By Jim Shrine
Gliatech Inc. began enrolling patients in a pivotal trial of its third product from the ADCON family, this one designed to inhibit scarring and adhesions following gynecological surgeries.
ADCON-P, a resorbable, carbohydrate polymer liquid, will be tested in a randomized, double-blind, placebo-controlled study involving about 200 patients. If all goes as planned, Gliatech could be ready to ask the FDA for marketing approval in about a year, said Thomas Oesterling, the company's president and CEO.
Gliatech, of Cleveland, gained U.S. approval of ADCON-L last May for use in lumbar surgeries, and is in pivotal studies in the U.S. with ADCON-T/N, targeted for use in surgeries involving tendons and peripheral nerves.
"In developing the ADCON family of products, we've gotten off to a tremendous start with ADCON-L, especially in the U.S. market," Oesterling told BioWorld Today. "Getting into the U.S. market was a real boost for the company. Now, we have the next member of the family moving into the next stage of development on schedule."
ADCON-L and ADCON-T/N have been approved in Europe since 1995 and 1996, respectively, but the U.S. is the key to increasing sales. Third-quarter revenues of $5.3 million, mostly from ADCON-L in the U.S., were about 10 times more than they were in the same 1997 period.
Oesterling said the pivotal study will follow a protocol very similar to that of the pilot trial, in which statistically significant results were seen in total areas of adhesion; number of adhesions formed after surgery; and percentage of patients free of those adhesion sites.
The pilot study assessed the reduction of peritoneal adhesions following either minimally invasive gynecological surgery or uterine tumor surgery. Patient outcome was evaluated using second-look laparoscopic examination 14 weeks after surgery.
Patients in the pivotal study will be treated with either ADCON-P or a control solution right before closure. After 14 weeks, a laparoscope will be used to measure the extent of adhesions in predefined sites in the cavity. Videos made at the time, and at 14 weeks, will be compared in a blinded fashion and graded for adhesions.
Oesterling said adhesions and scarring following this type of procedure can result in pain and discomfort; can cause tissues and organs to attach to each other; and may even lead to infertility, by blocking the fallopian tube.
There are about 1.3 million procedures each year in the U.S. in which ADCON-P could be used, about three times more than ADCON-L, Oesterling said.
"It's the same type of problems, and ultimately we believe these products will become the standard of care and be used on a prophylactic basis in every procedure," he said.
The submission of a premarket approval application for the ADCON-T/N product, like the filing for ADCON-P, is expected in about a year, Oesterling said. The company has three more adhesion-control products in development: ADCON-A (abdominal); ADCON-I (for implant surgery); and ADCON-C (cardiac). The company expects to make an investigational device exemption filing soon, in order to begin a trial in the abdominal indication, with implant studies targeted for next year, Oesterling said.
Gliatech's stock (NADAQ:GLIA) gained $2.062 Thursday, closing at $29.75.