Accentia Biopharmaceuticals, Inc. Updates Results of Nationwide Testing with CRSFungal Profile: The First Diagnostic Test Available for the Confirmation of Chronic Sinusitis.
TAMPA, Fla. -- Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI; "Accentia") reports the results of CRSFungal Profile[TM], a patented, non-invasive diagnostic for Chronic Sinusitis (CS), otherwise known as Chronic Rhinosinusitis (CRS). CRSFungal Profile is the first laboratory diagnostic available for the estimated 31 million Americans that suffer from the debilitating disease. In partnership with the licensee for the technology, IMMCO Diagnostics Inc. (IMMCO) of Buffalo, NY, Accentia has made CRSFungal Profile available to ear, nose and throat (ENT) specialists and allergists nationwide.
To date, samples from 2,196 non-selected patients from practices throughout the U.S. have been tested using CRSFungal Profile, and 70% of those patients tested positive for the presence of fungal-induced inflammation, confirming the diagnosis of CS. CRSFungal Profile tests for the specific protein marker, eosinophil Major Basic Protein (eMBP), which is uniquely detectable in the mucus of patients with CS. The test uses a small sample of mucus from the patient's nose, which is then sent to IMMCO for an immunoassay analysis.
CS is one of the most common chronic diseases suffered by Americans today, affecting an estimated 31 million patients in the U.S. CS is a chronic inflammatory disease of the nasal and sinus mucosa that persists for greater than three months. Historically, the diagnosis of CS has been made based on a doctor's subjective assessment of a combination of the patient's symptoms, nasal endoscopy, and CT scan of the sinuses. There has been no confirmatory laboratory diagnostic test for the disease until the development and release of CRSFungal Profile.
Accentia Biopharmaceuticals is commercializing the diagnostic and developing a treatment for CS based on published technology discovered at the Mayo Clinic. Investigators at Mayo discovered that a ubiquitous, normally innocuous mold, Alternaria, colonizes the mucus of the nose and sinus of virtually everybody, but in patients with CS, this non-invasive mold elicits an eosinophilic inflammatory response characterized by release of eosinophil major basic protein (eMBP) in the mucus, which then damages the mucosal epithelial lining of the nose and sinuses and leads to the inflammatory mucosal changes characteristic of CS.
"Chronic sinusitis is extremely debilitating to the millions of sufferers worldwide. The improvements in diagnostic testing will make it easier for the practitioner to appropriately treat these patients," said Dr. David Sherris, Professor and Chairman, Department of Otolaryngology, University at Buffalo. "In clinical studies, patients with chronic sinusitis were positive for eMBP in their mucus, but it was not detected in patients with allergic rhinitis or in normal patients. With these updated results using CRSFungal Profile, we now have data on over 2,000 non-selected patients that eMBP is detectable in 70% of patients, suggesting that clinicians' suspicion of chronic sinusitis was correct in those patients."
Accentia is currently conducting a pivotal Fast Tracked Phase 3 study of a very low dose intranasal lavage formulation of an antifungal, Amphotericin B (SinuNase(TM)), for the treatment of the signs and symptoms of CS. The initial study population is in refractory patients who have undergone sinus surgery for CS but who are now struggling with recurrent CS. The 4-month randomized, double-blind, placebo-controlled clinical trial is designed to test the efficacy and safety of this particular intranasal antifungal for this indication.
To obtain the CRSFungal Profile sample collection kit or receive additional information, Accentia and IMMCO have the following toll free numbers available: Accentia 888-423-1046 or IMMCO 800-537-8378.
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., (OTCBB: BVTI), is currently in a Fast-Tracked Phase 3 clinical trial. Through Biovest, the Company also manufactures AutovaxID[TM], an FDA approved commercial-stage automated cell-manufacturing device that enables the cost-effective and scalable production of proteins and other cell-based products. Accentia is also proposing to enter a Phase 3 clinical trial 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 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 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 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.