajczak ◽  
Alicja Hubalewska-Dydejczyk
Keyword(s):  
Clinical Trials ◽  
Radionuclide Therapy ◽  
Medullary Thyroid Cancer ◽  
Clinical Results ◽  
Targeted Imaging ◽  
Clinical Use ◽  
Targeted Radionuclide Therapy ◽  
Imaging Studies ◽  
Preclinical Development ◽  
Medullary Thyroid

The cholecystokinin-2 receptor (CCK2R) has been a target of interest for molecular imaging and targeted radionuclide therapy for two decades. However, so far CCK2R targeted imaging and therapy has not been introduced in clinical practice. Within this review the recent radiopharmaceutical development of CCK2R targeting compounds and the ongoing clinical trials are presented. Currently, new gastrin derivatives as well as nonpeptidic substances are being developed to improve the properties for clinical use. A team of specialists from the field of radiopharmacy and nuclear medicine reviewed the available literature and summarized their own experiences in the development and clinical testing of CCK2R targeting radiopharmaceuticals. The recent clinical trials with novel radiolabeled minigastrin analogs demonstrate the potential for both applications, imaging as well as targeted radiotherapy, and reinforce the clinical applicability within a theranostic concept. The intense efforts in optimizing CCK2R targeting radiopharmaceuticals has led to new substances for clinical use, as shown in first imaging studies in patients with advanced medullary thyroid cancer. The first clinical results suggest that the wider clinical implication of CCK2R-targeted radiopharmaceuticals is reasonable.

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