Accentia results support fungal infection theory in chronic sinusitis

The data were collected as part of the company's ongoing pivotal trial for 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 chronic sinusitis (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. Accentia believes that these findings strongly support a fungal-induced inflammation as the cause of CS.

Mayo Clinic researchers discovered that the cause of chronic sinusitis was an immune reaction to a fungal infection, not an allergy or a bacterial infection as was previously thought. In 2004, Accentia acquired a license from the clinic that gave the company the exclusive worldwide right to market and sell products based on Mayo Clinic's patented treatment method using amphotericin B.