AEGiS-PRn: North American Biologicals, Inc. Expands Early Clinical Program to Prevent Staph Infections in Immune Compromised Patients

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

North American Biologicals, Inc. Expands Early Clinical Program to Prevent Staph Infections in Immune Compromised Patients

PR Newswire - December 12, 1995

NEW YORK, Dec. 12 /PRNewswire/ -- North American Biologicals, Inc. (NABI) (Nasdaq: NBIO) today announced the expansion of its donor stimulation program for StaphGAM(TM), a product intended to prevent Staphylococcus aureus infections (Staph infections) in hospitalized patients. In the United States there are approximately 3 million people who run the risk of developing staph infections in hospitals. The data gathered in this study will be used to assist NABI in producing clinical trial quantities of StaphGAM(TM), which is expected to commence human Phase I trials in late 1996.

Speaking at the Raymond James Conference in New York, David J. Gury, NABI's President, Chairman, and CEO, stated, "StaphGAM(TM) has the potential to serve as an effective agent in combating hospital-acquired bacterial infections and addressing this $500 million market." Mr. Gury added, "StaphGAM(TM) is the sixth product in our pipeline slated to enter human clinical trials, and we are encouraged by its progress."

Commenting on the pre-clinical data on StaphGAM(TM) presented at the 1995 Gordon Conference on Staphylococcal Diseases in Irsee, Germany in September of 1995, Tom Stagnaro, NABI's Senior Executive Vice President, stated, "The data were very promising, showing that StaphGAM(TM) reduced the occurrence of S. aureus endocarditis, an inflammation of the inner layer of the heart, by up to 80% in animal models." Mr. Stagnaro added, "In several animal challenge models StaphGAM(TM) also significantly reduced the number of staph bacteria which survived in the blood, livers and kidneys after experimental infection."

Mr. Stagnaro noted that the StaphGAM(TM) donor stimulation program currently underway is intended to maximize antibody production in donors by evaluating the impact of different dosing regimes and differing antibody collection schedules. Once NABI has determined that StaphGAM(TM) is stimulating the optimum levels of staph-fighting antibodies in donors, the Company plans to expand the number of donors being immunized, and begin producing trial quantities of StaphGAM(TM) in mid 1996.

NABI's donor stimulation program for StaphGAM(TM), which was initiated in September 1995, comprises 70 healthy adults who are vaccinated with StaphVAX(TM), the staph vaccine that NABI has licensed from the NIH to stimulate the production of high levels of antibodies against staph in plasma donors. These antibodies are then purified and formulated into a specific polyclonal antibody treatment called StaphGAM(TM). StaphGAM(TM) may provide immediate protection to patients who are at risk of contracting hospital-related staph infections. These individuals include severe trauma patients, and those undergoing cardiac, vascular graft and joint replacement surgery.

North American Biologicals, Inc., headquartered in Boca Raton, Florida, is a top-tier biopharmaceutical company focused on the development, manufacturing, and marketing of products that prevent and treat autoimmune and infectious diseases and related complications through the activation and targeting of the human immune system. NABI currently has eight products in its clinical pipeline for indications including HIV, Staph infections, lung infections in Cystic Fibrosis patients, and Cytomegalovirus. NABI also has two immunotherapeutic products already on the market: H-BIG(R), for the prevention of Hepatitis B and WinRho SD(TM), for the treatment of Immune Thrombocytopenic Purpura, an immune blood disorder.

CONTACT: David J. Gury, Chairman, President and CEO of North American Biologicals, Inc., 407-989-5800, or Lucy L. Morrison, Account Executive of Feinstein Partners Inc., 617-577-8110/ 10:29 EST

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