LYNBROOK, N.Y., Nov. 17, 2016 /PRNewswire/ -- BioSpecifics
Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that
originated and continues to develop collagenase based-therapies
with a first in class collagenase-based product collagenase
clostridium histolyticum, or CCH, marketed as
XIAFLEX® in the U.S. and
Xiapex® in Europe today announced positive,
highly statistically significant results from a Phase 2b study of
CCH for the treatment of cellulite, or edematous fibrosclerotic
panniculopathy. Trial subjects receiving CCH showed statistically
significant levels of improvement in the appearance of cellulite
with treatment, as measured by the trial's primary endpoint
(p<0.001), compared to those subjects receiving placebo. CCH was
well-tolerated in the actively treated subjects with most adverse
events being mild to moderate in severity, and primarily limited to
the local injection area.
"Like in the prior Phase 2a study, these positive results are
very encouraging, particularly because both patients and physicians
saw a statistically significant improvement in the appearance of
cellulite after CCH treatment," said Thomas
L. Wegman, President of BioSpecifics. "Cellulite is highly
prevalent in women and we see a promising opportunity for CCH in
this indication and other cosmetic indications. We look forward to
our partner advancing development of CCH for cellulite into Phase
3."
The Phase 2b trial was conducted by BioSpecifics' partner Endo
International plc and enrolled 375 women with moderate or severe
cellulite aged 18 years or older in the
United States. Each subject received up to three treatment
sessions of CCH (0.84 mg / session) or placebo with each treatment
session occurring approximately 21 days apart. Twelve injections
were administered into cellulite dimples during each session across
an entire treatment quadrant - left or right buttock or left or
right posteriolateral thigh. At both the outset and conclusion of
the study period (28 days after the last treatment), cellulite
severity was assessed by each patient and clinician using two
photonumeric cellulite severity scales developed by Endo and
third-party experts. The scales - the Photonumeric Cellulite
Severity Scale (PCSS) - are 5-point scales ranging from 0 (no
cellulite) to 4 (severe cellulite) that measure improvement in the
appearance of cellulite.
The primary endpoint was the proportion of composite responders
at Day 71 defined as subjects with a 2-point improvement in
severity from baseline in the clinician-reported (CR) PCSS and a
2-point improvement in the patient-reported (PR) PCSS. Additional
endpoints include a composite of 1-point responders, the percentage
of responders with 1-point and 2-point improvements on the CR-PCSS
and PR-PCSS, assessment of improvement by patient and clinician
using the Global Aesthetic Improvement Scale (GAIS); subject
satisfaction, and change in the Hexsel cellulite severity
scale.
Key Phase 2b Trial Results Include:
- Subjects receiving CCH demonstrated a highly statistically
significant improvement in the primary endpoint of composite
investigators' and patients' assessments of the appearance of
cellulite, as measured by a two-point improvement in both the
CR-PCSS and PR-PCSS scores, with a p-value of <0.001 versus
placebo.
- Subjects receiving CCH demonstrated a highly statistically
significant improvement in the composite investigators' and
patients' assessments of the appearance of cellulite, as measured
by a one-point improvement in both the CR-PCSS and PR-PCSS scores,
with a p-value of <0.001 versus placebo.
- A highly significant proportion of CCH subjects reported being
"Satisfied" or "Very Satisfied" with their cellulite treatment,
compared to placebo subjects, with a p-value of <0.001.
- A highly significant proportion of CCH subjects were reported
as "Improved" or "Very Improved" or "Very Much Improved" in global
appearance of their cellulite area as assessed by the subjects and
investigators, compared to placebo subjects, with a p-value of
<0.001.
- CCH was well-tolerated by all dose groups with most adverse
events (AEs) being mild to moderate and primarily limited to the
local injection area; 92 percent of all related AEs were mild to
moderate in the CCH group compared to 96 percent in the placebo
group; the most common AEs were expected and included injection
site bruising (approximately 75 percent) and injection site pain
(approximately 59 percent).
