Wednesday March 26 8:45 AM EDT
NABI Announces that Data Board Has Recommended Discontinuing Enrollment in NIH HIV-IG(TM) Trial Due to Success of AZT in Reducing HIV Vertical Transmission
BOCA RATON, Fla., March 26 /PRNewswire/ -- NABI Inc announced today that due to an unexpectedly low rate of infant infection, the Data Safety Monitoring Board (DSMB) has recommended that the National Institutes of Health (NIH) discontinue patient enrollment in its Phase III clinical trial of HIV-IG(TM). The decision was made in light of the fact that current therapy using AZT has reduced the rate of mother to baby HIV transmission so low that it is not feasible to show statistically significant efficacy for a combination of AZT and HIV-IG(TM). There were no safety issues pertaining to HIV-IG(TM).
"We share the NIH's gratification that the prospects for babies of HIV- infected mothers have improved so dramatically," said David J. Gury, President and CEO of NABI. "Moreover, HIV-IG(TM) may still play a role in HIV therapy, and we plan to continue our Phase II dosing study to test the product's safety and efficacy in the treatment of HIV-infected children." The NIH-sponsored pediatric study of IV-IG(TM) is fully enrolled, and completion is expected during 1997.
"With respect to NABI's product pipeline, we have numerous products in development for infectious diseases, including hepatitis, staph infections and cytomegalovirus. Our strategy, as reflected by our currently marketed immunotherapeutic products H-BIG(R) and WinRho SD(R), is to focus on areas where treatments are either non-existent or inadequate due to drug resistance," Mr. Gury explained.
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 autoimmune and infectious diseases. NABI markets two immunotherapeutic products: H-BIG(R), for the prevention of hepatitis B, and WinRho SD(R), for the treatment of Immune Thrombocytopenic Purpura (ITP, an immune platelet disorder), and for the suppression of Rh soimmunization. Clinical trials designed to expand the clinical
indications are underway for both marketed products. SOURCE NABI
NABI share traded as low as 6 7/8 in early morning trading, and now on its way to recovery.
Xy |
