Newswise — Sinusitis, inflammation of the sinus passages around the
nose and throat, is one of the most common illnesses in the United
States, affecting between 30 and 40 million people each year, and
triggering between 18 and 22 million doctor visits. Among the symptoms
are nasal congestion, thick mucus production, headaches, tenderness in
the face, and aching behind the eyes. Chronic sinusitis persists for
weeks, months, or longer, causing misery for sufferers. In the most
severe cases the sinus cavity clogs, preventing drainage of mucous and
making it difficult to breathe through the nose.

Prior to the research on fungal etiology, the prevailing opinion among
the healthcare community was that upper respiratory infections such as
colds and flu caused chronic sinusitis by damaging the upper
respiratory epithelium. Within the last decade, physicians at the Mayo
Clinic hypothesized that most cases of chronic sinusitis were caused
not by epithelial dysfunction, but by an inflammatory reaction to the
presence of fungi in the mucus. This novel idea was initially rejected
by medical specialists, but in a few short years, evidence in favor of
the fungal etiology of chronic sinusitis has accumulated. Surveys of
ear, nose, and throat specialists (ENTs, also known as
otolaryngologists) and allergists revealed that a large number of the
specialists treating this disease have adopted the theory that an
inflammatory response to fungus in susceptible patients (almost 10%) is
the cause of Chronic Sinusitis.

Accentia Biopharmaceuticals has conducted three surveys, presented at a
recent American College of Allergy, Asthma and Immunology symposium.
The surveys revealed that prevailing perceptions among ENT’s
regarding the possible fungal cause of chronic sinusitis, especially
for patients who do not benefit from surgery to correct chronic
sinusitis. This group of patients is classified as “surgery
refractory.”

The first two surveys suggested that ENTs in the United States saw up
to twice as many patients with chronic sinusitis as their counterparts
in Germany, France, and the United Kingdom. Approximately 25% of their
chronic sinusitis patients were refractory to surgery, meaning their
condition does not improve after an operation to remove sinus tissue.
In addition, 90% of US and EU (European Union) specialists expressed
dissatisfaction with current treatment options for chronic sinusitis,
and acknowledged the significant impact to quality of life associated
with this condition.

The third survey polled eighty American ENTs and allergists to
determine the physicians’ prevalent belief regarding the etiology, or
cause of chronic sinusitis. In this survey, three-quarters of
physicians (75%) attributed the root cause of chronic sinusitis to a
fungal infection, and 84% believed that surgery-refractory patients
were more likely to fall into the fungal etiology category. Sixty-nine
percent of specialists surveyed considered intranasal antifungal drug
therapy to be an appropriate treatment for chronic sinusitis patients,
with 74% supporting this approach for surgery-refractory patients.

“Fungal etiology is gaining greater acceptance among U.S. and
European physicians,” noted Angelos Stergiou, MD, Medical Director at
Accentia Biopharmaceuticals. Accentia is currently planning to test the
effects of SinuNase™, an intranasal form of Amphotericin B, in
patients with chronic sinusitis. SinuNase belongs to a class of
medicines known as anti-fungals.

The seriousness of chronic sinusitis, and the potential of SinuNase to
become the first approved treatment for treating this condition
prompted Accentia to seek "Fast Track" status for this drug. In
response to this application, the U.S. Food and Drug Administration
granted “Fast Track” status for SinuNase in April 2006. For more
information on the clinical trials and their location, please visit
http://www.accentia.net