Tuesday October 24, 2:17 pm Eastern Time
Press Release
SOURCE: Gliatech Inc.
Gliatech Announces Results of Study to Assess
Methodology for ADCON(R)-P Clinical Trial
SAN DIEGO, Oct. 24 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA - news) today
announced that several gynecological surgeons participated in a study to assess the adhesion scoring method used in Gliatech's
ADCON®-P pivotal clinical trial. The results of this study are reflected in the Society of Reproductive Surgeons (``SRS'') Prize
Paper Award, which will be presented during the 56th Annual Meeting of the American Society for Reproductive Medicine in
San Diego, California on Wednesday, October 25, 2000.
The presentation to be given by Anthony Bacevice, M.D., Westlake, Ohio, describes the results of a study that tested whether
a 16-site modified ``More Comprehensive Adhesion Scoring Method'' (``MCASM'') is a valid, reliable method for surgeons to
assess adhesions at the time of laparoscopic pelvic surgery. The 16 anatomical site modified MCASM was compared to the
previously used 23 anatomical site method.
The study involved gynecological surgeons from the U.S.A. and Europe. The surgeons independently reviewed videotapes
from laparoscopic pelvic surgeries and assessed the number of adhesions, number of adhesion sites and surface area of
adhesions. The following authors, including the surgeons who conducted the study, assisted Dr. A. Bacevice in writing the
paper:
Dr. E. Bieber, University of Chicago, Chicago, IL.
Dr. R. Dunn, Obstetrical and Gynecological Associates, Houston, TX.
Dr. S. Rosenberg, Richmond Center for Fertility & Endocrinology,
Richmond, VA.
Dr. K. Silverberg, Texas Fertility Center, Austin, TX.
Drs. J. Thorburn and A. Strandell, Sahlgrenska University Hospital, Goteborg, Sweden.
Dr. M. Twede, Physicians Research Options LC, Salt Lake City, UT.
Drs. L. Shaffer and C. Tedford, Gliatech Inc., Cleveland, OH.
Drs. P. Lavin and K. Sciarappa, Boston Biostatistics Inc., Framingham, MA.
Dr. M. Diamond, Wayne State University, Detroit, MI.
``The study demonstrated that the scoring method used in the ADCON®-P pivotal clinical trial is a reliable method for
adhesion assessment,'' stated Clark E. Tedford, Ph.D., Exec. Vice President, Research and Development of Gliatech. ``The
current method is less cumbersome than previous methods and this study will help establish the validity of our measurement of
adhesions in the ADCON®-P clinical trial.''
The pivotal clinical trial evaluated ADCON®-P Adhesion Control Barrier Solution in patients undergoing pelvic-gynecological
adhesiolysis laparoscopic surgery. This trial involved 200 patients at approximately 20 centers in the U.S.A. and Europe.
ADCON®-P is a proprietary, resorbable, carbohydrate polymer solution that is designed to inhibit scarring and adhesions
following peritoneal cavity (pelvic and abdominal) surgery.
``The continued progress in the development of ADCON®-P is further evidence of our goal to establish a family of proprietary
resorbable medical devices designed to inhibit surgical scarring and adhesions,'' said Rodney Dausch, Chief Operating Officer
of Gliatech. ``Surgeons have initially indicated that the product was very easy to use which we believe will be important to its
acceptance.''
Gliatech is engaged in the discovery and development of biosurgery and therapeutic products to improve surgical outcomes and
to treat neurological disorders. The biosurgery products include the ADCON® family of products, which are designed to
inhibit postsurgical scarring and adhesions, and a proprietary monoclonal antibody to treat anti-inflammatory disorders.
Gliatech's neurological disorders programs are focused on development of small molecule drug candidates to modulate the
cognitive state of the nervous system and to treat the symptoms of schizophrenia.
Certain statements in this press release constitute ``forward-looking statements'' that are subject to risks and uncertainties which
may cause the actual results of the Company to be different from expectations expressed or implied by such forward-looking
statements. Such factors include, but are not limited to, uncertainty of market acceptance of the Company's products, the
uncertainty of the success of certain clinical trials, uncertainty of regulatory approvals including the timing and content of
decisions by the FDA and other risk factors detailed in the Company's SEC filings.
SOURCE: Gliatech Inc. |
