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Biotech / Medical : Gliatech (GLIA) -- Ignore unavailable to you. Want to Upgrade?

To: LLCF who wrote (728)	4/23/1999 6:42:00 PM
From: scaram(o)uche	Respond to of 2001

The emphasis is mine...... A Clinical Study of ADCON(Registered)-L: A Bioresorbable Gel for the Prevention of Postoperative Peridural Fibrosis Meeting: AANS 1999 New Orleans Presentation type: Oral Authors: Stewart Dunsker, MD, William Tobler,MD(Cincinnati,OH),The U.S.ADCON-L Clinical Research Group Abstract: Objectives: ADCON(Registered)-L Adhesion Control in a Barrier Gel, shown to inhibit the development of peridural fibrosis in animals and in a previous clinical study, was evaluated in this clinical study for safety, effectiveness in preventing postoperative adhesions, and improving clinical outcome of patients undergoing lumbar discectomy. Methods: The study was designed as a controlled, randomized, double-blind clinical trial and was conducted at 16 U.S. centers. The studies included patients (N = 370) undergoing first-time, unilateral, single-level, discectomy at the L4/L5 or L5/Sl level. Patients received ADCON(Registered)-L gel or no treatment (Control). Fibrosis was quantified 6 months postoperatively by MRI, and evaluated visually in nine cases of reoperation. Clinical outcome was also assessed. A numerical clinical utility index was developed and calculated for each treatment group based upon decreased peridural scar and improvement in clinical outcome measures. A post-study surveillance was conducted on data from study patients who completed assessments at least 12 months postoperatively. Results: There were a total of 370 patients enrolled into the clinical study. An interim analysis of the data shows that patients receiving ADCON(Registered)-L had significantly less peridural scar as measured by MRI six months postoperatively (N = 141 evaluable patients, p = 0.03). When reoperation was required, the surgeons encountered less fibrosis in the ADCON(Registered)-L patients compared to control patients. ADCON(Registered)-L treatment provided a significant benefit in clinical outcome (p = 0.03). The twelve month data from the post-study surveillance are currently being analyzed and will be discussed. A meta-analysis was performed combining the interim data from this study with final data from a previous clinical study conducted at 9 European centers, and demonstrated further that ADCON(Registered)-L patients had significantly less scar than control patients (p = 0.001, N = 407 evaluable patients). In addition, significantly more ADCON(Registered)-L patients were classified as clinical successes using the clinical utility index in the previous study at 6 months (p = 0.002) and 12 months (p = 0.0 13) postoperatively, and for the interim data from this study (p = 0.002). There were no differences between the ADCON(Registered)-L and control groups in adverse events or wound healing characteristics. Summary: The group of patients who received ADCON(Registered)-L have less scar and a better clinical outcome after laminectomy compared to those patients who did not receive the treatment. ADCON(Registered)-L treatment was safe and effective in reducing postoperative peridural scar and its clinical sequelae.

To: LLCF who wrote (728)	4/23/1999 6:46:00 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 2001

the emphasis is mine..... Inhibiting Postoperative Spinal Fibrosis: Clinical Studies with ADCON-L Meeting: CNS 1998 Seattle, Washington Presentation type: Slide Authors: Stewart Dunsker, M.D., William Tobler, M.D., The ADCON-L Study Group Abstract: Purpose: ADCON¨-L, shown to inhibit the development of peridural spinal adhesions in animals, was evaluated for safety and effectiveness in preventing postoperative adhesions in patients. In addition, the study evaluated the association between fibrosis and clinical outcome. Methods: The studies were designed as controlled, randomized, double-blind clinical trials and were conducted at nine European centers (pivotal study, N = 298), and 16 U.S. centers (supporting study, N = 223 for interim analysis). The studies included patients undergoing first-time, unilateral, single-level, discectomy at the L4/L5 or L5/S1 level. Patients received ADCON¨-L gel or no treatment (Control). Fibrosis was quantified 6 months postoperatively by MRI, and evaluated visually in cases of reoperation. Outcome measures included straight leg raise (SLR) exam, low back pain, and activity-related pain (ARP) in the pivotal, and the Roland Morris Disability Questionnaire (RM) in the supporting study. A numerical clinical utility index was developed and calculated for each treatment group based upon decreased peridural scar and improvement in all clinical outcome measures. A post-study surveillance was conducted on data from pivotal study patients who returned for 12 month postoperative assessments. Results: Pivotal study data shows that extensive scar is significantly associated with recurrent radicular pain (p = 0.004), low back pain (p = 0.03), worse SLR (p = 0.05), and increased ARP (p = 0.008). ADCON¨-L patients had significantly less scar than control patients 6 months postoperatively (p = 0.002), supported by interim analysis of the data from the supporting study (p = 0.005), and maintained to 12 months (p = 0.01). A meta-analysis was performed combining data from both clinical studies, and demonstrated further that ADCON¨'-L patients had significantly less scar than control patients (p = 0.001, N = 407 evaluable patients). When reoperation was required, the surgeons encountered less fibrosis in the ADCON¨*-L patients compared to control patients. Fewer ADCON¨-L patients experienced an increase in ARP (p = 0.013), and ADCON¨-L patients had improved SLR exams (p = 0.037), both of which were maintained at 12 months. ADCON¨-L treated patients had less back pain (p < 0.05) compared to control patients. There was a significant reduction in the RM score for ADCON¨-L treated patients in the interim analysis of the supporting study (p = 0.016). Significantly more ADCON¨-L patients were classified as clinical successes using the clinical utility index for the pivotal study at 6 months (p = 0.002), and 12 months (p = 0.0 13), and for the interim data from the supporting study (p = 0.002). There were no differences between the device and control groups in neurological tests, adverse events or wound healing characteristics. Summary: The group of patients who received ADCON¨-L have less scar and a better clinical outcome one year after laminectomy compared to those patients who did not receive the treatment. ADCON¨-L treatment was safe and effective in reducing postoperative peridural scar.

To: LLCF who wrote (728)	4/23/1999 6:58:00 PM
From: scaram(o)uche	Respond to of 2001

INHIBITION OF POSTOPERATIVE PERIDURAL FIBROSIS WITH A BIORESORBABLE CARBOHYDRATE GEL: ADCON(r)-L Meeting: CNS 1997 New Orleans Presentation type: Oral Presentation Authors: Fred Geisler, M.D., Ph.D., for the ADCON-L Study Group Abstract: Introduction: Peridural scar and adhesions, which develop as a result of the natural healing process after lumbar discectomy, can result in recurrence of clinical symptoms due to dural or nerve root compression. This randomized, controlled, double-blind, multicenter, clinical investigation evaluated the safety and effectiveness of a novel bioresorbable gel (ADCON-L) for the inhibition of postoperative peridural fibrosis and reduction of fibrosis-related symptoms.