Data in the SinuNase Phase 3 Clinical Trial Predicts That Virtually 100% of Chronic Sinusitis Cases Are Due to a Fungal-Induced Inflammation.Results Identify a Market Potential of Over 60 Million Patients in the U.S. and EU for SinuNase TAMPA, Fla. -- Accentia Biopharmaceuticals (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ABPI ABPI Association of the British Pharmaceutical Industry ABPI Associação Brasileira da Propriedade Intelectual (Brazilian Intellectual Property Association; Brazil) ABPI Ankle Brachial Pressure Index ) announces evidence that most, if not all cases of chronic sinusitis chronic sinusitis Chronic sinus infection ENT Inflammation of the sinuses that empty into the nasal cavity Etiology Allergic rhinitis, nasal obstruction, deviated nasal septum, tooth abscesses, URIs (CS), are due to a fungal-induced inflammation as originally proposed by investigators at the Mayo Clinic. The data were collected as part of the Company's ongoing pivotal Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. for its lead pharmaceutical product, SinuNase[TM], an intranasal in·tra·na·sal adj. Within the nose. formulation of the antifungal amphotericin B amphotericin B (ăm'fətĕr`ĭsĭn), antibiotic that halts the growth of several disease-causing fungi. Discovered in 1956, it is produced by bacteria of the genus Streptomyces. 0.01% suspension. In order to be enrolled in the clinical trial, patients must have had well-documented CS based on a history of the requisite symptoms, nasal endoscopy nasal endoscopy Rhinolaryngoscopy, rhinopharyngoscopy, rhinoscopy The use of a flexible fiberoptic endoscope to evaluate upper airways–nasal passages, nasopharynx, oropharynx, and larynx, a procedure usually carried out by ENTs or allergists Indications findings, and CT scan CT scan: see CAT scan. See CAT scan. demonstrating characteristic mucosal changes in the sinuses. At the time of enrollment, all patients have had nasal mucin mucin: see glycoprotein. collected. Subsequently, these specimens are being tested for eosinophilic eosinophilic /eo·sin·o·phil·ic/ (-fil´ik) 1. readily stainable with eosin. 2. pertaining to eosinophils. 3. pertaining to or characterized by eosinophilia. major basic protein (eMBP). In the first fifty specimens now analyzed, all have been positive for eMBP, a toxic protein released by inflammatory cells in response to fungi. The Company believes that these findings strongly support a fungal-induced inflammation as the cause of CS. SinuTest[TM], the diagnostic used to measure eMBP in the nasal mucin, is a patented technology developed at the Mayo Foundation for Medical Education and Research. The technology is exclusively licensed to IMMCO Diagnostics, which has an exclusive commercialization agreement with Accentia Biopharmaceuticals. The Company believes that SinuTest will be a useful adjunct for identification of patients who are suspected of having CS and who may be candidates for treatment with SinuNase, assuming FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval. As previously announced, Accentia has received Fast Track status from the Food and Drug Administration (FDA) for SinuNase, and it is conducting a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled Phase 3 clinical trial with severe CS patients at more than 50 sites across the U.S. To the knowledge of the Company, this is the first and only Phase 3 clinical trial for CS and the only intranasal antifungal that has been submitted to the FDA as an Investigative New Drug (IND). The initial study population is with patients that have severe CS who have undergone sinus surgery, but who are struggling with recurrent CS. Despite the fact that there are over 60 million patients in the U.S. and EU that have CS, and that CS is by far the most common chronic respiratory disease with a commercial market approximately twice the size of asthma, there is currently no approved prescription pharmaceutical available for treatment of the disease. If approved, SinuNase will be the first therapy available to treat sufferers of CS. Accentia Biopharmaceuticals is commercializing SinuTest for the confirmation of CS. Investigators at Mayo discovered that a ubiquitous, normally innocuous mold, Alternaria Alternaria a saprophytic fungus commonly found on the skin; also has been associated with subcutaneous infections (phaeohyphomycosis) and reputed to be one of the causes of the indeterminate syndrome of forage poisoning in farm animals. Tenuazonic acid is a toxic metabolite. , colonizes in the mucus of the nose and sinus of virtually everybody. However, it was found that in patients with CS, this non-invasive mold elicits an eosinophilic inflammatory response characterized by the release of eMBP in the mucus, which then damages the mucosal epithelial lining of the nose and sinuses, leading to the inflammatory mucosal changes characteristic of CS. The SinuTest diagnostic uses a small sample of mucus from the patient's nose and tests for eMBP, which is uniquely detectable in the nasal mucin of patients with CS. About Accentia Biopharmaceuticals Accentia Biopharmaceuticals, Inc. and its subsidiaries (collectively referred to as the "Company" or "Accentia") is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase(TM), a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune, to treat numerous autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V, under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. ("Biovest"), (BVTI.OB) and a royalty interest royalty interest The proportional ownership interest by the owner of oil and gas rights in income produced by the asset. See also overriding royalty interest. in Biovest's lead drug candidate, BiovaxID(TM) and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular fol·lic·u·lar adj. 1. Relating to, having, or resembling a follicle or follicles. 2. Affecting or growing out of a follicle or follicles. non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma . BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry. For further information, visit the Company Web site at www.accentia.net. Forward-Looking Statements 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 Revimmune(TM) SinuNase(TM), BiovaxID(TM), AutovaxID(TM), CRSFungal Profile(TM) and any other statements relating to products, product candidates, product development programs the FDA or clinical study 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 Commission. 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. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners. |
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