About Cellulite
Edematous fibrosclerotic panniculopathy, commonly known as
cellulite, describes a condition in which lobules of subcutaneous
adipose tissue extend into the dermal layer. Cellulite affects
approximately 85-98 percent of post-pubertal females and 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 marketed as XIAFLEX®
in the U.S. for the treatment of Dupuytren's contracture and
Peyronie's disease by BioSpecifics' partner, Endo International plc
(Endo). XIAFLEX® is also commercialized
in Japan, Europe, Canada and Australia for
Dupuytren's contracture and also for Peyronie's disease
in Europe and Australia. Swedish Orphan Biovitrum AB
(Sobi) has marketing rights for Xiapex® (the European
tradename for XIAFLEX) in Europe
and certain Eurasian countries and Asahi Kasei Pharma Corporation
(Asahi) has marketing rights in Japan. Sobi is selling Xiapex
in Europe for the treatment of Dupuytren's contracture
and Peyronie's disease and Asahi is selling XIAFLEX for the
treatment of Dupuytren's contracture in Japan. The XIAFLEX
research and development pipeline includes several additional
promising indications. Endo is currently managing development of
CCH for Dupuytren's nodules, cellulite, adhesive capsulitis, human
and canine lipoma, lateral hip fat and plantar fibromatosis.
BioSpecifics is managing the development of CCH for uterine
fibroids and plans to initiate clinical development in the first
quarter of 2017. For more information, please
visit www.biospecifics.com.
Forward-Looking Statements
This press 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, including statements regarding the company's
strategy, future operations, future financial position, future
revenues, projected costs, prospects, plans and objectives of
management, expected revenue growth, and the assumptions underlying
or relating to such statements, are "forward-looking statements."
The forward-looking statements in this press release include
statements concerning, among other things, whether there is a
promising opportunity for CCH for the treatment of cellulite and
other cosmetic indications and whether and when Endo will advance
development of CCH for cellulite into Phase 3.In some cases, these
statements can be identified by forward-looking words such as
"believe," "expect," "plan", "may," "will," "can," and "could," the
negative or plural of these words, and other similar expressions.
These forward-looking statements are predictions based on
BioSpecifics' current expectations and its projections about future
events and various assumptions. There can be no assurance that
BioSpecifics will realize its expectations or that BioSpecifics'
beliefs will prove correct. There are a number of important factors
that could cause BioSpecifics' actual results to differ materially
from those indicated by such forward-looking statements, including
the timing of regulatory filings and action; the ability of Endo
and its partners, Asahi Kasei Pharma Corporation and Swedish Orphan
Biovitrum AB, to achieve their objectives for XIAFLEX in their
applicable territories; the market for XIAFLEX in, and timing,
initiation and outcome of clinical trials for, additional
indications including adhesive capsulitis, cellulite, human lipoma,
canine lipoma, uterine fibroids, plantar fibromatosis, lateral hip
fat and Dupuytren's nodules all of which will determine the amount
of milestone, royalty, mark-up on cost of goods sold, license and
sublicense income BioSpecifics may receive; the potential of CCH to
be used in additional indications; Endo modifying its objectives or
allocating resources other than to XIAFLEX; and other risk factors
identified in BioSpecifics' Annual Report on Form 10-K for the year
ended December 31, 2015, Quarterly
Reports on Form 10-Q for the quarters ended March 31, 2016, June 30,
2016 and September 30, 2016
and BioSpecifics' Current Reports on Form 8-K filed with the
Securities and Exchange Commission. All forward-looking statements
included in this press release are made as of the date hereof, are
expressly qualified in their entirety by the cautionary statements
included in this press release and, except as may be required by
law, BioSpecifics assumes no obligation to update these
forward-looking statements.
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SOURCE BioSpecifics Technologies Corp.