ROCKVILLE, Md., Dec. 17, 2008 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) has entered into a Cooperative Research and Development Agreement (CRADA) with the Uniformed Services University of the Health Sciences (USU), an institution of higher learning within the Department of Defense (DoD), an agency of the United States Government, and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF), a private, not-for-profit organization that supports medical research and education at the university and the military medical community. The overall goal of the CRADA, which will involve researchers from USU's Infectious Disease Clinical Research Program (IDCRP) and Nabi, is to develop a licensed pentavalent S. aureus vaccine to prevent skin and soft tissue infection. The IDCRP has the mandate to design, conduct and publish collaborative clinical Infectious Disease research of importance to the DoD (and, also, the National Institute of Allergy and Infectious Diseases (NIAID)) through an effective research network that rapidly responds to evolving Infectious Disease threats.
"S. aureus infections remain a common cause of skin and soft tissue infections in troops during military training and deployment, as well as a common cause of wound infections in casualties returning from Iraq and Afghanistan. These infections adversely impact many active duty members and several phases of military operations, in addition to the well-being of U.S. citizens." commented Dr. David Tribble, Director, General Infectious Diseases, IDCRP. "We believe that investigating vaccine-based strategies is critical to prevent these common and serious infections both in military and civilian settings."
The CRADA proposes a series of collaborative clinical trials. These include: 1) Phase I evaluation of the safety and immunogenicity of the two toxoid compounds, Panton-Valentine Leukocidin (PVL) and alpha toxin; 2) Phase II evaluation of the safety and immunogenicity of a trivalent vaccine containing the capsular polysaccharide types 5 and 8 and cell wall polysaccharide type 336; and 3) Phase II evaluation of the safety and immunogenicity of the pentavalent vaccine containing all five components given in two separate, simultaneous doses.
"We are proud to collaborate with the USU and its IDCRP and HJF to further advance the development of Nabi's vaccine against S. aureus infection," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "With the additional resources this agreement brings to bear, Nabi is able to continue to advance the development of PentaStaph much further and much faster than we could have on our own. The escalating problem of Staphylococcus infection, in both the hospital and community settings, demands our best efforts to combat this growing threat."
About PentaStaph
PentaStaph(tm) (Pentavalent S. aureus Vaccine) is a five-component vaccine. Three of the antigen components induce antibodies that target S. aureus capsular polysaccharides Types 5, 8 and the cell wall antigen Type 336, which enhance the immune systems' ability to clear bacteria from the host. Types 5 & 8 capsular polysaccharides are expressed in approximately 80 percent of S. aureus strains, including many of the known MRSA (methicillin-resistant S. aureus) strains. Type 336 polysaccharide accounts for approximately 20% of S. aureus infections that do not form a polysaccharide capsule in the human bloodstream. Two additional antigen components induce antibodies that target two of the most predominant and virulent toxins produced by the bacteria which can significantly debilitate the human immune system: Panton-Valentine Leukocidin found predominantly in community-acquired MRSA, and alpha toxin, produced by almost all S. aureus isolates. This multi-target approach which enhances the immune system's ability to eliminate a broad spectrum of S. aureus strains and neutralizes the bacterial defenses of the most virulent strains has been demonstrated in pre-clinical models to provide optimal efficacy which is hoped would translate into human efficacy.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections. Nabi Biopharmaceuticals is currently developing NicVAX(r) (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse, and PentaStaph(tm) (Pentavalent S. aureus Vaccine), a vaccine designed to protect against the most dangerous and prevalent strains of S. aureus bacterial infections. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit our Web site:http://www.nabi.com.
About the Infectious Disease Clinical Research Program
The IDCRP was established in 2005 at the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD through an Interagency Agreement with the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID). The IDCRP is a DoD tri-service clinical research network, centrally administered at the USU, with several participating military treatment facilities and research and development commands across the United States. The program is executed through USU and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF). Current research within the IDCRP focuses on CA-MRSA, multi-drug resistant bacterial infections, trauma-related infections, travel and tropical medicine, and HIV/AIDS. For additional information about the IDCRP please visit our web site at www.idcrp.org.
Forward-Looking Statements
Statements in this release that are not strictly historical are forward-looking statements including statements about the development of our product candidates, and clinical trials and studies. You can identify these forward-looking statements because they involve our expectations, beliefs, projections, anticipations or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to our ability to: obtain successful clinical trial results; successfully develop product candidates; successfully pursue strategic and other alternatives; receive PhosLo milestone and royalty proceeds; successfully partner with third parties to fund, develop, and manufacture our pipeline products, including NicVAX and our gram-positive infections products; realize anticipated cost saving; attract and maintain the human and financial resources to bring to market products in development; depend upon third parties to manufacture our products; achieve approval and market acceptance of our products; enter into and maintain arrangements with third parties to market and sell our products; comply with reporting and payment obligations under government rebate and pricing programs; raise additional capital on acceptable terms, or at all; and re-pay our outstanding convertible senior notes when due. Many of these factors are more fully discussed, as are other factors, in the company's Annual Report on Form 10-K for the fiscal year ended December 29, 2007 filed with the Securities and Exchange Commission