Sinusitis :: NIAID supports research into etiology of fungal-induced inflammation in chronic sinusitis

Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI; Accentia) reports that the Mayo Medical and Graduate Schools and the Virginia Bioinformatics Institute have been awarded a National Institute of Health (NIH) grant of $2.4 million for a project entitled “The Pathogenesis of Chronic Rhinosinusitis.”

The grant, in part, is to support identification of which antigens of the Alternaria fungus are responsible for the inflammation of chronic sinusitis (CS).

Accentia is the exclusive licensee to the Mayo patents covering the use of intranasal antifungals to treat chronic sinusitis using an already-approved antifungal, amphotericin B. for the life of the patents in the US and EU Accentia has also extended its exclusive option agreement with Mayo for worldwide rights to any and all other prescription antifungals for CS until December 6, 2008. Moreover, Accentia has a right of first refusal on any immunologic treatments developed based on identification of the specific fungal antigens responsible for CS and asthma.

The grant includes research on Alternaria alternata, the fungus that triggers the inflammatory response in susceptible patients with CS. The grant project will focus on identifying which antigens of Alternaria are the cause of CS. The funding of the program is a significant commitment of resources by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health. Because awarding of this grant is a peer-reviewed process, it represents a significant indication of the growing acceptance of the fungal etiology for CS.

The goal of the project is to positively impact treatment, clinical decisions, and medical care costs involving CS, as well as develop a better understanding of the mechanisms of the disease. Principal Investigator Hirohito Kita, professor of medicine at the Mayo Medical and Graduate Schools, will lead the project at Mayo Clinic, while Dr. Chris Lawrence, associate professor at VBI, will head the work at VBI in collaboration with VBI assistant professor Dharmendar Rathore. Researchers at Mayo, including clinical assistant professor Jens Ponikau, who is now at the University at Buffalo School of Medicine & Biomedical Sciences, and Hirohito Kita, professor of Immunology and the director of the Allergic Diseases Laboratory at Mayo, carried out extensive research at the Mayo Clinic which identified a fungal origin for CS.

Accentia Biopharmaceuticals is commercializing a diagnostic and developing a treatment for CS based on the published technology discovered at the Mayo Clinic. Investigators at Mayo discovered that a ubiquitous, normally innocuous mold, Alternaria, colonizes the mucus of the nose and sinus of virtually everybody, but in patients with CS, this non-invasive mold elicits an eosinophilic inflammatory response characterized by release of eosinophil major basic protein (eMBP) in the mucus, which then damages the mucosal epithelial lining of the nose and sinuses and leads to the inflammatory mucosal changes characteristic of CS.

Dr. Jens Ponikau, Assistant Professor of Clinical Otolaryngology, University at Buffalo, commented: ?Research supported by the National Institutes of Health had previously shown that CS patients have an exaggerated immune response to certain fungi, specifically Alternaria species. The patients reacted to the fungi with the production of the inflammatory mediators, which are crucial for the inflammation in CS, whereas healthy subjects were not reacting. The renewal of the NIH grant will allow Dr. Kita and Dr. Lawrence to further pinpoint the mechanism by which the fungus causes the inflammation, and specifically what fungal products are involved. Both are important milestones to deepen our understanding about CS, and will help us to better understand the mechanism of action of newer treatment approaches, such as anti-fungal therapy.?

As previously announced, Accentia has received Fast Track status from the Food and Drug Administration (FDA) for SinuNaseTM, and it is conducting a randomized, double-blind, placebo-controlled Phase 3 clinical trial with severe CS patients at more than 50 sites across the U.S. To the knowledge of the Company, this is the first and only Phase 3 clinical trial for CS and the only intranasal antifungal that has been submitted to the FDA as an Investigative New Drug (IND). The initial study population is with patients that have severe CS who have undergone sinus surgery, but who are struggling with recurrent CS. Accentia intends to provide an update on the Phase 3 trial on June 27th.

Despite the fact that there are an estimated 31 million affected U.S. patients, and that CS is by far the most common chronic respiratory disease with a commercial market approximately twice the size of asthma, there is currently no approved prescription pharmaceutical available. If approved, SinuNase will be the first therapy available to treat sufferers of CS.

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