Sylvana Research Release: Ciclesonide Data Presented At American Academy of Allergy, Asthma and Immunology (AAAAI)

MIAMI BEACH, Fla., March 5 /PRNewswire/ -- The investigational drug, ciclesonide, was significantly superior to placebo in relieving nasal symptoms, and provided appreciable improvement in health-related quality of life in adult and adolescent patients with seasonal allergic rhinitis, according to clinical data presented today at the 2006 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.

Ciclesonide is an intranasal corticosteroid under investigation for the treatment of perennial and seasonal allergic rhinitis. The study, "Efficacy and Safety of Ciclesonide Nasal Spray for the Treatment of Seasonal Allergic Rhinitis," was presented by Paul H. Ratner, M.D., Sylvana Research, San Antonio, Texas.

According to Dr. Ratner, intranasal corticosteroids are considered the most effective treatment for the management of allergic rhinitis symptoms. "These clinical data are encouraging and support the continued development of safe, effective and tolerable treatment options for patients with allergic rhinitis," he said.

Trial Design and Results Seasonal Allergic Rhinitis * In a phase III, double-blind, placebo-controlled trial, patients with seasonal allergic rhinitis (age greater than or equal to 12 years) were randomized to receive intranasal ciclesonide 200 micrograms (n = 164) or placebo (n = 163) once daily for 28 days. * Patient-assessed total nasal symptom score, physician-assessed overall nasal signs and symptoms severity, and Rhinoconjunctivitis Quality-of- Life Questionnaire were evaluated. Adverse events were monitored throughout the study. * Ciclesonide showed similar improvements in both am and pm placebo-adjusted reflective total nasal symptom score, suggesting a 24- hour effect. * Ciclesonide was well tolerated, with a safety profile comparable with placebo and the epistaxis rate was 1.8%. * Data supports the continued clinical development of ciclesonide nasal spray. About Sylvana Research

Sylvana Research has been conducting research on investigational medications for approximately 22 years. Sylvana Research performs research studies year round for indications such as allergies, asthma, hypertension and psoriasis. Sylvana Research is contracted by the pharmaceutical industry to perform these studies, to help gain FDA approval for the medication.

Efficacy and Safety of Ciclesonide Nasal Spray for the Treatment of Seasonal Allergic Rhinitis

PH Ratner,(1) JH van Bavel,(2) F Hampel,(3) PF Darken,(4) N Hall,(4) T Shah,(4) MA Wingertzahn(4)

(1) Sylvana Research, San Antonio, TX; (2) Allergy & Asthma Associates, P.L.L.C., Austin, TX; (3) Central Texas Health Research, New Braunfels, TX; (4) Altana Pharma, Florham Park, NJ

Rationale: Intranasal corticosteroids are considered the most effective treatment for the management of allergic rhinitis (AR) symptoms. The objective of this study was to evaluate the efficacy and safety of a new corticosteroid in development for the treatment of asthma and AR, ciclesonide (CIC), in patients with seasonal AR (SAR).

Methods: In this phase III, double-blind, placebo-controlled trial, patients with SAR (age greater than or equal to 12 years) were randomized to receive intranasal CIC 200 micrograms (n = 164) or placebo (n = 163) once daily for 28 days. Patient-assessed total nasal symptom score (TNSS), physician-assessed overall nasal signs and symptoms severity (PANS), and Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) were evaluated. Adverse events (AEs) were monitored throughout the study.

Results: Ciclesonide significantly improved the average of am and pm reflective TNSS and instantaneous TNSS versus placebo from Days 1 through 14 (primary endpoint) and over the 28-day treatment period (p < 0.001). Furthermore, CIC showed similar improvements in both am and pm placebo-adjusted reflective TNSS, suggesting a 24-hour effect. At Day 15, CIC improved RQLQ by -1.17 plus or minus 0.10 compared with improvement of -0.72 plus or minus 0.10 with placebo (p = 0.002). The frequency of treatment-related AEs was low and comparable between treatment groups, and the placebo-adjusted epistaxis rate for CIC was 1.8%.

Conclusions: Ciclesonide administered intranasally was superior to placebo in relieving nasal symptoms in adult and adolescent patients with SAR. Ciclesonide was well tolerated, with a safety profile comparable with placebo and a low epistaxis rate. These data support the continued clinical development of CIC nasal spray.

CONTACT: Dave Schemelia of HealthSTAR Public Relations, +1-609-468-9325,dschemelia@healthstarpr.com, for Sylvana Research