Most chronic sinusitis cases are from fungal-induced inflamma

Sep 11 2007

Accentia Biopharmaceuticals announces evidence that most, if not all cases of chronic sinusitis (CS), are due to a fungal-induced inflammation as originally proposed by investigators at the Mayo Clinic.

The data were collected as part of the Company's ongoing pivotal Phase 3 clinical trial for its lead pharmaceutical product, SinuNase, an intranasal formulation of the antifungal amphotericin B 0.01% suspension. In order to be enrolled in the clinical trial, patients must have had well-documented CS based on a history of the requisite symptoms, nasal endoscopy findings, and CT scan demonstrating characteristic mucosal changes in the sinuses. At the time of enrollment, all patients have had nasal mucin collected. Subsequently, these specimens are being tested for eosinophilic major basic protein (eMBP). In the first fifty specimens now analyzed, all have been positive for eMBP, a toxic protein released by inflammatory cells in response to fungi. The Company believes that these findings strongly support a fungal-induced inflammation as the cause of CS.

SinuTest, the diagnostic used to measure eMBP in the nasal mucin, is a patented technology developed at the Mayo Foundation for Medical Education and Research. The technology is exclusively licensed to IMMCO Diagnostics, which has an exclusive commercialization agreement with Accentia Biopharmaceuticals. The Company believes that SinuTest will be a useful adjunct for identification of patients who are suspected of having CS and who may be candidates for treatment with SinuNase, assuming FDA approval.

As previously announced, Accentia has received Fast Track status from the Food and Drug Administration (FDA) for SinuNase, 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.

Despite the fact that there are over 60 million patients in the U.S. and EU that have CS, 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 for treatment of the disease. If approved, SinuNase will be the first therapy available to treat sufferers of CS.

Accentia Biopharmaceuticals is commercializing SinuTest for the confirmation of CS. Investigators at Mayo discovered that a ubiquitous, normally innocuous mold, Alternaria, colonizes in the mucus of the nose and sinus of virtually everybody. However, it was found that in patients with CS, this non-invasive mold elicits an eosinophilic inflammatory response characterized by the release of eMBP in the mucus, which then damages the mucosal epithelial lining of the nose and sinuses, leading to the inflammatory mucosal changes characteristic of CS. The SinuTest diagnostic uses a small sample of mucus from the patient's nose and tests for eMBP, which is uniquely detectable in the nasal mucin of patients with CS.