The first poster, entitled "U.S. and European Perspective on the Burden of Chronic Sinusitis: Survey of Allergists and Otolaryngologists" by Katz, et al., provided results showing that respondents see and treat 45 adult CS patients on average (highest, 80 U.S.; lowest, 21 France) in a typical month, and that ENTs treat about two times more CS patients per month than do allergists, with about one-third (34%) of the patients being surgery refractory. Respondents were generally unhappy with current treatments (86%), wished for more options to treat the surgery refractory population (86%), and for a treatment proven safe and efficacious (91%). Across countries and specialties, respondents agreed that those patients with CS refractory to surgery, suffer from a severe and debilitating condition (88%).
The second poster, entitled "Fungal Etiology of Chronic Sinusitis: Knowledge and Attitudes Survey in the U.S. and Europe" by Stergiou, et al., provided results showing that 71.2% of U.S. and 63.8% of European physicians reported that strong evidence has recently been substantiated to support a fungal etiology to CS. Additionally, 74.9% of the U.S. and 75.4% of European physicians agreed that there was a fungal etiology to CS. The majority of U.S. respondents (83.6%) agreed that surgery refractory CS patients are one subpopulation where a fungal etiology is more likely while 7 0.4% of Europeans agreed with the statement. Nearly 74% of U.S. and 44% of European physicians believed that intranasal antifungals were appropriate for surgery refractory adult CS patients. Half of U.S. and one-quarter of European respondents prescribed intranasal antifungals, and of those who did so, nearly 50% used Amphotericin B.
The third poster, entitled "Differences in Treatment Practices of Chronic Sinusitis in Europe and U.S." by Casciano, et al., provided results showing that the majority of respondents reported that almost all of their patients get some pharmacotherapy, with most of those being treated with at least two agents. Half of U.S. and one-quarter of European respondents reported prescribing intranasal antifungals, with German physicians being more likely to do so than French or British respondents. Respondents mentioned they are looking for more options to treat surgery refractory CS patients and believe pharmacotherapies are a key treatment for this patient population. Overall, the most important attributes considered by physicians when selecting CS treatment are the product's efficacy for treating surgery refractory CS and low occurrence of side-effects.
Dr. Angelos Stergiou, Medical Director at Accentia Biopharmaceuticals, commented, "With few options for the millions suffering from surgery refractory chronic sinusitis, we are excited about the potential for intranasal antifungals to provide safe and effective relief. The growing acceptance of the fungal etiology of chronic sinusitis in these patients by the medical community represents a significant advance in the treatment of this burdensome condition. We are currently in a Phase 3 clinical trial for SinuNase(TM), which we expect will provide insight into the potential of the product to become the first approved treatment for chronic sinusitis. This is a serious and debilitating disease and we hope to effectively treat those patients in need."
Dr. Raymond Slavin, from t he Saint Louis University School of Medicine, said, "The potential identification of an etiology for chronic sinusitis, and the subsequent development of an effective pharmacotherapy, would represent an important advance in the treatment of patients suffering from surgery refractory chronic sinusitis. This is one of the most common chronic illnesses, affecting millions, and the potential of intranasal antifungals to significantly reduce morbidity is tremendous."
Accentia has received Fast Track status from the Food and Drug Administration for SinuNase, and has initiated a Phase 3 clinical trial at sites across the U.S., in patients with severe chronic sinusitis who have had one or more prior sinus surgeries. Patients who believe they may be eligible to participate in a clinical trial with SinuNase are encouraged to visit www.accentia.net/patients/trials_sinunase.php, or call 212-686-4100.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development of late-stage "disruptive" clinical products, especially for already-approved drugs in new formulations and/or new indications that are patent-protected and which represent new therapeutics with greater clinical and economic value. Accentia has a pipeline of products in late-stage clinical development. The company's lead respiratory product candidate is SinuNase(TM), which is under clinical development to treat chronic sinusitis (rhinosinusitis). SinuNase is a novel application and formulation of a known anti-fungal exclusively licensed from the Mayo Foundation for Medical Education and Research. The product has been Fast Tracked by the FDA and the Company has commenced a Phase 3 clinical trial. The Company's other lead product is BiovaxID(TM), a patient-specific anti-cancer vaccine for the treatment of follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia's subsidiary, Biovest International, Inc., (OTCB B: BVTI), is currently in a Fast-Tracked Phase 3 clinical trial. The Company is also proposing to enter Phase 3 clinical trials for Multiple Sclerosis using Revimmune(TM), which uses an approved drug in an exclusively licensed method of therapy to "reboot" a patient's immune system. Revimmune was developed at the Johns Hopkins School of Medicine for the elimination of autoimmunity, and Accentia has acquired the exclusive worldwide rights for all autoimmune diseases. For further information, please visit www.accentia.net.
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about SinuNase, BiovaxID, AutovaxID, Revimmune and any other statements relating to products, product candidates, product development programs the FDA or clinical trial process including the commencement, process or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange C ommission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Accentia Biopharmaceuticals, Inc., Tampa, FL
Susan Bonitz, PhD
813-864-2554 - Extension: 277
The Investor Relations Group, New York
Janet Vasquez or Lynn Granito