LYNBROOK, N.Y., Oct. 31, 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 positive topline data from its Phase 1 trial of
Collagenase Clostridium Histolyticum (CCH) for the treatment of
uterine fibroids. The study met the primary endpoint of safety and
tolerability with no observed clinically significant adverse
reactions. Pharmacodynamic changes were noted in all secondary
endpoints with the exception of apoptosis. Statistically
significant reductions in collagen content were observed as
compared to control fibroids with a median reduction of 39 percent
(p<0.05), as well as statistically significant reductions in
collagen distribution as compared to control fibroids with an
average reduction in density of collagen bundles of 21 percent.
"These topline data highlight the potential promise of this
non-surgical treatment option, to safely and effectively reduce the
collagen content of uterine fibroids, which are extremely prevalent
tumors of the female reproductive tract," said Thomas L. Wegman, President of BioSpecifics. "We
are excited to see the pharmacodynamic changes observed in situ in
the treated uterine fibroids and we look forward to presenting the
full data and subsequently progressing this program into Phase 2
studies. Uterine fibroids have very few non-surgical treatment
options and it is our hope to bring CCH to these patients in order
to not only treat their fibroids, but also improve their quality of
life."
"Non-invasive surgical options for uterine fibroid management
are extremely limited, but necessary for the thousands of patients
who deal with the symptoms of this common condition," said
Phyllis Leppert, M.D., Ph.D.,
Professor Emeritus of Obstetrics and Gynecology, Duke University, senior author of preclinical
studies of CCH for treatment of uterine fibroids. "The preliminary
safety and efficacy of CCH suggests that increased stiffness in the
extracellular matrix of fibroids is a crucial aspect of the disease
process. I look forward to seeing the Phase 1 data mature as CCH
for the treatment of uterine fibroids demonstrates a promising,
non-invasive treatment option for patients with uterine
fibroids."
Topline Results
12 subjects with uterine fibroids
were injected transvaginally under ultrasound guidance with CCH in
stepped increased dosages and three subjects with uterine fibroids
were injected with saline and methylene blue. Only one fibroid per
patient was treated with CCH injection. Treated and control tissue
samples were harvested at surgery from 24 hours to 60 days
following injection. The effects of the CCH injection on collagen
content and distribution of collagen bundles and apoptosis were
compared between the control arm and the injected fibroids.
Statistically significant reductions in collagen content as
compared to control fibroids were observed with a median reduction
of 39 percent (p <0.05). Treated fibroid samples had an average
21 percent reduction in density of collagen bundles compared to
control tissues. No increases in apoptosis in treated tissues
compared to control tissues were observed. CCH injections were safe
and well tolerated in all patients with no clinically significant
adverse events related to study drug reported. In patients who
reported pain at baseline, the pain decreased within 24 to 48 hours
and remained low until the last visit at 60 to 90 days.
BioSpecifics has submitted the full data to be presented at an
upcoming medical meeting.
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 Canada, Europe and Australia. The CCH
research and development pipeline includes several additional
promising indications, including Phase 3 clinical trials for the
treatment of cellulite with top-line data expected in the fourth
quarter of 2018. BioSpecifics is managing the development of CCH
for the treatment of uterine fibroids the Phase 1 clinical trial
with full data expected in the first quarter of 2019. For more
information, please visit www.biospecifics.com.
Forward-Looking Statements
This report 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 include statements concerning, among
other things, the potential promise of CCH for the treatment of
uterine fibroids to safely and effectively reduce the collagen
content of uterine fibroids, whether and when we will present the
full data and progress the CCH program into Phase 2 studies,
whether CCH will not only treat fibroids but also improve patients'
quality of life, as expected, and whether and when top-line data
will be released from the Phase 3 clinical trials for the treatment
of cellulite. In some cases, these statements can be identified by
forward-looking words such as "expect," "plan," "anticipate,"
"potential," "estimate," "can," "will," "continue," the negative or
plural of these words, and other similar expressions. These
forward-looking statements are predictions based on our current
expectations and our projections about future events and various
assumptions. There can be no assurance that we will realize our
expectations or that our 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, which will determine the amount of milestone, royalty,
mark-up on cost of goods sold, license and sublicense income that
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, 2017, Quarterly Reports
on Form 10-Q for the quarters ended March
31, 2018 and June 30, 2018 and
its Current Reports on Form 8-K filed with the Securities and
Exchange Commission. All forward-looking statements included in
this Report are made as of the date hereof, are expressly qualified
in their entirety by the cautionary statements included in this
Report and, except as may be required by law, we assume no
obligation to update these forward-looking statements.
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