Clinical Trials of Nabi Biopharmaceuticals' Civacir Commence
"Beginning human trials of Civacir is an important corporate and
clinical milestone for Nabi Biopharmaceuticals," said David J Gury,
chairman, president and CEO.
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"There is a significant unmet medical need for this kind of product
in liver transplant patients suffering from hepatitis C virus (HCV)
infection. Re-infection by HCV is nearly universal in patients who
have received liver transplants due to chronic HCV infection.
Civacir, if successful in clinical trials and approved by FDA, would
be the first therapy specifically developed to help protect patients
from HCV following liver transplant surgery."
The phase I/II study of Civacir is a randomized, controlled clinical
trial and will evaluate two dose levels of Civacir. The clinical
trial will evaluate the safety and antibody levels of Civacir, as
well as its effects on the level of virus circulating in the
patients' blood and in the transplanted livers.
Results of a study in chimpanzees suggested that multiple infusions
of Civacir were effective in the early termination of HCV infections
in animals challenged with various doses of HCV as reported by Nabi
on August 31, 1999.
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