SinuNase™

SinuNase Therapy for Chronic Rhinosinusitis

Our first product candidate, SinuNase™, is an amphotericin B suspension that is self-administered into a patient’s nasal cavity for the treatment of chronic rhinosinusitis, or CRS. Rhinosinusitis is an inflammatory condition of the paranasal sinuses that results in a variety of symptoms, including nasal congestion, facial pain and pressure, nasal discharge, and headaches. Rhinosinusitis is estimated to affect approximately 35 million Americans, and an estimated 90% of all rhinosinusitis cases are chronic. Of CRS sufferers, up to 500,000 people resort to sinus surgery each year. Historically, the treatment of CRS has largely focused on addressing the symptoms of the condition through acute antibiotic therapy, intranasal or oral corticosteroids, and sinus surgery. While antibiotics are useful in treating the acute exacerbations that result from the bacterial invasion of the damaged paranasal tissue of CRS patients, no antibiotic has proven effective in eradicating the underlying cause of CRS. Intranasal and oral corticosteroids, which are potent anti-inflammatory hormones, have been used to reduce the inflammation that plays a role in CRS, but oral corticosteroids can cause serious side effects and must be avoided or cautiously used with patients that have certain conditions, such as gastrointestinal ulcers, renal disease, hypertension, diabetes, osteoporosis, thyroid disorders, and intestinal disease. Surgery is frequently used in CRS patients to improve the drainage of their sinuses based on the assumption that the disease can be reversed by identifying and correcting the obstruction that caused the condition, but while such surgery usually offers temporary relief of symptoms, it is typically not curative. If approved by the FDA, we expect that SinuNase would be the first pharmaceutical product indicated for the treatment of CRS.

Patient Information: Read about Chronic Rhinosinusitis at Accentia's Sinus Education Center.

SinuNase Studies at the Mayo Clinic

Mayo Clinic has conducted published studies on CRS demonstrating that airborne fungi play a significant role in CRS and that the condition can be substantially relieved by treating patients with a low-dose intranasal application of antifungals, such as an amphotericin B. Other formulations of amphotericin B are currently approved by the FDA as antifungals for other indications. In one open label study by Mayo Clinic with 51 CRS patients treated with an amphotericin B solution, 75% of the patients experienced improvement in sinus symptoms over a treatment course that averaged 11.3 months. In addition, in a study conducted by Mayo Clinic and published in the January 2005 Journal of Allergy and Clinical Immunology, Mayo Clinic reported results of a small controlled clinical trial that demonstrated a statistically significant difference between an amphotericin B treatment group and a control group. To date, the published clinical studies have not disclosed any serious adverse events associated with the intranasal application of amphotericin B.

In February 2004, we acquired a license from the Mayo Foundation for Medical Education and Research that, as amended, gives us the exclusive worldwide right to market and sell products based on Mayo Clinic’s patented treatment method using amphotericin B. Mayo Foundation holds an issued U.S. patent and a European Union counterpart patent application covering the use of intranasal antifungals for the treatment of CRS. It also holds a U.S. patent for the use of muco-administered antifungals for the treatment of asthma, and in December 2004, we amended our license with Mayo Foundation granting us rights to this therapy using amphotericin B. Under our license, we are developing SinuNase as a self-administered therapy delivered into the patient’s nasal cavity to relieve the symptoms associated with CRS.

We elected to license amphotericin B for our CRS therapy as a result of its favorable clinical and regulatory characteristics. To our knowledge, it is the only intranasal antifungal used by Mayo Clinic or others in their published studies on CRS, and amphotericin B is generally recognized as being very unlikely to induce drug resistance among fungi. As a fungicidal, amphotericin B is powerful enough to kill fungi, rather than merely impair their growth. Also, amphotericin B, when applied topically, has minimal absorption into a patient’s mucus membrane, which makes it possible to apply an effective dose to the fungi in the mucus with a low risk for systemic exposure to the patient. As an approved and extensively-characterized therapeutic for other indications, we believe the use of amphotericin B for our CRS therapy should provide for an expedited regulatory approval process.