Guest guest Posted April 28, 2002 Report Share Posted April 28, 2002 Candidate Therapy Designed to Protect Against Hepatitis C Following Liver Transplants Rockville, land, 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 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 addiction. 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 addiction. 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, land. 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. Contacts: J. Gury, Chairman, President and CEO, (561)-989-5800 Mark L. , Sr. V.P., Finance and CFO, (561)-989-5800 Investor Relations: Janet Dally, MontRidge, LLC, 203-894-8038, 609- 466-0466 Media Contact: Joan Kureczka, Kureczka/ Associates, 415-821-2413 __________________________________________________ Quote Link to comment Share on other sites More sharing options...
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