LYNBROOK, N.Y., March 12, 2018 /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 the
presentation of interim data from its ongoing Phase 1 trial of
Collagenase Clostridium Histolyticum (CCH) for the treatment of
uterine fibroids at the 65th Annual Scientific Meeting
of the Society for Reproductive Investigation on Friday, March 9, 2018 in San Diego, CA. The data show the safety and
effectiveness of the CCH injection method in five patients.
"These interim data are very encouraging and show not only a
significant reduction of collagen content but also the disruption
of the tissue pattern in the uterine fibroids injected with CCH,"
said Thomas L. Wegman, President of
BioSpecifics. "Although uterine fibroids are the most prevalent
tumor of the female reproductive tract, non-surgical treatments are
extremely limited and this is the first trial assessing the
treatment of uterine fibroids using injectable collagenase. We
believe there are strong benefits to a treatment that can
effectively reduce the size and stiffness of the fibroids which
will ultimately decrease symptoms of pain and bleeding, avoid the
need for surgical procedures and result in a better quality of life
for these affected women."
Three patients were injected with CCH and underwent a
hysterectomy 24-96 hours after the injection. Two patients
subsequently were injected with a higher dose of collagenase, and
underwent a hysterectomy 63 days after the injection. The
collagenase-treated tissue samples showed not only a significant
reduction of collagen content but also the disruption of the tissue
pattern, while in control tissues the collagen remained abundant
and compact. The digestion of collagen did not extend beyond the
capsule of any fibroid. No adverse event occurred in these
patients.
The Phase 1 open-label dose escalation study is being conducted
at the Department of Gynecology & Obstetrics at Johns Hopkins University and will enroll a total of
15 female subjects treated prior to hysterectomy. 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 thirteen 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. The CCH research and development pipeline
includes several additional promising indications. BioSpecifics is
managing the development of CCH 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, the progression of our
Phase 1 clinical trial of CCH for the treatment of uterine
fibroids; whether and when we will report data from our Phase 1
clinical trial of CCH for the treatment of uterine fibroids and
whether CCH treatment will result in strong benefits that can
reduce the size and stiffness of uterine fibroids, decrease
associated symptoms, avoid the need for surgical procedures and
result in 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, Quarterly Reports on Form 10-Q for
the quarters ended March 31, 2017, June 30, 2017 and
September 30, 2017 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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