The US National Institutes of Health Recombinant DNA Advisory Committee has concurred with earlier conclusions that a patient death during a trial of Targeted Genetics’ injectable anti-arthritis drug,
United States of America (Press Release) December 13, 2007 --
The US National Institutes of Health Recombinant DNA Advisory Committee has concurred with earlier conclusions that a patient death during a trial of Targeted Genetics’ injectable anti-arthritis drug, tgAAC94, this summer was not caused by the drug.
At its meeting on December 3rd, the RAC said there were insufficient data available to determine if the trial participant had an immune response to the tgAAC94 injection. However, if there was such a response, it was unlikely to have been a significant contributor, if at all, to her clinical course, and was not the cause of death.
The RAC agreed that the subject’s death was a result of complications from disseminated histoplasmosis, which caused a retroperitoneal haematoma and multi-organ failure. The Committee noted that an apparent risk factor that might have had an impact on the patient’s susceptibility to the infection was her longstanding systemic treatment for rheumatoid arthritis with TNF antagonist adalimumab.
The study's independent data safety monitoring board had reached the same conclusion on October 23rd and the US Food and Drug Administration lifted its clinical hold on the Phase I/II trial last month. Article submitted by www.jobs4dd.com, for latest news and clinicl research jobs in the drug development sector.
At its meeting on December 3rd, the RAC said there were insufficient data available to determine if the trial participant had an immune response to the tgAAC94 injection. However, if there was such a response, it was unlikely to have been a significant contributor, if at all, to her clinical course, and was not the cause of death.
The RAC agreed that the subject’s death was a result of complications from disseminated histoplasmosis, which caused a retroperitoneal haematoma and multi-organ failure. The Committee noted that an apparent risk factor that might have had an impact on the patient’s susceptibility to the infection was her longstanding systemic treatment for rheumatoid arthritis with TNF antagonist adalimumab.
The study's independent data safety monitoring board had reached the same conclusion on October 23rd and the US Food and Drug Administration lifted its clinical hold on the Phase I/II trial last month. Article submitted by www.jobs4dd.com, for latest news and clinicl research jobs in the drug development sector.
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