Angiotech gets gynaecology study boost for anti-adhesion gel
This article was originally published in Clinica
Angiotech Pharmaceuticals says that its Adhibit adhesion prevention gel has produced encouraging results in a pivotal European trial that is testing the product's ability to reduce the incidence and severity of adhesions following laparoscopic surgery in a gynaecological population.
Preliminary eight-week follow-up data on 20 patients from the single centre study revealed the gel to be associated with an over three-fold improvement in the reduction of lesions. Adhesions were found at only 13.8% of inspected sites in the Adhibit-treated group, versus 46.7% of inspected sites in the control group, the company revealed at this month's American Association of Gynecologic Laparoscopists in San Francisco, California.
The study involves 75 patients in total - randomised 2:1. It is designed to evaluate safety and efficacy of Adhibit for the prevention of post-surgical adhesions (internal scarring) in patients undergoing laparoscopic surgical removal of fibroids from the uterus (myomectomy). Both laparoscopic and traditional open surgical approaches were used. The test group had Adhibit sprayed onto the surgical sites, while the control group was left untreated. The Adhibit-treated group totalled 14 patients, while the control group totalled six.
The study also found Adhibit 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 in myomectomy and other gynaecologic laparoscopic surgeries.
"These data from one centre's experience with Adhibit is very encouraging," said William Hunter, Angiotech's president and CEO. The Vancouver, Canada company said that data from the trial might be used to support a CE-mark application to sell the product in Europe.
Adhibit is already approved in Europe for preventing or reducing post-surgical adhesion formation in patients undergoing cardiac surgery. Angiotech added the gel to its portfolio through its acquisition of Cohesion Technologies. The product is sold, marketed and distributed by Baxter Healthcare, based on a February 2003 worldwide (excluding Japan and certain other territories) strategic alliance with Angiotech. According to Angiotech, industry analysts have estimated the global adhesion prevention market to be in excess of $500m annually. There were approximately 1.6 million gynaecological surgical procedures performed in 2000 in the US alone.
Adhibit is a synthetic, self-polymerising liquid hydrogel that is metabolised by the body in less than 30 days. It takes only one minute to prepare, and is applied with a spray system. It adheres to the tissue where it is applied and remains in place during the critical wound-healing period, when adhesions typically form.