Message #17 From:
Stock News Bot Date: November 6, 2006 05:05:00 AM
ABPI News Accentia Biopharmaceuticals Commences Fast-Tracked Phase 3 Clinical Trial of SinuNase for the Treatment of Chronic Sinusitis
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals (NASDAQ: ABPI)
will begin enrolling patients for its Phase 3 study of SinuNase™
in November and will include patients with severe chronic sinusitis
refractory to sinus surgery. The Company believes that SinuNase, which
has been Fast Tracked by the Food and Drug Administration (FDA), is the
first product candidate to be in a Phase 3 trial for chronic sinusitis.
Despite the fact that there are 31 million affected U.S. patients, and
that chronic sinusitis is by far the most common chronic respiratory
disease with a market twice the size of asthma, there is currently no
approved prescription pharmaceutical for chronic sinusitis.
More than 50 investigative sites have been identified. Over the last
several months, the sites have screened for candidates who likely meet
the inclusion criteria from their active patient files. A typical site
estimates that it has about 200 chronic sinusitis patients refractory to
surgery. The trial will be a 16-week, double-blinded comparison with 300
patients randomized between SinuNase (intranasal lavage of 0.01%
amphotericin B) and placebo, with the primary endpoint being the
resolution of the key cardinal symptoms of chronic sinusitis. Secondary
endpoints include endoscopy scores and sinus mucosal thickening on CT
scan.
More details about the SinuNase clinical trials will be presented by Dr.
Frank E. O’Donnell Jr., Chairman and Chief
Executive Officer, at the Rodman and Renshaw 8th
Annual Healthcare Conference on November 6, 2006, at 12:40 pm. The
presentation will be simultaneously webcast, and then archived for 90
days. To access a live audio webcast or the subsequent archived
recording, log on to http://www.wsw.com/webcast/rrshq10/abpi.
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.
