Angiotech announces preliminary data from pivotal European gynecology anti-adhesion study
12 November 2004 - 3:01PM
PR Newswire (US)
Angiotech announces preliminary data from pivotal European
gynecology anti-adhesion study VANCOUVER/SAN FRANCISCO, CA, Nov. 12
/PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) today announced preliminary
eight-week follow-up data on 20 patients from a single center in
its pivotal European study using Adhibit(TM) to reduce the
incidence and severity of adhesions following laparoscopic surgery
in a gynecological population. Data from this pivotal trial may be
used to support the European submission for consideration of CE
Mark approval and commercialization in Europe. The results were
announced today at the 33rd Annual Meeting of the American
Association of Gynecologic Laparoscopists in San Francisco, CA. The
study involves 75 patients in total - randomized 2:1, and was
initiated at four centers in Germany, Europe, and the Dutch
Antilles. It is designed to evaluate safety and efficacy of
Adhibit(TM) for the prevention of post-surgical adhesions (internal
scar) in patients undergoing laparoscopic surgical removal of
fibroids from the uterus (myomectomy). Both laparoscopic and
traditional open surgical approaches were permitted. Laparoscopic
myomectomy differs from conventional abdominal myomectomy in that
only a few keyhole incisions are used rather than one large
incision. The test group had Adhibit(TM) sprayed onto the surgical
sites, while the control group was left untreated. It is
hypothesized that Adhibit(TM) binds to tissue during the critical
period when adhesions typically form and by acting as a physical
barrier, thus prevents their occurrence. The endpoint of the trial
is to measure the extent and severity (dense vs. filmy) of the
adhesion formation by conducting a follow-up look with a
laparoscopy eight weeks after the initial procedure. There are
three types of adhesions: filmy, vascular, and dense. Dense
adhesions are considered both the most difficult to treat and
likely to recur, as well as the ones that traditionally cause
problems for the patient, such as more severe chronic pain, and
infertility. The interim results are from this single center
experience and suggest a favorable and major difference in the
change-in-baseline adhesion scores favoring the Adhibit(TM)-treated
group. The Adhibit(TM)-treated group totaled 14 patients with a
total of 210 inspected sites, while the control group totaled six
patients with a total of 90 inspected sites. These various
locations such as the uterine wall, abdominal wall, and adnexa
(fallopian tubes & ovaries) were inspected on the second look.
Highlights of the study include: - Presence of adhesions at only
13.8% of inspected sites in the Adhibit(TM)-treated group versus
46.7% of inspected sites in the control group, an over three-fold
improvement in the reduction of lesions. - Presence of adhesions at
only 10.7% of adnexal inspected sites in the Adhibit(TM)-treated
group versus 50.0% of adnexal inspected sites in the control group,
an almost 5-fold improvement in the reduction of lesions. Adnexa
are a critical location since adhesions in the delicate structures
of fallopian tubes and ovaries can often lead to fertility issues.
- Only 0.9% of total inspected sites in the Adhibit(TM)-treated
group had dense adhesions versus 23.3% of total inspected sites in
the control group. - 0% of adnexal inspected sites in the
Adhibit(TM)-treated group had dense adhesions versus 25.0% of
adnexal inspected sites in the control group. - Of the adhesions
experienced in Adhibit(TM)-treated group, only 6.8% were dense
while of the adhesions experienced in the control group, 47.6% were
dense. This suggests that even if the few patients who did
experience adhesions in the Adhibit(TM)-treated group had happen to
arise in the Adhibit(TM)-treated patient it has a 7-fold greater
chance of being a more benign type lesion than in the untreated
patient. Adhibit(TM) was found to be safe, with no adverse events
reported related to the use of the product. Additional clinical
studies are underway to evaluate further the adhesion prevention
properties of Adhibit(TM) in myomectomy and other gynecologic
laparoscopic surgeries. "These data from one center's experience
with Adhibit(TM) is very encouraging," said William Hunter,
President and CEO of Angiotech. "We look forward to ultimately
viewing the complete data which we hope advances Adhibit(TM) as a
useful and potent tool in the gynecologic space as a means of
reducing painful and damaging adhesions." Adhesions occur when
normally separate tissues scar together. At the time of surgery,
there is damage to tissue, which can lead to abnormal connections
between tissues and organs. Adhibit(TM) binds directly to the
tissue and forms a temporary barrier between surfaces, preventing
contact and adhesions from forming. Potential serious complications
of adhesions include conditions such as chronic pain, bowel
obstruction and infertility. It has been reported that there is a
90% incidence of adhesions in patients with multiple previous
surgeries and an over 70% incidence of adhesions in women with
previous gynecologic surgeries. Uterine fibroids are the most
common solid pelvic tumor in women, present in up to 70% of the
female population. In the U.S., 175,000-200,000 hysterectomies and
40,000 myomectomy procedures are performed each year due to uterine
fibroids. Adhibit(TM) has other distinguishing features; it is
easily applied with a spray system making it uniquely suitable for
effective endoscopic application, and only takes one minute to
prepare. The product is a completely synthetic, self-polymerizing
liquid hydrogel that is safely metabolized by the body in less than
30 days. Adhibit(TM) adhesion prevention gel is already approved in
Europe to prevent or reduce post-surgical adhesion formation in
pediatric patients undergoing cardiac surgery. Adhibit(TM) is a
trademark of Cohesion Technologies Inc, a wholly owned subsidiary
of Angiotech Pharmaceuticals, Inc. Adhibit(TM) is currently sold,
marketed and distributed by Baxter Healthcare Corporation, based on
a February 2003 worldwide (excluding Japan and certain other
territories) strategic alliance between Angiotech and Baxter.
Vancouver-based Angiotech Pharmaceuticals, Inc., a specialty
pharmaceutical company focusing on drug-coated medical devices and
biomaterials, is dedicated to enhancing the performance of medical
devices and biomaterials through the innovative uses of
pharmacotherapeutics. To find out more about Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please
visit our website at http://www.angiotech.com/. Statements
contained herein that are not based on historical or current fact,
including without limitation statements containing the words
"anticipates," "believes," "may," "continue," "estimate,"
"expects," and "will" and words of similar import, constitute
"forward-looking statements" within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the actual results, events or developments
to be materially different from any future results, events or
developments expressed or implied by such forward-looking
statements. Such factors include, among others, the following:
general economic and business conditions, both nationally and in
the regions in which the Company operates; technology changes;
competition; changes in business strategy or development plans; the
ability to attract and retain qualified personnel; existing
governmental regulations and changes in, or the failure to comply
with, governmental regulations; liability and other claims asserted
against the Company; and other factors referenced in the Company's
filings with the United States Securities and Exchange Commission
or the Canadian securities regulators. Given these uncertainties,
readers are cautioned not to place undue reliance on such
forward-looking statements. The Company does not assume the
obligation to update any forward-looking statements. CONTACTS: Todd
Young, Angiotech Pharmaceuticals (Analysts & Investors) (604)
221-7676 ext 6933 Rui Avelar, Angiotech Pharmaceuticals, Inc.
(Analysts) (604) 221-7676 ext 6996 Eric Starkman, Starkman &
Associates (Media) (212) 252-8545 ext 12 DATASOURCE: Angiotech
Pharmaceuticals, Inc. CONTACT: Todd Young, Angiotech
Pharmaceuticals (Analysts & Investors), (604) 221-7676 ext
6933; Rui Avelar, Angiotech Pharmaceuticals, Inc. (Analysts), (604)
221-7676 ext 6996; Eric Starkman, Starkman & Associates
(Media), (212) 252-8545 ext 12
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