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Auxilium Pharmaceuticals, Inc.
Announces Initiation of XIAFLEX(TM) Phase IIb Study for Peyronie's
Disease
MALVERN, PA, Sep 17, 2008 (MARKET WIRE via COMTEX News Network)
-- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty
biopharmaceutical company, today announced that the first patients have
been dosed in the Company's U.S. phase IIb trial of XIAFLEX(TM) for the
treatment of Peyronie's disease. Peyronie's disease is the development
of a collagen plaque, or scar tissue, on the shaft of the penis that
hardens and reduces flexibility, causing the penis to bend or arc during
erection resulting in psychological distress and pain for the patient
and often interfering with or preventing intercourse.
"We believe XIAFLEX is a company-transforming product for
Auxilium and the excitement surrounding this trial in the urological
community that treats Peyronie's patients has been resounding.
Additionally, the response from potential patients has been highly
encouraging, and as a result, we believe we will complete enrollment in
this study in the first quarter of 2009," said Armando Anido, Chief
Executive Officer and President of Auxilium. "We are extremely pleased
to achieve this important development milestone in Peyronie's disease, a
potential second indication for XIAFLEX, and we look forward to having
the results of the trial by the end of 2009."
The Phase IIb study is a randomized, double-blind,
placebo-controlled study that is designed to assess the safety and
efficacy of XIAFLEX, when administered two times a week every six weeks
for up to three treatment cycles (2 x 3), in subjects with Peyronie's
disease. The study will involve at least 120 patients at approximately
11 sites throughout the U.S., and patients will be monitored for 36
weeks following the first injection.
The trial is also designed to validate a proprietary Peyronie's
Patient Reported Outcome (PRO) questionnaire, which will measure several
domains of patients' sexual quality of life, over a 36 week period. The
four domains measured by the PRO are penile pain, Peyronie's disease
bother, intercourse discomfort and intercourse constraint.
"We are encouraged by earlier Phase II clinical trials in
Peyronie's disease which demonstrated a reduction in penile curvature
with XIAFLEX," said Dr. Tony DelConte, Auxilium's Chief Medical Officer.
"Our team, in conjunction with outside experts, has spent a significant
amount of time and effort to develop the Peyronie's PRO questionnaire
and we are eager to validate its use for our Phase III protocols where
it is intended to be the primary endpoint."
To qualify for the study, patients must be able to maintain a
rigid erection and have a penile contracture between 30 and 90 degrees.
Patients will be stratified by the degree of penile curvature (i.e. 30
degrees to 60 degrees versus > 60 degrees) and then randomized into 4
treatment groups to receive either XIAFLEX or placebo with or without
modeling of the penile plaque. Modeling refers to massaging of the
plaque after the second injection of a treatment series and is intended
to maximize the enzymatic effect of the XIAFLEX injection in the plaque.
Patients will be randomized in a 3:1 ratio of XIAFLEX to placebo and a
1:1 ratio to receive penile plaque modeling or no modeling.
| Arm |
Study Drug |
Plaque
Modeling |
Targeted Number
of Patients |
|
================================================ |
| A |
XIAFLEX |
yes |
45 |
| B |
Placebo |
yes |
15 |
| C |
XIAFLEX |
no |
45 |
| D |
Placebo |
no |
15 |
|
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About Peyronie's Disease
Peyronie's disease is the development of collagen plaque, or
scar tissue, on the shaft of the penis that hardens and reduces
flexibility, thus causing pain and forcing the penis to bend or
arc during erection. This often can prevent intercourse. In
addition to difficulty with sexual intercourse, Peyronie's
disease may also be associated with emotional distress, loss of
self-esteem and depression. In certain populations, the
estimated number of men affected by Peyronie's Disease may be as
high as 9 percent in men over 60 years of age and 3 percent in
men over 30.(1)
(1) L.A. Levine "Peyronie's Disease: A Guide to Clinical
Management." Humana Press: 10-17, 2007.
