Angiotech Announces Positive Adhibit Data to Prevent Surgical Adhesions
28 September 2005 - 4:00PM
PR Newswire (US)
- Untreated Patients Had 100% More Adhesions Than Patients Treated
with Adhibit - VANCOUVER, Sept. 28 /PRNewswire-FirstCall/ --
Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP)
today announced positive results from a European pivotal clinical
study conducted to evaluate the safety and efficacy of Adhibit(TM)
Adhesion Prevention Gel for the reduction of surgery induced scars
(adhesions) that can occur after surgery to remove fibroids from
the uterus (myomectomy surgery). The incidence of patients who
suffered from adhesions was 100 percent greater in the group
receiving the current standard of care (control group) as compared
to the treatment group receiving Adhibit (65.0 percent vs 33.3
percent). Safety data also indicated fewer adverse events occurring
with the Adhibit group than the control group. The data will be
presented in its entirety at a major gynecologic conference in the
first half of 2006. Adhibit is a spray gel applied at the time of
surgery that binds directly to the tissue and creates a temporary
barrier, preventing contact and adhesions from forming between
tissue surfaces. This study was conducted at six investigational
sites in Germany, Canada and Curacao. Patients who were scheduled
to undergo myomectomy surgery were randomized to either a treatment
group that received Adhibit spray at the time of surgery (n(equal
sign)48) or a control group (n(equal sign)23). Patients then
returned eight to ten weeks later for a second-look procedure and
were evaluated for both extent and tenacity of adhesion formation.
Uterine fibroids are benign tumors of muscle and connective tissue
that develop within, or are attached to, the uterus. They can be
microscopic in size, or they can grow to fill the uterine cavity
and may weigh several pounds. Fibroids are the most common pelvic
tumor (almost always benign), and they may be present in as many as
70 percent of women, for which surgery (hysterectomy and
myomectomy) is a common treatment. They occur more three to nine
times more frequently in African-American women than in Caucasian
women. Patients with fibroids can experience a spectrum of symptoms
such as: sensation of fullness or pressure in lower abdomen,
cramping or pain with periods, abdominal fullness, gas, increase in
urinary frequency, heavy menstrual bleeding, back pain, or even
infertility. "One of the major challenges to date has been to
deliver an effective adhesion barrier through a laparoscope, a
technique that requires only a very small scar as compared to the
traditional and more disfiguring technique of open surgery," said
Rui L. Avelar, MD, Senior Vice President, Medical Affairs and
Communications. "Adhibit is a sprayable and versatile adhesion
barrier that can serve as a useful tool in women's healthcare and
gynecological surgery." Adhesions occur when normally separate
tissues scar together following surgery or tissue damage. The
incidence of adhesions is remarkably high, particularly among
patients with a history of multiple surgeries (up to 90 percent
adhesion rate) and women with previous gynecologic surgeries (more
than 70 percent adhesion rate). Adhesions can be life threatening
and can make follow up surgeries hazardous. Dissecting adhesions
may cause injury to surrounding organs or blood vessels, increasing
blood loss and prolonging operating time. Adhesions often cause
severe pain, discomfort, limited range of motion and organ
dysfunction. When normally separate organs are bound together by
scar tissue, the stretching and pulling of this tissue from
everyday body movements can cause pain. Adhesions are also a
leading cause of female infertility and bowel obstruction.
Currently approved in Europe to prevent or reduce post-surgical
adhesion formation in pediatric patients undergoing cardiac
surgery, Adhibit(TM) is a completely synthetic, self-polymerizing
liquid hydrogel that is safely metabolized by the body in less than
30 days. Adhibit(TM) is an Angiotech product that is sold and
marketed by Baxter Healthcare Corporation, based on a February 2003
worldwide (excluding U.S.) strategic alliance between Angiotech and
Baxter. Baxter has an option to license Adhibit(TM) in the U.S.;
however, Adhibit(TM) is not currently approved for sale in the U.S.
Vancouver-based Angiotech Pharmaceuticals, Inc. is a specialty
pharmaceutical company pioneering the combination of pharmaceutical
compounds with medical devices and biomaterials to both create
novel solutions for poorly addressed disease states and
dramatically improve surgical outcomes. 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," "may" 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. FOR ADDITIONAL
INFORMATION: --------------------------- Analysts and Investors:
Todd Young, Vice President Investor Relations and Communications,
Angiotech Pharmaceuticals, Inc. (604) 221-7676 ext 6933 Analysts:
Rui Avelar, Senior Vice President Medical Affairs and
Communications, Angiotech Pharmaceuticals, Inc. (604) 221-7676 ext
6996 Media: Wendy Carhart, Waggener Edstrom Bioscience, (503)
443-7354, Email: DATASOURCE: Angiotech Pharmaceuticals, Inc.
CONTACT: Analysts and Investors: Todd Young, Vice President,
Investor Relations and Communications, Angiotech Pharmaceuticals,
Inc., (604) 221-7676 ext 6933; Analysts: Rui Avelar, Senior Vice
President Medical Affairs and Communications, Angiotech
Pharmaceuticals, Inc., (604) 221-7676 ext 6996; Media: Wendy
Carhart, Waggener Edstrom Bioscience, (503) 443-7354, Email:
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