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Oprelvekin. Genetics Institute.

S V Sitaraman1, A T Gewirtz

  • 1Emory University School of Medicine, Department of Pathology and Laboratory Medicine, Atlanta, GA 30322, USA. ssitar2@emory.edu

Current Opinion in Investigational Drugs (London, England : 2000)
|March 14, 2002
PubMed
Summary

Oprelvekin, a recombinant human interleukin-11, is approved for preventing thrombocytopenia in cancer patients. Clinical trials are ongoing for Crohn's disease, colitis, rheumatoid arthritis, and psoriasis.

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Area of Science:

  • Biotechnology
  • Pharmacology
  • Oncology

Background:

  • Oprelvekin (rhIL-11; Neumega) is a recombinant form of human interleukin-11 developed by Genetics Institute.
  • It received FDA clearance in November 1997 for preventing severe thrombocytopenia and reducing platelet transfusions in chemotherapy patients with non-myeloid malignancies.

Purpose of the Study:

  • To evaluate the efficacy and safety of oprelvekin in various therapeutic areas.
  • To explore new indications for oprelvekin beyond its initial approval.

Main Methods:

  • Phase III trials for Crohn's disease were underway by December 1999.
  • Phase II trials for mild-to-moderate Crohn's disease and mucositis were initiated.
  • Phase I/II clinical trials were conducted for colitis, rheumatoid arthritis, and psoriasis.

Main Results:

  • Oprelvekin was launched in late 1997 for its approved indication.
  • An oral formulation for Crohn's disease was developed.
  • Marketing rights are distributed globally, with ongoing development and trials in North America, Europe, Asia, and Japan.

Conclusions:

  • Oprelvekin has demonstrated utility in managing chemotherapy-induced thrombocytopenia.
  • Ongoing clinical trials suggest potential therapeutic applications in inflammatory and autoimmune diseases.
  • The drug's development involves multiple pharmaceutical partners and extensive clinical trial programs worldwide.

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