Candidate Therapy Designed to Protect Against Hepatitis C Following Liver Transplants
- Candidate Therapy Designed to Protect Against Hepatitis C Following
Rockville, Maryland, April 17, 2002 - Nabi Biopharmaceuticals
(Nasdaq: NABI) announced initiation of a Phase I/II clinical trial
for its investigational product,Civacir [Hepatitis C Immune Globulin
(Human)]. Civacir is an antibody-based therapy being developed to
prevent hepatitis C virus (HCV) re-infection of transplanted livers
in patients suffering from hepatitis C.
"Beginning human trials of Civacir is an important corporate and
clinical milestone for Nabi Biopharmaceuticals," said David J. Gury,
chairman, president and CEO. "There is a significant unmet medical
need for this kind of product in liver transplant patients suffering
from 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
Biopharmaceuticals on August 31, 1999.
The clinical trial is sponsored by the National Institute of Allergy
and Infectious Diseases (NIAID), a part of the National Institutes of
Health, and is being conducted by the NIAID Collaborative Anti-Viral
Study Group at five study sites in the U.S.
To manufacture Civacir, Nabi Biopharmaceuticals collects HCV-antibody
enriched plasma at its network of FDA licensed antibody collection
centers. This raw material is then pooled and manufactured at Nabi
Biopharmaceuticals' state-of-the-art manufacturing facility in Boca
Raton, Florida. Through a process called fractionation, antibodies in
the plasma are separated from other plasma components and then
further purified and concentrated to make the clinical trial material
Approximately 4 million people in the U.S. and 175 million people
worldwide are infected with HCV. An estimated 85 percent of acutely
infected individuals become chronic carriers of HCV, a condition that
can often result in insidiously progressive liver disease. The
Centers for Disease Control and Prevention (CDC) report that
approximately 5 percent of those infected with HCV develop liver
failure or liver cancer and require a liver transplant in order to
survive. Of the nearly 5,000 liver transplants performed in the U.S.
in 1999, approximately 40 percent were due to complications from HCV.
Civacir joins Nabi Biopharmaceuticals' three other investigational
products that are or will be in human clinical trials in 2002. These
include, StaphVAX (Staphylococcus aureus Polysaccharide Conjugate
Vaccine), a vaccine being developed for patients who are at high risk
of contracting a Staphylococcus aureus infection; Altastaph
[Staphylococcus aureus Immune Globulin Intravenous (Human)], an
intravenous immune globulin being developed to provide immediate
protection for patients who are at high, short-term risk of
contracting a S. aureus infection; and NicVAX(Nicotine Conjugate
Vaccine), a vaccine being developed to prevent and treat nicotine
Nabi Biopharmaceuticals discovers, develops, manufactures and markets
products that power the immune system to help people with serious,
unmet medical needs. The company has a broad product portfolio and
significant research capabilities focused on developing and
commercializing novel vaccines and antibody-based therapies that
prevent and treat infectious, autoimmune and addictive diseases, such
as Staphylococcus aureus and hepatitis infections, ITP, and nicotine
Nabi Biopharmaceuticals has several products in clinical trials, as
well as four marketed products, including Nabi-HB [Hepatitis B Immune
Globulin (Human)], for the prevention of hepatitis B infections and
WinRho SDF, [Rho(d) Immune Globulin Intravenous (Human)], for the
treatment of acute, chronic and HIV-related immune thrombocytopenia.
The company is headquartered in Boca Raton, Florida, with principal
R&D offices and laboratories in Rockville, Maryland. Additional
information about Nabi Biopharmaceuticals may be obtained on the
company's Web site at www.nabi.com.
Civacir is a human antibody product derived from screened donors. It
contains antibodies that are neutralizing to hepatitis C virus
("HCV"). Nabi intends to develop Civacir for the prevention of HCV
reinfection of transplanted livers, post-exposure prophylaxis of HCV,
and ultimately for the treatment of certain stages of chronic HCV
infections. Approximately 40% to 50% of liver transplants are due to
complications resulting from chronic HCV infections.
HCV has significant economic impact because it causes chronic
infections in a large percentage of those infected and results in
significant morbidity and mortality in later stages of the disease.
HCV infection also contributes to frequent hospitalizations when it
occurs in liver transplant patients. There are four million
individuals in the United States and more than 170 million
individuals worldwide infected with HCV.
In 1998, Nabi initiated a series of chimpanzee studies of Civacir in
collaboration with the CDC under a CRADA. The results from these
animal studies suggest that the elevated level of anti-HCV in serum
maintained by multiple infusions of Civacir may be associated with
the elimination of virus from the blood, prevention of acute
hepatitis and the possible elimination of HCV antigen from liver
cells after experimental HCV infection.
David J. Gury, Chairman, President and CEO, (561)-989-5800
Mark L. Smith, Sr. V.P., Finance and CFO, (561)-989-5800
Investor Relations: Janet Dally, MontRidge, LLC, 203-894-8038, 609-
Media Contact: Joan Kureczka, Kureczka/Martin Associates,
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