Document Detail


What's next in the pipeline.
MedLine Citation:
PMID:  18828764     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The first decade of the new millennium has been disappointing for transplant therapeutics: no new immunosuppression agents have been approved. Several high profile drugs and biologics failed the rigors of clinical trials or had disappointing preclinical results (FTY720, FK778, anti-CDI54, anti-IL15, anti-CD28, R3421). Several challenges face the industry and clinical investigators in bringing novel drugs to the clinic including the difficulty in targeting new endpoints for toxicities or chronic allograft disease since acute rejection has been reduced to below 15% as well as the Food and Drug Administration insistence of excluding the use of immunosuppression regimens embraced by the transplant community in control arms of clinical trials. Currently six new agents, 3 small molecules (ISA247, a semisynthetic analogue of cyclosporine; AEB071, a protein kinase C isoforms inhibitor; CP 690,550, a selective Janus kinase inhibitor) are in phase II trials and 3 biologics (belatacept, a second generation CTLA4Ig; efalizumab, a humanized antiCD11a [LFA1] monoclonal antibody; and alefacept, a LFA3-IgG1 fusion receptor protein) are in phase II/III clinical trials. The preclinical pipeline is not only full but promises to address previously neglected targets and fulfill unmet medical needs in transplant therapeutics.
Authors:
F Vincenti; A D Kirk
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons     Volume:  8     ISSN:  1600-6143     ISO Abbreviation:  Am. J. Transplant.     Publication Date:  2008 Oct 
Date Detail:
Created Date:  2008-10-02     Completed Date:  2009-03-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100968638     Medline TA:  Am J Transplant     Country:  Denmark    
Other Details:
Languages:  eng     Pagination:  1972-81     Citation Subset:  IM    
Affiliation:
University of California, San Francisco, Kidney Transplant Service, San Francisco, CA, USA. Flavio.Vincenti@ucsfmedctr.org
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MeSH Terms
Descriptor/Qualifier:
B-Lymphocytes / drug effects
Biological Products / pharmacology
Cell Adhesion
Clinical Trials as Topic
Cytokines / metabolism
Drug Design
Drug Industry / trends*
Humans
Immunosuppression / methods*
Immunosuppressive Agents / chemistry,  pharmacology*
Models, Biological
Organ Transplantation / methods,  trends
Reperfusion Injury
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Biological Products; 0/Cytokines; 0/Immunosuppressive Agents

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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