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Lupus Clinical Trials

New Medical Therapies™

Sinus Infections

March 31, 2008

Accentia reported negative results from a phase III trial of SinuNase for the treatment of chronic sinusitis. This double-blind, placebo-controlled, randomized comparison trial enrolled three hundred subjects with chronic sinusitis who were refractory to surgery. The subjects were randomized to receive SinuNase or placebo for sixteen weeks. The primary endpoint was the resolution of the symptoms of chronic sinusitis. Secondary endpoints included endoscopy scores and sinus mucosal thickening on CT scan. Data is from un-blinded analysis showed that the primary endpoint was not reached. While SinuNase achieved superior resolution of the cardinal symptoms of chronic sinusitis as compared to placebo, the primary endpoint data did not show the required level of statistical significance (p-value = 0.14). Secondary endpoints were reached; all of the subjects (100%) had their nasal mucus test positive for eMBP (eosinophilic major basic protein positive). Full results are expected in April at which time Accentia plans to meet with the FDA to determine a future course of action for SinuNase.

August 20, 2007

Accentia reported positive interim results from a phase III trial of SinuNase for the treatment of chronic sinusitis. This double-blind, placebo-controlled, randomized trial has enrolled 80 surgery-refractory subjects to date. The primary endpoint was complete resolution of both key cardinal symptoms of chronic sinusitis at 16 weeks. Interim blinded analysis of the SinuNase cohort revealed an improvement in polyposis by endoscopy and improvement in sinus inflammation by CT scan in approximately 50% of subjects. In addition, the data shows that almost 50% of these subjects with objective evidence of improvement have achieved the primary endpoint of complete resolution of the two key cardinal symptoms. Accentia plans to complete enrollment in this trial by the end of August 2007.

July 9, 2007

Accentia reported positive interim results from a phase III trial of SinuNase for the treatment of chronic sinusitis. This double-blinded comparison trial planned to enroll 300 subjects with chronic sinusitis who are refractory to surgery. Results were reported from the first 50 treated subjects. Subjects were to be randomized to receive SinuNase or placebo for 16 weeks. The primary endpoint was resolution of the cardinal symptoms of chronic sinusitis. At 8 weeks post-randomization, SinuNase demonstrated substantial improvement in resolution of one or both of the cardinal symptoms of chronic sinusitis, and substantial improvement in intranasal polyposis, with 42% of the subjects reporting this. Of the evaluated subjects, 47% showed improved endoscopy scores .Enrollment was expected to be complete by the end of the summer with un-blinded results available before the end of 2007.

October 17, 2005

Oscient Pharmaceuticals has announced positive results of phase III trials of Factive (gemifloxacin mesylate) tablets, for the treatment of acute bacterial sinusitis (ABS) and acute bacterial exacerbations of chronic bronchitis (AECB). Pooled retrospective results from their phase III ABS program indicated that Factive was significantly superiority to approved therapies (cefuroxime and trovafloxacin) in both clinical success at end of therapy (89.3% vs. 77%; p=0.01) and in clinical success at follow-up (79.9% vs. 66.3%; p=0.019). Pooled data from the company's 10 AECB trials indicated non-inferiority of clinical response compared to a number of approved therapies (including clarithromycin, levofloxacin, trovafloxacin, amoxicillin-clavulanate, ceftriaxone/cefuroxime and ofloxacin). Factive is currently approved to treat AECB and community-acquired pneumonia; in is still under investigation for ABS.

June 20, 2005

Naryx Pharma announced positive results of a phase II study of their investigational nebulizable nasal antibiotic SPRC- AB01, for the treatment of chronic rhinosinusitis. Preliminary results from the study met their primary endpoint, with subjects in the high dose cohort achieving a statistically significant reduction in the signs and symptoms of chronic rhinosinusitis at the end of treatment, compared to placebo. Furthermore, the drug was seen to be safe and well tolerated, with overall incidence of adverse events seen to be comparable between both drug dosing cohorts and placebo. This double-blind, placebo-controlled, multi-center study enrolled 58 post-surgical patients with chronic rhinosinusitis, who received either low or high dose SPRC-AB01 or placebo via nebulizer twice daily for 21 days.

March 18, 2002

Phase III trial results indicate that Ketek (telithromycin) is active in subjects with acute maxillary sinusitis (AMS). The multicenter, double-blind trial included adult and adolescent subjects with clinical signs and symptoms of AMS. Of 252 subjects treated with Ketek, 27 had S. pneumoniae isolates with an eradication rate of 88.9%. Fourteen subjects had pretreatment isolates resistant to penicillin G and/or erythromycin A. In these subjects with resistance microorganisms, a total of 93% of isolates were susceptible to Ketek, and 85.7% achieved satisfactory clinical and bacteriological outcomes. Ketek is being developed by Aventis.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.