BOCA RATON, Fla., Aug. 10 /PRNewswire/ -- Nabi(TM)
(Nasdaq: NABI - news) announced today that scientists studying
Nabi-Civacir(TM) in chimpanzees reported results of two separate
studies at the 5th International Meeting on Hepatitis C Virus and
Related Viruses in Venice, Italy, June 25-28, 1998. Nabi-Civacir is
an experimental human polyclonal antibody preparation produced by
Nabi from the plasma of hepatitis C virus (HCV) antibody-positive
donors and is being investigated for the prevention and treatment
of HCV infections.
The death toll from hepatitis C is rising, with approximately 10
thousand deaths per year attributable to this insidious virus. It
is estimated that currently 4 million Americans are infected with
HCV and up to 180 thousand new cases of this viral infection are
reported per year.
The first animal study, originating from a Cooperative Research
and Development Agreement (CRADA) between Nabi and the Centers for
Disease Control (CDC), was reported by Dr. K. Krawszynski of the
Hepatitis Branch of the CDC. Dr. Krawszynski described preliminary
results of multiple intravenous infusions of Nabi-Civacir
administered over an 89-day period to a chimpanzee after
experimental infection of the animal with HCV. Similarly, a control
chimpanzee was experimentally infected with HCV and subsequently
dosed with multiple infusions of a human polyclonal antibody
preparation that was free of HCV antibodies. Although both
chimpanzees became infected as indicated by detection of HCV RNA in
sera samples by PCR and HCV antigen in liver cells by EIA, only the
control chimpanzee progressed to symptoms of hepatitis as measured
by elevation of ALT liver enzymes and characteristic
histopathology. While ALT liver enzymes increased steadily
throughout the 89 days of dosing in the control animal, liver
enzymes remained normal in the Civacir-treated chimpanzee
throughout the dosing period. In addition, although HCV RNA levels
and HCV antigen levels increased steadily in the control animal
throughout the dosing period, the Civacir-treated animal became HCV
antigen negative and HCV RNA negative and remained so after about
42 days of dosing.
Dosing of both control and Civacir-treated chimpanzees was ended
on day 89, and the chimps continue to be followed to determine the
long-range effects of the earlier treatment. These results from
ongoing animal studies suggest that the elevated level of anti-HCV
in serum maintained by multiple infusions of Nabi-Civacir may be
associated with early termination of viremia and the possible
elimination of HCV antigen from liver cells during experimental HCV
infection.
In a separate investigational study also reported at the
meeting, Dr. M.W. Yu of the Division of Hematology, Center for
Biologics Evaluation and Research, Food and Drug Administration,
described the results of a study in which the HCV-neutralizing
capabilities of Nabi-Civacir was evaluated in chimpanzees. In this
study, HCV was incubated in vitro with either Nabi- Civacir, or
with albumin, or with standard intravenous immune globulin prior to
its injection into chimpanzees. Both control animals developed
evidence of HCV infection (HCV RNA and elevated ALT levels, and
later anti-HCV) within 10 weeks, whereas the animal receiving HCV
mixed with Nabi-Civacir has been followed for more than 1 year
without evidence of infection. These results suggest that
neutralizing antibodies to HCV are present in Nabi-Civacir, which
is prepared from virally-inactivated anti-HCV positive donor units,
and that such a product might be useful in the future for the
prophylaxis or possible treatment of HCV infections.
There were no adverse effects of Nabi-Civacir in either of the
chimp studies and additional studies will evaluate the safety of
the drug.
``We are excited about these preclinical results with
Nabi-Civacir in what we believe to be a relevant model of hepatitis
C virus infection,'' declared Dr. Robert Naso, Sr. Vice President.
``Nabi intends to develop Nabi-Civacir for the prevention of
reinfection of transplanted livers in transplant patients and
ultimately, for the treatment of chronic hepatitis C infections.
Nabi currently markets a drug for prevention of Hepatitis B
infections, and we believe that the potential addition of Civacir
for HCV infections could substantially broaden our presence in the
anti-viral field. Nabi is seeking a development partner for
Civacir.''
Nabi, a fully integrated biopharmaceutical company, has a broad
product portfolio and significant R&D capabilities focused on
the development and commercialization of products that prevent and
treat infectious and autoimmune diseases. Nabi currently has five
clinical trials underway in these areas and has three
immunotherapeutic products already on the market.
This release contains forward-looking statements which involve
risks and uncertainties. The Company's actual results may differ
significantly from results discussed in the forward-looking
statements due to a number of factors, including, but not limited
to, the uncertainty of product development; government regulations
and the uncertainty of regulatory approval; and dependence upon
third parties to manufacture product. These factors are more fully
discussed in the Company's most recent Form 10-K filed with the
Securities and Exchange Commission.
SOURCE: Nabi
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