BioSpecifics Technologies Corp. Announces Initiation of Phase 2a Study of
XIAFLEX for Treatment of Cellulite
- First patient dosed in Phase 2a randomized, double-blind multiple-dose study
LYNBROOK, N.Y., Oct. 23, 2013
LYNBROOK, N.Y., Oct. 23, 2013 /PRNewswire/ -- BioSpecifics Technologies Corp.
(NASDAQ: BSTC), a biopharmaceutical company developing first in class
collagenase-based products marketed as XIAFLEX^® in the U.S. and XIAPEX^® in
the EU, today announced that its partner Auxilium Pharmaceuticals, Inc.
(Auxilium) has dosed the first patient in its Phase 2a study of XIAFLEX
("collagenase clostridium histolyticum" or "CCH") for the treatment of
cellulite (edematous fibrosclerotic panniculopathy). Topline results from the
study are expected in the first quarter of 2015.
"We are pleased to report the clinical progress being made for this condition
which affects 85-98% of post-pubertal females and with no FDA approved
treatment options," commented Thomas L. Wegman, President of BioSpecifics. "We
have long believed in the vast potential of XIAFLEX as a treatment for many
indications caused by collagen accumulation and look forward to reporting
top-line data from this trial in the first quarter of 2015 as well as
reporting more near-term milestones including the upcoming PDUFA date for
XIAFLEX in Peyronie's disease which is December 6, 2013."
As reported by Auxilium this morning, the Phase 2a study is a randomized,
double-blind multiple-dose study expected to enroll approximately 144 women
between the ages of 18 and 45 in the U.S. Patients will be evaluated for
treatment efficacy by investigator and patient assessments, as well as 3-D
photographic imaging techniques. The study will be conducted in two stages and
safety will be evaluated through the collection of adverse events. If the
safety and local tolerability profile from the first stage has been found to
be acceptable, subjects will be enrolled in stage 2.
To qualify for the study, participants must have cellulite in the
posterolateral thighs and/or buttocks for at least 12 months prior to a
screening visit. Eligible study participants will be assigned to one of four
groups that vary in treatment dose (low, medium, high, and placebo and will be
randomized to low-dose XIAFLEX, mid-dose XIAFLEX, high-dose XIAFLEX, or
placebo in a 5:5:5:3 ratio. Total treatment doses per treatment session
include doses both lower and higher than the dose used in Dupuytren's
contracture with a palpable cord. Each subject may receive up to three
treatment sessions of study drug according to randomization and each treatment
session will be approximately 21 days apart. In this study, only the dimples
treated on Day 1 may be retreated on Day 22 (Treatment Session 2) and Day 43
(Treatment Session 3) if, in the opinion of the investigator, the dimple
continues to be evident. A variable number of dimples may be treated within
one treatment quadrant.
There are currently no FDA approved pharmaceutical therapies indicated for
cellulite. XIAFLEX treatment is intended to target and lyse, or break, those
collagen tethers that cause the skin dimpling associated with cellulite with
the goal of releasing the dimpling and potentially resulting in smoothing of
Edematous fibrosclerotic panniculopathy, commonly known as cellulite describes
a condition in which lobules of subcutaneous adipose tissue extend into the
dermal layer. Cellulite can involve the loss of elasticity or shrinking of
collagen cords, called septae, that attach the skin to lower layers of muscle.
When fat in cellulite prone areas swells and expands, the septae tether the
skin, which causes surface dimpling characteristic of cellulite. These changes
can visibly affect the shape of the epidermis and resemble an orange peel-like
dimpling of the skin.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has
developed injectable collagenase for twelve clinical indications to date.
Injectable collagenase is currently marketed as XIAFLEX^® (collagenase
clostridium histolyticum (CCH)) in the U.S. for the treatment of adult
Dupuytren's contracture patients with a palpable cord in the palm by
BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium) and marketed
in Europe and approved in Canada. Swedish Orphan Biovitrum AB has marketing
rights for XIAPEX^® (the EU tradename for CCH) for the treatment of
Dupuytren's contracture and Peyronie's disease in 71 Eurasian and African
countries. Asahi Kasei Pharma Corporation has development and
commercialization rights for XIAFLEX for the treatment of Dupuytren's
contracture and Peyronie's disease in Japan and Actelion Pharmaceuticals Ltd.
has development and commercialization rights for XIAFLEX for these two
indications in Canada, Mexico, Brazil and Australia. CCH is in clinical
development for the treatment of several additional promising indications.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set an action
date for XIAFLEX for Peyronie's disease of December 6, 2013.Auxilium is
testing CCH for frozen shoulder syndrome and cellulite. A Phase IIa trial of
CCH for cellulite was initiated in the fourth quarter of 2013 and Auxilium
expects to initiate next stage trials of CCH for frozen shoulder syndrome in
the same period. BioSpecifics is currently managing the development of CCH for
the treatment of human and canine lipomas, both of which are in Phase II
trials, and expects to report top-line data from these trials by the end of
2013. For more information, please visit www.biospecifics.com.
This release includes "forward-looking statements" within the meaning of, and
made pursuant to the safe harbor provisions of, the Private Securities
Litigation Reform Act of 1995. All statements other than statements of
historical fact are "forward-looking statements". The forward-looking
statements include statements concerning, among other things, the timing of
the release of data from the phase II trial of CCH as a treatment for
cellulite and the potential of CCH for the treatment of cellulite. In some
cases, you can identify these statements by forward-looking words such as
"believe," "expect," "anticipate," "plan," "estimate," "likely," "may,"
"will," "could," "continue," "project," "predict," "goal," the negative or
plural of these words, and other similar expressions. These forward-looking
statements are our predictions based on our current expectations and our
projections about future events. There are a number of important factors that
could cause our actual results to differ materially from those indicated by
such forward-looking statements, including the ability of Auxilium and its
partners to achieve their respective objectives for XIAFLEX in their
applicable territories; the uncertainties inherent in the initiation of future
clinical trials; Auxilium or any of its partners modifying their respective
objectives and/or allocating resources other than to XIAFLEX; the potential
market for XIAFLEX in a given indication being smaller than anticipated; the
potential of XIAFLEX to be used in additional indications and the initiation,
timing and outcome of clinical trials of XIAFLEX for additional indications;
the timing of regulatory filings and action; the receipt of any applicable
milestone payments from Auxilium; and other risk factors identified in our
Annual Report on Form 10-K for the year ended December 31, 2012, our Quarterly
Reports on Form 10-Q for the quarters ended March 31, 2013 and June 30, 2013,
and our Current Reports on Form 8-K filed with the SEC. All forward-looking
statements included in this release are made as of the date hereof, and we
assume no obligation to update these forward-looking statements.
SOURCE BioSpecifics Technologies Corp.
Contact: BioSpecifics Technologies Corp., Thomas L. Wegman, President, (516)
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