Healthcare Industry News: uterine fibroids
News Release - April 7, 2006
Angiotech presents positive Adhibit(TM) data at the 19th annual European Congress of Obstetrics and GynecologySurgical adhesion scores were threefold less in patients treated with Adhibit(TM)
VANCOUVER, BC and TORINO, Italy, April 7 (HSMN NewsFeed) - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced positive results from its Adhibit(TM) Adhesion Prevention Gel Myomectomy Study. The final data set was presented today by Dr. Lilo Mettler, the study's principal investigator, at the 19th Annual European Congress of Obstetrics and Gynecology in Torino, Italy.
About the Study
This randomized, controlled, single-blind, clinical study was designed to evaluate the safety and efficacy of Adhibit in reducing the incidence and severity of post-operative adhesions when applied immediately after the removal of uterine fibroids (myomectomy surgery). The study was conducted at six investigational sites in Europe, Canada, and the Netherlands Antilles.
The trial randomized 71 patients, with 48 patients receiving the Adhibit treatment and 23 patients receiving no post-operative adhesion treatment (the Control group). Patients were surgically re-examined eight to ten weeks post- procedure to determine the incidence and severity of adhesions.
Adhibit was shown to reduce post-operative adhesion formation as measured by the modified American Fertility Society (mAFS) score, a scoring system that factors in both the extent and tenacity of adhesions. Patients in the group that were treated with Adhibit experienced a statistically significant reduction in their mAFS score when compared with those in the Control group (0.8 (+/-) 2.0 Adhibit group versus 2.6 (+/-) 2.2 Control group; p(equal sign)0.010).
"Consistent with preliminary results, we're encouraged and pleased that this data indicates Adhibit is safe and effective," said Dr. Rui Avelar, Chief Medical Officer for Angiotech. "Adhibit also proved itself to be easily delivered through a laparoscope, and has the potential to further advance minimally-invasive surgery in women."
Adhibit is a fully-synthetic, sprayable hydrogel that is safely resorbed by the body over 30 days and is designed to reduce or prevent the formation of post-operative surgical adhesions. Currently approved in Europe to prevent or reduce post-surgical adhesion formation in pediatric patients undergoing cardiac surgery, Adhibit is an Angiotech product that is sold and marketed by Baxter Healthcare Corporation worldwide, excluding the U.S. Baxter has an option to license Adhibit in the U.S.; however, Adhibit is not currently approved for sale in the U.S.
About Angiotech Pharmaceuticals
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical company that discovers and develops innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury or trauma. To find out more about Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), please visit our website at www.angiotech.com.
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Source: Angiotech Pharmaceuticals
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