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical
company with a focus on developing and marketing to urologists,
endocrinologists, orthopedists and select primary care
physicians. Auxilium markets Testim(R) 1%, a topical
testosterone gel, for the treatment of hypogonadism through its
approximately 190-person sales and marketing team. Auxilium has
five projects in clinical development. XIAFLEX(TM) (clostridial
collagenase for injection), formerly referred to as AA4500, is
in phase III of development for the treatment of Dupuytren's
contracture and is in phase II of development for the treatment
of Peyronie's disease and Frozen Shoulder syndrome (Adhesive
Capsulitis). Auxilium's transmucosal film product candidate for
the treatment of overactive bladder (AA4010) is in phase I of
development. The Company is currently seeking a partner to
further develop this product candidate. Auxilium also has one
pain product using its transmucosal film delivery system in
phase I of development. Auxilium has rights to seven additional
pain products and products for hormone replacement and urologic
disease using its transmucosal film delivery system. Auxilium
also has options to all indications using XIAFLEX for
non-topical formulations. For additional information, visit
http://www.auxilium.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION
REFORM ACT OF 1995
This release contains "forward-looking-statements" within the
meaning of The Private Securities Litigation Reform Act of 1995,
including statements regarding XIAFLEX as a company-transforming
product; the timing of completion of enrollment of patients in
the phase IIb trial for XIAFLEX for the treatment of Peyronie's
disease; the timing of release of results from the phase IIb
trial for XIAFLEX for the treatment of Peyronie's disease; the
ability to use data from the phase IIb study to further validate
the Patient Reported Outcome questionnaire as a tool to be used
as the primary efficacy endpoint in phase III studies for
XIAFLEX for the treatment of Peyronie's disease; the
interpretation of data from earlier phase II clinical trials for
Peyronie's disease; the number of men affected by Peyronie's
disease; and products in development for Dupuytren's
contracture, Frozen Shoulder syndrome, overactive bladder, pain,
hormone replacement and urologic disease. All statements other
than statements of historical facts contained in this release,
including but not limited to, statements regarding future
expectations, plans and prospects for the Company, statements
regarding forward-looking financial information and other
statements containing the words "believe," "appears," "may,"
"could," "will," "estimate," "continue," "anticipate," "intend,"
"should," "plan," "expect," and similar expressions, as they
relate to the Company, constitute forward-looking statements.
Actual results may differ materially from those reflected in
these forward-looking statements due to various factors,
including further evaluation of clinical data, results of
clinical trials, the performance of third-party service
providers, decisions by regulatory authorities regarding whether
or when to proceed to the next phase of clinical trials, general
financial, economic, regulatory and political conditions
affecting the biotechnology and pharmaceutical industries and
those discussed in the Company's Annual Report on Form 10-K for
the year ended December 31, 2007 under the heading "Risk
Factors", which is on file with the Securities and Exchange
Commission (the "SEC") and may be accessed electronically by
means of the SEC's home page on the Internet at
http://www.sec.gov or by means of the Company's home page on the
Internet at http://www.auxilium.com under the heading "Investor
Relations -- SEC Filings." There may be additional risks that
the Company does not presently know or that the Company
currently believes are immaterial which could also cause actual
results to differ from those contained in forward-looking
statements. Given these risks and uncertainties, any or all of
the forward-looking statements contained in this release may
prove to be incorrect. Therefore, you should not rely on any
such factors or forward-looking statements.
In addition, forward-looking statements provide the Company's
expectations, plans or forecasts of future events and views as
of the date of this release. The Company anticipates that
subsequent events and developments will cause the Company's
assessments to change. However, while the Company may elect to
update these forward-looking statements at some point in the
future, the Company specifically disclaims any obligation to do
so. These forward-looking statements should not be relied upon
as representing the Company's assessments as of any date
subsequent to the date of this release.
For More Information, Contact:
James E. Fickenscher
CFO
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
William Q. Sargent Jr.
VP IRbr> Auxilium Pharmaceuticals, Inc.
(484) 321-5900
SOURCE: Auxilium Pharmaceuticals, Inc
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