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What's next in the pipeline.

Publication ,  Journal Article
Vincenti, F; Kirk, AD
Published in: Am J Transplant
October 2008

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.

Duke Scholars

Published In

Am J Transplant

DOI

EISSN

1600-6143

Publication Date

October 2008

Volume

8

Issue

10

Start / End Page

1972 / 1981

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Surgery
  • Reperfusion Injury
  • Organ Transplantation
  • Models, Biological
  • Immunosuppressive Agents
  • Immunosuppression Therapy
  • Humans
  • Drug Industry
 

Citation

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Chicago
ICMJE
MLA
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Vincenti, F., & Kirk, A. D. (2008). What's next in the pipeline. Am J Transplant, 8(10), 1972–1981. https://doi.org/10.1111/j.1600-6143.2008.02403.x
Vincenti, F., and A. D. Kirk. “What's next in the pipeline.Am J Transplant 8, no. 10 (October 2008): 1972–81. https://doi.org/10.1111/j.1600-6143.2008.02403.x.
Vincenti F, Kirk AD. What's next in the pipeline. Am J Transplant. 2008 Oct;8(10):1972–81.
Vincenti, F., and A. D. Kirk. “What's next in the pipeline.Am J Transplant, vol. 8, no. 10, Oct. 2008, pp. 1972–81. Pubmed, doi:10.1111/j.1600-6143.2008.02403.x.
Vincenti F, Kirk AD. What's next in the pipeline. Am J Transplant. 2008 Oct;8(10):1972–1981.
Journal cover image

Published In

Am J Transplant

DOI

EISSN

1600-6143

Publication Date

October 2008

Volume

8

Issue

10

Start / End Page

1972 / 1981

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Surgery
  • Reperfusion Injury
  • Organ Transplantation
  • Models, Biological
  • Immunosuppressive Agents
  • Immunosuppression Therapy
  • Humans
  • Drug Industry