Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) today announced that its
Phase 3 clinical trial evaluating the Company’s
exclusively-licensed technology from the Mayo Clinic consisting of an
intranasal antifungal lavage, SinuNase™
(topical amphotericin B 0.01% suspension) achieved, as anticipated,
superior resolution of the cardinal symptoms of chronic sinusitis (CS),
as compared to placebo control arm, however, the analysis of the
unblinded primary endpoint data did not show the required level of
statistical significance when comparing the SinuNase arm to the control
arm. The unblinded intent-to-treat (ITT) statistical analysis using the O’Brien
composite ranking showed a p-value = 0.14 comparing SinuNase lavage to
the control lavage. The Company continues to believe that SinuNase is a
viable product candidate for the treatment of CS, and a full data
analysis of both the primary and secondary endpoints will be conducted
in order to determine the next steps necessary in order to advance the
product, both in its lavage and pump-spray formulations.
The safety profile of SinuNase lavage was comparable to the safety
profile of the control lavage without a single serious adverse event
attributable to SinuNase or any example of allergic reaction to SinuNase
despite over 20,000 dose exposures. The Company believes that the
results of this comparative lavage study are encouraging and support
that CS is due to a fungal-induced inflammation. The results for the
primary endpoint show a superiority of SinuNase lavage over control
lavage. Moreover, all of the patients enrolled in the study had their
nasal mucus test positive for eMBP (eosinophilic major basic protein
positive). Of the 299 enrolled, 299 tested positive for eMBP, strongly
supporting the role of eosinophilic reaction to fungi in the
pathogenesis of CS. In order to conduct a Phase 3 trial on the SinuNase
lavage, the Company had to perform a placebo-controlled double-blind
study, and accordingly, the control group had to be treated with a
lavage with the same volume of irrigant and method of delivery as the
treatment arm. The Company is not aware of any prior study of lavage,
including saline lavage, in well-documented CS cases that has
demonstrated significant symptom resolution, reduction in polyposis,
and/or improvement in CT scan of the sinuses. The Company notes that the
blinded ITT analysis on all enrolled patients remained consistent with
its previous reports. Based on the initial unblinded clinical trial
data, it appears that the control lavage unexpectedly achieved some
therapeutic effect (as opposed to a simple placebo effect). Accordingly,
it is our current belief that lavage alone may have reduced the fungal
load sufficiently enough to reduce the fungal-induced inflammation in
some patients and this may have masked somewhat the comparative benefits
of intranasal antifungal administration (SinuNase) as it relates to the
primary endpoint. The Company expects to have the full data set in
April, and believes it is possible that this data may provide additional
evidence among responders for superiority of intranasal antifungal
lavage compared to the control lavage in terms of lessening of severity
of symptoms in CS (i.e. improvement in a variety of symptoms as opposed
to resolution of just two cardinal symptoms), reduction in polyposis by
endoscopy, reduction in sinus inflammation by CT scan, and more
substantial reduction in molecular markers of fungus and inflammation in
the nasal mucus. As planned, the Company intends to meet with the FDA
soon after receiving the full data report in order to review the
outcomes. The full data set may also help to predict if a low volume
pump spray of SinuNase is likely to show superiority to placebo control
by eliminating any therapeutic benefits which appear to be intrinsically
associated with a lavage. The daily volumetric difference between the
lavage and pump spray is about an 80:1 ratio (i.e. 80 cc/day lavage vs
1cc/day pump spray). As previously announced, the Company has already
commenced preparations for a pump spray study because the pump is a more
user-friendly application than the lavage. Background
on CS CS is a debilitating disease with common symptoms
including severe nasal congestion, sinus headache, production of thick
mucus, runny nose, loss of smell, and chronic inflammation leading to
polyps, which are small growth in the nasal passages that hinder
breathing. CS can also result in opportunistic bacterial infections,
acutely exacerbating those symptoms and often bringing patients to
medical attention for the first time. Researchers at Mayo Clinic were
the first to propose that airborne fungus lodged in the mucus lining of
the sinuses was the root cause of CS. Since 1999, a comprehensive body
of basic and clinical research performed at the Mayo Clinic has
indicated that CS is an immune reaction caused by fungus in susceptible
patients (approximately 10% of the population), but as with most
revolutionary paradigm shifts in medicine, this unexpected etiology of a
host-determined reaction to a ubiquitous mold has been greeted with
significant skepticism. Dr. O’Donnell will
further discuss the top-line SinuNase Phase 3 study results on a
conference call and webcast, which will take place at 5:00 p.m. (EDT)
today. Anyone interested in participating on the conference call should
dial 1-877-407-9205 if calling within the United States or
1-201-689-8054 if calling internationally. Participants should ask for “Accentia’s
SinuNase Phase 3 Results” conference call.
There will be a playback available until April 7, 2008. To listen to the
playback, please call 1-877-660-6853 if calling within the United States
or 1-201-612-7415 if calling internationally. Please use Account# 286
and Conference ID# 278582 for replay. The call is also being webcast by
Vcall and can be accessed at Accentia’s
website at http://www.accentia.net
and at http://www.investorcalendar.com.
To access the webcast, you will need to have the Windows Media Player or
Real Player on your desk top. About
Accentia Biopharmaceuticals, Inc. Accentia
Biopharmaceuticals, Inc. is a portfolio company of the Hopkins Capital
Group, LLC. It is organized as 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, which
typically have a higher risk profile. The Company’s
lead product candidate is SinuNase™, 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 with an initial indication
targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune
is based on pulsed, ultra-high dosing of a well-known chemotherapeutic
agent under a risk management program. Additionally, through an
investment strategy, the Company has acquired the majority ownership
interest in Biovest International, Inc. (OTCBB:BVTI) and a royalty
interest in Biovest’s lead drug candidate,
BiovaxID® 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 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, please visit: http://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™,
SinuNase™, BiovaxID®,
AutovaxID™, SinuTest™,
AllerNase™ 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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