Preliminary Results with Nabi Hepatitis C Drug in Chimpanzees


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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.


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