Loading ...
Sorry, an error occurred while loading the content.

Candidate Therapy Designed to Protect Against Hepatitis C Following Liver Transplants

Expand Messages
  • claudine intexas
    Candidate Therapy Designed to Protect Against Hepatitis C Following Liver Transplants Rockville, Maryland, April 17, 2002 - Nabi Biopharmaceuticals (Nasdaq:
    Message 1 of 1 , Apr 28, 2002
      Candidate Therapy Designed to Protect Against Hepatitis C Following
      Liver Transplants

      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,

      Do You Yahoo!?
      Yahoo! Health - your guide to health and wellness
    Your message has been successfully submitted and would be delivered to recipients shortly.