Message #18 From:
NewsBot Date: November 9, 2006 05:00:00 AM
ABPI News Report Shows Use of a SinuNase Formulation is Associated With a Significant, 74% Reduction in Reoperations for Chronic Sinusitis Patients Who Are Refractory to Sinus Surgery
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals (NASDAQ: ABPI)
has announced that in a study of chronic sinusitis (CS) patients
refractory to sinus surgery, treated with various strengths of
extemporaneously prepared pump-spray formulations of intranasal
amphotericin B, a formulation containing a mid-range concentration of
amphotericin B was associated with a significant, 74% reduction in
repeat sinus surgery (P=0.01) when given over a one-year period of
continued usage. The retrospective study from a surgical practice was
updated and presented in a poster session at the recent 2006 American
Academy of Otolanyngology-Head and Neck Surgery Foundation meeting in
Toronto.
In addition to Accentia’s Phase 3 clinical
trial that commences this month for a lavage formulation of SinuNase™
(intranasal amphotericin B 0.01% suspension) for severe refractory
chronic sinusitis, the Company believes that a pump-spray formulation
containing a higher concentration of amphotercin B than the lavage
formulation of SinuNase may be an appropriate initial therapy for
patients with moderate CS, or as maintenance therapy for those patients
with severe CS who have responded to the lavage formulation of SinuNase.
Based on a national survey of ENTs and Allergists conducted this summer
and which will be presented by Accentia this weekend at the American
College of Allergy Asthma and Immunology, an estimated 25% of all
patients with chronic sinusitis seen by specialists are refractory to
surgery. There are approximately 31 million patients in the USA with
chronic sinusitis, for which there is currently no prescription
pharmaceutical available.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused
on the development of late-stage “disruptive”
clinical products. Accentia has a portfolio of currently marketed
respiratory products and a pipeline of products in clinical development.
The company’s lead respiratory product
candidate is SinuNase™, 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 we will
commence Phase III trials soon. The Company’s
other lead product is BiovaxID™, 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 III clinical trial. Additionally, the Company has a family of
respiratory specialty pharmaceutical products, including MDTurbo™,
an FDA approved, commercially available product that transforms over 90%
of dispensed metered-dose inhalers into a breath-activated,
dose-counting inhaler. For further information, please visit 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 SinuNase™,
BiovaxID™, AutovaxID™
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.
