Accentia Biopharmaceuticals Announces Results on Primary Endpoint in Clinical Study of SinuNase Lavage
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(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(TM), 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(R) 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(TM), SinuNase(TM), BiovaxID(R), AutovaxID(TM), SinuTest(TM), AllerNase(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.
Contact
Accentia Biopharmaceuticals, Inc., Tampa
Corporate Contacts:
Douglas Calder, Director of Investor Relations &
Public Relations, 813-864-2554 ext. 258
dwcalder@accentia.net
or
Susan Bonitz, Ph.D., Director, Program Coordination
813-864-2554 ext. 277
sbonitz@accentia.net
Posted: March 2008
