Clinical Research

Clinical Research on Adverse Reactions to Nevirapine and Gene Polymorphisms

Nevirapine (NVP)
  • Anti-HIV agent developed by Boehringer-Ingelheim and marketed under the trade name Viramune
  • Widely used in developing countries as a result of more relaxed intellectual property rights
  • Among Thai patients, 11 to 40% develop skin rashes, and a portion of these become severe, which is a problem
  • Collaborative research between RIKEN and Mahidol University in Thailand suggests a link between adverse reactions caused by nevirapine and HLA-B*3505.
    (S. Chantarangsu, T. Mushiroda, et. al., Pharmacogenetics & Genomics: Feb 2009, Vol. 19, Issue 2, pp 139-146.)
Overview of the clinical research
  • Project period: April 2009 through September 2010 (18 months)
  • arget patient: 2,200 AIDS patients
  • Verification method: Nevirapine will be administered to 1,100 of the patients. The remaining 1,100 patients will undergo genotype analysis, and those determined to be at risk of drug rash will be switched to a different drug. Onset frequency will be compared between the two groups in order to verify the effectiveness of Nevirapine.

Clinical Research on Warfarin Dosage and SNP

  • Only one oral anticoagulant medicine
    Treatment and prevention of thrombotic disorders (e.g., cerebral infarction, pulmonary embolism)
  • Drug efficiency varies widely between individuals and dosage control is difficult
    Overdosage→ Bleeding (e.g., cerebral haemorrhage, subcutaneous haemorrhage)
    Underdosage → Thrombogenesis
  • Drug efficiency depends on SNP such as CYP2C9 and VKORC1
    SNP typing can indicate best dosage
Results of clinical research (Joint research with RIKEN and Hayama HEART CENTER)
  • Genotyping of 4 SNPs associated with Warfarin efficiency
  • Study of 200 patients taking Warfarin
  • No false data was confirmed
  • Results consisting with other research reports

Somatic mutation detection technology

Acquired gene mutations, such as those seen in cancer, are referred to as somatic mutations. In recent years, a variety of anticancer agents have been developed that attack specific molecules in cancer cells. These agents are called molecularly-targeted agents. When a mutation occurs in the target molecule, however, the effect of these drugs may be lost, or conversely, in some cases heightened. Since tissue removed from cancer patients includes many healthy cells, highly sensitive detection technology is required to detect these gene mutations. With our system, a crushed tissue sample is simply placed into the DNA purification cartridge. The analyzer then performs a fully automated gene mutation analysis.

Gene mutations and anticancer agents
  • BCR-ABL fusion gene and Glivec, a drug used to treat chronic myelogenous leukemia
  • EGFR mutation and Iressa and Tarceva, drugs used to treat non-small cell lung cancer
  • KRAS, BRAF, and PIK3CA mutations and Erbitux and Vectibix, drugs used to treat colorectal cancer
  • EML4-ALK fusion gene and ALK inhibitor, a drug used to treat non-small cell lung cancer
  • PIK3CA mutation and mTOR or MEK inhibitor


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