LYNBROOK, N.Y., April 18, 2017 /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 marketed as
XIAFLEX® in the U.S. and
Xiapex® in Europe, today announced that it has
initiated an open-label, dose escalation Phase 1 clinical trial of
XIAFLEX for the treatment of uterine fibroids.
"The treatment of our first patient in this trial for uterine
fibroids is an important milestone for BioSpecifics and supports
our business objective to develop XIAFLEX for medically necessary
indications," commented Thomas L.
Wegman, President of BioSpecifics. "We believe there are
strong benefits to XIAFLEX as a potential non-surgical treatment
for uterine fibroid patients and that achieving a reduction in the
size and stiffness of the fibroids will decrease symptoms of pain
and bleeding, avoid the need for surgical procedures and result in
a better quality of life for affected women."
The Phase 1 open-label dose escalation study is being conducted
at the Department of Gynecology & Obstetrics at Johns Hopkins University and will enroll 15 female
subjects treated prior to hysterectomy. Three subjects have been
injected with saline only to evaluate the safety and effectiveness
of the injection method and the remaining 12 subjects will now be
injected with increasing doses of XIAFLEX. The primary endpoint
will assess the safety and tolerability of a single injection of
XIAFLEX directly into the uterine fibroids at three doses under
transvaginal ultrasound guidance. The secondary endpoints will
assess symptoms of pain and bleeding, quality of life throughout
the study, shrinkage of XIAFLEX treated fibroids in size, increased
rates of apoptosis in treated fibroids and a decrease in the
collagen content of treated fibroids.
About Uterine Fibroids
Uterine fibroids are very
common benign tumors in the reproductive tract that contain large
amounts of collagen which may cause pelvic discomfort and pain,
decreased fertility, pregnancy complications, an increased rate of
miscarriage, uterine bleeding, prolonged menstrual bleeding and
frequent urination. Uterine fibroids are the leading cause of
hysterectomies in the U.S., accounting for about 250,000
hysterectomies and 30,000 myomectomies performed each year. Uterine
fibroids have been estimated to cost up to $9.4
billion annually in direct costs in the U.S. and there is
a high level of recurrence with current treatment options.
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 for Peyronie's disease in Europe
and Australia. Endo is partnered with Sobi, Actelion and Asahi
Kasei for Dupuytren's contracture and Peyronie's disease outside
the U.S. The XIAFLEX research and development pipeline includes
several additional promising indications. BioSpecifics is managing
the development of XIAFLEX for uterine fibroids and is conducting a
Phase 1 clinical trial. 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
are strong benefits to XIAFLEX as a potential non-surgical
treatment for uterine fibroid patients and whether achieving a
reduction in the size and stiffness of the fibroids will decrease
symptoms of pain and bleeding, avoid the need for surgical
procedures and result in a better quality of life for affected
women. 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, Actelion Ltd. 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 that will
determine the amount of milestone, royalty, mark-up on cost of
goods sold, license and sublicense income BioSpecifics may receive;
the potential of XIAFLEX 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, 2016 and
its 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.